Clinical UM Guideline

This document addresses the use of soft tissue (e.g., skin, ligament, cartilage, etc.) substitutes in wound healing and surgical procedures.

Note: This document does not address:

• The use of fresh, unfrozen, unprocessed allogeneic cadaver-derived skin grafts; or
• The use of meshes or patches when used for standard hernia repair procedures; or
• Products used to treat osteochondral defects (for information on such products, please refer to the applicable guidelines used by the plan).

Note: For additional information please see:

• ANC.00007 Cosmetic and Reconstructive Services: Skin Related
• ANC.00008 Cosmetic and Reconstructive Services of the Head and Neck
• MED.00110 Silver-based Products for Wound and Soft Tissue Applications
• MED.00132 Autologous Adipose-derived Regenerative Cell Therapy
• SURG.00011 Products for Wound Healing and Soft Tissue Grafting: Investigational
• SURG.00023 Breast Procedures; including Reconstructive Surgery, Implants and Other Breast Procedures
• TRANS.00035 Therapeutic use of Stem Cells, Blood and Bone Marrow Products

Note: See definition section for information on The Women’s Health and Cancer Rights Act of 1998 (WHCRA).

Medically Necessary:

I. Breast Reconstruction Surgery

The following products are considered medically necessary when used for breast reconstruction surgery:

1. AlloDerm Regenerative Tissue Matrix (aseptic or sterile); or
2. Cortiva^®; or
3. DermACELL^™; or
4. DermaMatrix^®; or
5. FlexHD^®; or
6. SimpliDerm^™; or
7. Strattice^™; or
8. SurgiMend^®.

II. Burns

The following products are considered medically necessary when used for the treatment of full-thickness or deep partial-thickness burns:

1. Biobrane; or
2. Epicel^®; or
3. EZ Derm^™; or
4. Fresh frozen unprocessed allograft skin products (for example, AlloSkin^™*, TheraSkin^®); or
5. Integra^™ Bilayer Matrix Wound Dressing; or
6. Integra^® Omnigraft Dermal Regeneration Template; or
7. ReCell^™ Autologous Harvesting Device; or
8. StrataGraft^®

*Note: “AlloSkin,” “AlloSkin RT^™,” and “Alloskin^™ AC” are different products. AlloSkin is a fresh-frozen product, AlloSkin RT is a fresh irradiated product (not frozen) and Alloskin AC is an acellular dermal matrix product. Please see SURG.00011 investigational and not medically necessary statement for the position on AlloSkin RT^™ and Alloskin^™ AC.

III. Diabetic Foot Ulcers

The following products are considered medically necessary for the treatment of diabetic foot ulcers when the clinical criteria below have been met:

1. Products:
   1. AmnioBand^®, sheet or membrane form; or
   2. Apligraf^®; or
   3. Biovance^®; or
   4. DermACELL^™; or
   5. Dermagraft^®; or
   6. EpiCord^®; or
   7. EpiFix^™; or
   8. Grafix^® PRIME; or
   9. Kerecis^®; or
   10. mVASC; or
   11. NuShield^®; or
   12. Oasis^® Ultra Tri-Layer Wound Matrix; or
   13. Oasis^® Wound Matrix; or
   14. TheraSkin^®;
       and
2. Clinical Criteria:
   1. Ulcers that have not healed with standard conservative therapy (such as surgical debridement, complete off-loading, and standard dressing changes) attempted for at least 1 month.

IV. Dystrophic Epidermolysis Bullosa

The following products are considered medically necessary for the treatment dystrophic epidermolysis bullosa:

1. Dermagraft^®; or
2. OrCel^™

V. Non-healing Wounds

The following products are considered medically necessary for the treatment of non-healing wounds (for example but not limited to; complex wounds, dermal wounds, pressure ulcers, surgical wounds, traumatic wounds, vascular ischemic ulcers, venous stasis ulcers) when the clinical criteria below have been met:

1. Products:
   1. AlloDerm Regenerative Tissue Matrix (aseptic or sterile); or
   2. AmnioBand, sheet or membrane form; or
   3. Apligraf^®; or
   4. EpiFix™; or
   5. GraftJacket™, sheet or membrane form; or
   6. Oasis^® Ultra Tri-Layer Wound Matrix; or
   7. Oasis^® Wound Matrix;
   8. OviTex^™;
   9. PriMatrix^™; or
   10. Phasix^™ Mesh; or
   11. Phasix^™ ST Mesh; or
   12. Strattice^™; or
   13. TheraSkin^®;
       and
2. Clinical Criteria:
   1. Wounds that have not healed with standard conservative therapy (such as surgical debridement, complete off-loading, standard dressing changes, and compression therapy) attempted for at least 1 month.

VI. Ocular Indications

Amniotic membrane-derived graft or wound covering products are considered medically necessary for any of the following ocular indications:

1. To facilitate reconstruction of large conjunctival or corneal resections (for example, pterygium excision or excision of conjunctiva related to disease processes); or
2. As therapy for corneal injuries (for example, thermal, chemical, physical trauma); or
3. As treatment for non-healing or persistent corneal epithelial defects including ulcers or melts, which have not responded to conservative therapy*, including those due to any of the following conditions:
   1. Bullous keratopathy; or
   2. Dry eye; or
   3. Limbal stem cell deficiency; or
   4. Neurotrophic keratitis; or
   5. Recurrent pterygium; or
   6. Stevens-Johnson syndrome

*Conservative therapies for corneal epithelial defects may include frequent topical lubrication, pressure patching, and bandage contact lenses.

Note: Examples of amniotic membrane-derived grafts include AmbioDisk, AmnioGraft, AmnioPlast, Artacent Ocular, Biovance 3L Ocular, Omnigen, Opticyte, Prokera, SurSight, and Vendaje Optic.

Not Medically Necessary:

For each proposed use above (Breast Reconstruction, Burns, Diabetic Foot Ulcers, Dystrophic Epidermolysis Bullosa, Non-Healing Wounds, and Ocular Indications), use of products other than those explicitly listed for the indication is considered not medically necessary. (For example, use of an amniotic membrane-derived product considered medically necessary in the Ocular Indications section above is considered not medically necessary for the use in breast reconstructive surgery, treatment of dystrophic epidermolysis bullosa, or other non-ocular indications).

The following codes for treatments and procedures applicable to this guideline are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

I.  Application of skin substitutes and soft tissue grafts:

When services may be Medically Necessary when product criteria are met:

When services are Not Medically Necessary:
For the procedure codes listed above when product criteria are not met.

II.  Products

When services may be Medically Necessary when criteria are met for breast reconstruction:

When services may be Medically Necessary when criteria are met for burns:

When services may be Medically Necessary when criteria are met for diabetic foot ulcers:

When services may be Medically Necessary when criteria are met for epidermolysis bullosa:

When services may be Medically Necessary when criteria are met for nonhealing wounds

When services are Not Medically Necessary:
For the product codes listed above when criteria are not met, or when the code describes a procedure indicated in the Clinical Indications section as not medically necessary.

III.  Application of amniotic membrane-derived grafts or wound coverings for ophthalmologic conditions:

When services may be Medically Necessary when criteria are met:

When services are Not Medically Necessary:
For the procedure codes listed above when criteria are not met or for all other diagnoses not listed.

General considerations

There are many different products (see definition section for product types) available for soft tissue grafting and wound treatment. These products differ in source (e.g., human cadaveric, synthetic, bovine, porcine, equine, a combination of several types, etc.), tissue (e.g., dermis, pericardium, intestinal mucosa, etc.), bioburden reduction (e.g., nonsterile, sterile), additives (e.g., antibiotics, surfactants), delivery formats (e.g., wet packaged, freeze-dried), and preparation requirements (e.g., multiple rinses, rehydration). Additionally, products are often procured, produced, manufactured, or processed in sufficiently different manners such that product are evaluated based on product specific evidence rather than as a category or class of equivalent products. Products for which there is a lack of published and peer-reviewed evidence showing material improvement to the net health outcome are addressed in a related document: SURG.00011 Products for Wound Healing: Investigational.

Unlike products approved through the PMA process or authorized under the 510K process which are assigned specific indications for use by the U.S. Food and Drug Administration (FDA), there are no authorized indications for products regulated through the FDA Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) process as human tissue for transplantation. Use of HCT/P products is therefore guided by the available published and peer reviewed literature among other factors.

Wound products as part of the treatment of DFUs or non-healing wounds are used when standard therapy has not resulted in wound healing. Standard therapy generally includes debridement as appropriate to a clean granular base, offloading for DFUs, compression dressings for VLUs, infection control with removal of foreign body or focus of infection, and management of exudate with maintenance of a moist environment. In addition, attention should be paid to other factors impacting wound healing including smoking.

Wound care should be well documented and include objective measurements of wound size and depth before, during and after treatment. Wound measurements should be documented before and after each application of a wound product. Clinical records should describe the planned skin replacement with choice of skin substitute graft/CTP.

Breast Reconstructive Surgery

In breast reconstruction, tissue substitutes are utilized to replace or supplement natural tissue, typically after mastectomy or lumpectomy, to restore breast appearance. They provide volume, shape, and support while aiding healing and enhancing cosmetic results. These substitutes are particularly useful when there is insufficient natural tissue available or a less invasive procedure is desired. Options include acellular dermal matrices, synthetic meshes, and fat grafting, with selection influenced by individual needs, surgical objectives, and surgeon preferences. Relevant citations for each listed product can be found in the bibliography section of this document.

(Return to Clinical Indications)

Burns

Tissue substitutes play a crucial role in burn treatment by offering wound coverage and promoting healing. They protect wounds from infection and injury, maintain moisture, alleviate pain by limiting air exposure, and support tissue growth for functional and cosmetic skin restoration. In severe cases, they serve as temporary covers until natural healing or skin grafts are viable. These substitutes can be synthetic or biological, with choice influenced by burn severity, wound location, the individual’s condition, and treatment objectives. Relevant citations for each listed product can be found in the bibliography section of this document.

(Return to Clinical Indications)

Diabetic Foot Ulcers (DFUs)

Tissue substitutes are used to treat DFUs to aid in healing and provide benefits addressing the unique challenges posed by these types of wounds. Tissue substitutes can provide a scaffold that supports cell migration and tissue regeneration, promoting faster healing, they are a protective barrier, reducing the risk of infection due to impaired immune responses, and they can help keep the wound environment conducive to healing by preventing excessive dryness or moisture. Some tissue substitutes contain growth factors or are designed to elicit the body's own healing response and speed up the tissue regeneration process. Products vary in composition, including synthetic materials and bioengineered skin equivalents, each chosen based on the specific needs of the wound and overall management strategy. Relevant citations for each listed product can be found in the bibliography section of this document.

(Return to Clinical Indications)

Dystrophic Epidermolysis Bullosa

Tissue substitutes are employed in managing Epidermolysis Bullosa (EB), a genetic condition causing fragile, blistering skin. They provide benefits including protecting the underlying skin from further trauma and infection, promoting more efficient wound healing by providing a scaffold for cell growth and aiding in the regeneration of tissue, reduced pain, and maintaining a moist wound environment for healing which can help prevent scab formation and subsequent blistering. They may also reduce scar formation which helps maintain skin function and appearance. While primarily therapeutic, tissue substitutes may also help achieve a more normal skin appearance and functionality and can improve the quality of life by reducing the frequency of wound dressing changes, promoting better healing, and minimizing complications associated with chronic wounds. Relevant citations for each listed product can be found in the bibliography section of this document.

(Return to Clinical Indications)

Non-Healing Wounds

Tissue substitutes are used for non-healing wounds to facilitate the healing process. They provide a scaffold that supports cell migration and new tissue growth, function as a barrier to help protect the wound from bacterial exposure, thereby reducing the risk of infection, they help maintain an optimal moisture balance, and may reduce pain associated with dryness and exposure to environmental factors. Some tissue substitutes include components that actively support and enhance the body's own regenerative processes. Tissue substitute products can be derived from natural materials, synthetic sources, or a combination of both. Product selection depends on the wound's specific characteristics and the individual’s needs. Tissue substitutes are often used when traditional treatments, like dressings and topical therapies, have not been successful in promoting healing. Relevant citations for each listed product can be found in the bibliography section of this document.

(Return to Clinical Indications)

Ocular Indications

Amniotic membrane-based wound products are used for the management of select ophthalmologic wounds and reconstruction of large conjunctival resections where there is limited access to autologous tissue for transplant, or when allogeneic transplant is not appropriate. Some amniotic membrane based wound products used are obtained directly from tissue banks while others are commercially available products.

Several branded amniotic-membrane derived products have been used to treat ocular conditions due to their unique biological properties. These products are regulated through the FDA HCT/P process as human tissue for transplantation. Some examples of such products are AmbioDisk, AmnioGraft, AmnioPlast, Artacent, Biovance 3L Ocular, Omnigen Ocular, and Opticyte.

Prokera is a amniotic product device that is intended to treat ocular surface diseases such as dry eye syndrome, corneal scars, and chemical burns. It is for use in eyes in which the ocular surface cells have been damaged, or the underlying stroma is inflamed and scarred. Prokera is a biologic corneal bandage that's made from amniotic tissue. It is composed of amniotic-membrane fastened to a synthetic ring, the device is inserted in between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions. Prokera was cleared through the FDA’s 510K process.

(Return to Clinical Indications)

Other Proposed uses of Wound Products:

Additional uses for wound products continue to be investigated. As evidence is developed showing additional products or additional uses are in accordance with generally accepted standards of medical practice (for these purposes, "generally accepted standards of medical practice" means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, national physician specialty society recommendations and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors) these products and uses will be added to the those identified above as medically necessary.

AlloDerm for Graves’ Disease

In the one available clinical trial of aseptic AlloDerm in people with lid retraction due to Graves’ disease, only 14 participants were studied in a non-blinded fashion (Sullivan, 2003).

A retrospective non-randomized case series involving 54 participants (95 eyes) with Graves’ orbitopathy who underwent swinging eyelid orbital decompression was reported by Kim (2017). The participants were divided into 3 groups: 1) conjunctival lengthening using AlloDerm (36 eyes), 2) inferior retractor recession (33 eyes), and 3) decompression only (26 eyes). Participants in groups 1 and 2 showed correction of eyelid retraction at 4 to 6 months (2.7 mm and 1.8 mm, respectively). Mean improvement in margin reflex distance-2 at 4 to 6 months was significantly better in the AlloDerm group vs. the other two groups (p<0.001). Similarly, the mean reduction in inferior scleral show at baseline to 4 to 6 months after surgery was also significantly better in group 1 vs. group 2 and group 3 (p<0.001). All 3 groups achieved good surgical results. The author concluded that the use of AlloDerm resulted in better outcomes when compared to inferior retraction recession or decompression only. While promising, further controlled studies with larger numbers of participants are needed to confirm these findings.

AlloDerm for Burns

There are currently two studies available in the peer-reviewed literature addressing the use of aseptic AlloDerm for treatment of burns. The first study involved 19 participants randomized to aseptic AlloDerm with an autograft overgraft vs. aseptic AlloDerm with an allograft overgraft which was replaced with an autograft overgraft after 1 week (Munster, 2001). Graft uptake was not different between groups. Immediate use of aseptic AlloDerm with thin autograft was associated with more healing than spilt thickness grafts. The second study involved 52 nonrandomized participants all of whom received aseptic AlloDerm covering to radial arm free flap donor sites (Sinha, 2003). The results of this study indicated that there were minimal contractures or restrictions to the healed graft. While these studies suggest some benefit from the use of aseptic AlloDerm for burns, larger randomized trials are needed to confirm efficacy of this procedure.

AlloDerm for Frey’s Syndrome

At this time, there are two available studies in the peer-reviewed literature regarding the use of aseptic AlloDerm to treat Frey’s syndrome. The first involved 64 participants randomly assigned to the use of aseptic AlloDerm placement in the parotid bed following removal of the parotid gland vs. no aseptic AlloDerm (Govindaraj, 2001). While the rate of gustatory sweating in the aseptic AlloDerm group was found to be statistically lower than the control group, the aseptic AlloDerm group also had an almost three-fold increase in complications, including both a higher frequency of seroma as well as one wound infection. In a second study, 30 participants were randomized into 3 groups; (1) superficial parotidectomy with placement of aseptic AlloDerm, (2) superficial parotidectomy without placement, and (3) deep-plane rhytidectomy (Sinha, 2003). The incidence of both subjective and objective Frey’s syndrome was significantly higher in group 2 when compared to both groups 1 and 3. However, given the small numbers of participants in each group, the results of this study do not allow strong conclusions to be drawn as to the effectiveness of this procedure.

While AlloDerm has been used for a wide variety of other indications, including insufficient conjunctiva (Park, 2017), such uses have been poorly studied and are not widely accepted by the practicing community.

Biobrane for Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis (SJS-TEN)

The use of Biobrane has been reported in a case series study of 18 participants with SJS-TEN (Rogers, 2017). The authors reported that there were no complications, infections, premature removals, or Biobrane-associated sepsis in 24/25 applications (96%). Time to healing was 13 (12-16) days, and mean burn center length of stay was 34 days. This study demonstrates promising data regarding the safety and efficacy of Biobrane for SJS and other conditions.

Cortiva for abdominal wall reconstruction

The use of Cortiva for abdominal wall reconstruction was reported by Lindsey in 2020. This retrospective chart review involved 82 participants who underwent abdominal wall reconstruction with either AlloDerm (n=53) or Cortiva (n=29). The overall complication rate was found to be not significantly different between groups (51.92% in the AlloDerm group vs. 72.41% in the Cortiva group, p=0.099). No explantations were reported. This was the first peer-reviewed, published description of Cortiva for the treatment of abdominal wall reconstruction procedures. Additional data is needed to fully evaluate the clinical utility of this technique

DermaMatrix for Parotid Surgery

DermaMatrix, a product composed of acellular human dermis, has been studied for a variety of indications. It is treated as human tissue for transplantation under the FDA’s HCT/P process.

Athavale and colleagues published the results of a retrospective, non-controlled study of the complication rate for parotid reconstruction surgery involving 100 participants who received treatment with either aseptic AlloDerm (n=69) or DermaMatrix (n=31) (2012). Sixty-nine AlloDerm implants were associated with a total of 5 complications (7%), whereas 31 DermaMatrix implants were associated with a total of 8 complications (26%) (p=0.0107). Subgroup analyses found that for subtotal parotidectomies, the incidence of complications was found to be 8% for the AlloDerm group and 37% for the DermaMatrix group (p=0.004). The authors conclude that:

…this study suggests that DermaMatrix was associated with increased postoperative complications compared with AlloDerm when used for reconstruction of parotidectomy defects. To better define the complication profile of AlloDerm versus DermaMatrix in the postoperative parotid bed, a prospective study should be considered to determine implant performance following parotidectomy reconstruction.

EpiFix for Neurovascular Bundle Surgery

In 2015, Patel and others published the first study to address the use of EpiFix as a protective measure for the prostatic neurovascular bundle during nerve-sparing robot-assisted prostatectomy. This prospective study involved 58 potent and continent participants who underwent the procedure compared to 58 propensity-matched participants who underwent the same procedure without the use of EpiFix. It was reported that continence at 8 weeks returned in 81.0% of the EpiFix participants vs 74.1% of the control participants (p=0.373). Mean time to continence was enhanced in the EpiFix participants vs. controls (1.21 months vs. 1.83 months; p=0.033). Potency at 8 weeks returned in 65.5% of the EpiFix participants vs. 51.7% of the controls (p=0.132). Mean time to potency was enhanced in the EpiFix group vs. controls (1.34 months vs. 3.39 months; p=0.007). The authors concluded that the use of EpiFix appeared to hasten the early return of continence and potency in participants following nerve-sparing robot-assisted prostatectomy. However, the results of this unblinded nonrandomized study need to be further investigated and a large well-controlled blinded trial is warranted.

EpiFix for Mohs Micrographic Surgery

Toman (2021) published the results of a retrospective case-control study involving 286 participants who underwent Mohs micrographic surgery of the face, head, or neck with the use of EpiFix or autologous tissue-based procedures, including full-thickness skin grafts (FTSG) and flaps (n=143, respectively). In univariate analysis, the authors reported that participants in the EpiFix group had no postoperative complications vs. the autologous tissue group participants (97.9% vs. 71.3%, p<0.0001, RR=13.67). The EpiFix group also experienced significantly fewer infections (p=0.004), better scar cosmesis (p<0.0001), fewer scar revisions (p<0.0001), and fewer surgical reinterventions at the index site (p=0.0007). The autologous tissue group required fewer mean (SD) follow-up visits (2.5 vs. 3.4, p<0.0001). In a multivariate analysis controlling for defect surface area, operation time, age, medical history, and gender, use of autologous tissue remained an independent significant risk factor for infection or additional operation (OR, 11.71, p<0.0001). The authors also reported the results of an analysis that included cosmetic outcomes. The results indicated that the odds of infection, additional operation, poor scar cosmesis, or scar revision were 19-times higher in autologous group (OR,18.76, p<0.0001). Finally, they found that being a natal female was also associated with 3-times greater odds of having a cosmetic complication (OR, 2.84, p=0.010).

Fresh Frozen Unprocessed Allograft Skin for non-healing DFU’s and Dermal Wounds

Towler, 2018 Apligraf (n=12) to TheraSkin (n=15) for the treatment of VSUs. The authors reported no statistical differences between groups with regard to time to complete healing at 12 or 20 weeks (p=0.294 and p=0.569, respectively). Additionally, no differences were noted between groups with regard to the number of grafts needed (p=0.119). No adverse events were reported for either group. The authors concluded that both products are safe and effective to treat VSUs. However, the study was limited by small sample size, lack of blinding and other methodological issues.

Armstrong (2022) conducted a randomized, prospective, evaluator-blinded study which compared the response of 100 participants with non-healing DFU’s, 50 of which were treated with TheraSkin and 50 treated with SOC. A total of 23 participants withdrew from the trial, 4 in the TheraSkin group and 19 in the control group. In the TheraSkin group 1 was removed for not achieving > 50% area reduction by 6 weeks, 1 for wound worsening, and 2 due to adverse events, 1 potentially related to the study treatment and the other not related. In the control group, 11 participants were removed for not achieving > 50% area reduction by 6 weeks, 1 due to reopened wound, 3 due to serious adverse events, 2 which were potentially treatment related, and 4 due to adverse events, 1 of which was possibly related to study treatment. In the ITT analysis the results at 12 weeks showed that 76% (38/50) of the TheraSkin-treated DFUs healed compared to 36% (18/50) of controls treated with SOC (adjusted p=0.00056). The mean percent area reduction at 12 weeks was 77.8% in the TheraSkin group vs. 49.6% in the SOC group (adjusted p=0.0019). The average time for closure within the 12-week period was 46.9 days for the TheraSkin group vs. 65.3 days for controls (p=0.0019). The authors concluded that wounds treated with TheraSkin in addition to SOC improved wound healing compared to SOC alone.

Grafix PRIME for Non-DFU Dermal Wounds

In 2017, Johnson and others published a report of a retrospective nonrandomized study comparing the outcomes from two separate cohort studies involving Grafix PRIME (n=40) or Epifix (n=39) for the treatment of a variety of wounds including VSUs, surgical wounds, DFUs, arterial ulcers, pressure ulcers, and ‘other’ wounds. The authors reported that the proportion of wounds achieving complete wound closure was 63.0% (29/46) for the Grafix group and 18.2% (10/55) for the Epifix group (OR=7.5, p<0.0001) for all treated wounds combined. When analyzed by wound type, the results indicated that treatment with Grafix group had a significantly higher rate of completely closed VSUs (70% vs. 7%, p=0.0024) and surgical wounds (81.9 vs. 18.2%, p=0.009). The small number of participants, and retrospective, non-random, and unblinded methodology used in this study impair the generalizability of the results.

Another published case series study addressed the use of Grafix PRIME and included 67 wounds in 66 participants with either DFUs (n=27), VSUs (n=34), or other chronic wounds (n=6) (Regulski, 2013). At 12 weeks, 51 of 67 wounds (76.1%) were healed. By wound type, 23 of 34 (67.6%) VSUs and 23 of 27 (85.2%) DFUs were healed at 12 weeks. The average time to closure in these wounds was 5.8 (± 2.5) weeks. No significant differences were reported between the two wound type groups, and no adverse events or recurrences were reported.

GraftJacket for DFUs

One randomized controlled trial compared the use of standard surgical debridement of DFUs followed by GraftJacket placement vs. standard surgical debridement alone (20 participants in each group) (Brigido, 2004). The findings of the study demonstrated significant differences between the two groups, with the experimental group demonstrating much faster healing progression. While the results of this study are promising, the small sample size, as well as its single-blind design, limits its utility. The same authors conducted a second RCT with 28 participants with chronic DFUs who were assigned to receive either GraftJacket (n=14) or standard care (n=14) (Brigido, 2006). At 16 weeks, 12 of 14 (85.7%) of the GraftJacket participants demonstrated complete wound closure, compared with 4 of 14 (28.6%) in the control group (p value not provided). Participants treated with GraftJacket demonstrated a statistically significant higher percentage of wound healing with respect to wound area, and clinically significant differences in wound depth and wound volume (p<0.001).

Reyzelman (2009) reported the results of an RCT involving 85 participants with DFUs assigned to receive treatment with either GraftJacket (n=46) or standard care (n=39). The authors reported significantly better complete and mean healing times in the GraftJacket group (69.6% and 5.7 weeks) compared to the controls (46.2% and 6.8 weeks) who received standard care (p=0.029). Furthermore, there was a significantly higher non-healing rate for the control group (53.9%) compared with the study group (30.4%) at 12 weeks (p=0.015). Neither the participants nor the investigators were blind to group assignment.

A prospective non-blind RCT involving 168 participants with DFUs assigned in a 2:2:1 fashion to treatment with DermACELL (n=71), conventional care (n=69), or Graftjacket (n=28) (Walters, 2016). At 16 weeks post intimal treatment, no significant differences in the proportion of completely healed ulcers vs. the conventional care group was found (67.9% vs 47.8%; p=0.1149). No differences between groups were reported with regard to severe adverse events (p≥0.05).

Cazzell (2017) conducted an RCT involving 132 participants with chronic DFUs undergoing treatment in 2:2:1 fashion with either DermACELL (n=53), conventional care (n=56), or GraftJacket (n=23). Participants were followed through 24 weeks, with endpoint measurement at 12, 16, and 24 weeks. GraftJacket did not show a significantly greater healing rate over conventional care at any of these time points. No significant difference was noted between the GraftJacket group vs. the conventional care group for healed wounds remaining closed. However, as noted above, the results of this comparison for GraftJacket are significantly hampered by small numbers of participants, and the results should be viewed with that in mind.

GraftJacket for Tendon Injuries (e.g., rotator cuff)

GraftJacket has also been proposed for use in shoulder surgery to repair soft tissue injuries. Barber and colleagues (2012) reported on an RCT involving 42 participants with rotator cuff injuries randomized to undergo repair with GraftJacket (n=20) or standard surgical procedures (n=22). At the 2-year follow-up period, significant benefits were noted on several scales, including the American Shoulder and Elbow Surgeons (ASES) (p=0.035) and Constant (p=0.008) assessment tools. No significant difference was seen on the University of California, Los Angeles (UCLA) tool (p=0.43). Imaging studies found that at 2 years, 85% of the GraftJacket group had intact grafts, compared to only 40% in the standard care group (p<0.01). A prospective case series study by Gupta and others (2012) involved 24 participants with rotator cuff tears treated with GraftJacket and followed for 3 years postoperatively. The authors report significant improvements with regard to pain, (p=0.002), mean active forward flexion and external rotation (p=0.002), mean shoulder abduction (p=0.0001), supraspinus strength (p=0.0003), and ASES scores (p=0.0003). Ultrasonography showed 76% of repairs were fully intact, with the remainder of participants with partially intact repairs.

GraftJacket for Osteoarthritis

Marks and colleagues (2017) reported on a study involving the use of GraftJacket for the treatment of 60 participants with osteoarthritis at the first carpometacarpal (CMC I) joint who underwent treatment with either trapeziectomy with suspension-interposition arthroplasty using the flexor carpi radialis (FCR) tendon (n=29) or GraftJacket (n=31). They reported that baseline Michigan Hand Outcomes Questionnaire (MHQ) total scores significantly increased from 51 to 83 in the FCR group and 53 to 76 in the GraftJacket group by 12 months (p<0.05 for both). No differences between groups were reported (p>0.05). Complications were reported in 5 FCR-related participants, and 10 in the GraftJacket group (p=0.24). Revision surgery was required for 1 allograft recipient. They concluded that the use of the FCR tendon or GraftJacket for trapeziectomy with suspension-interposition arthroplasty leads to similar outcomes, but with more complications, mainly tendon irritations, associated with GraftJacket. They noted that they “only use the allograft in cases of severe instability requiring a larger amount of suspension-interposition material or for revision procedures after failed suspension-interposition with the FCR tendon.”

Integra Bilayer Matrix Wound Dressing for Cutaneous Scalp Defects

Othman (2021) reported the results of a retrospective case series study involving the use of Integra Bilayer Matrix Wound Dressing for the treatment of cutaneous scalp defects in 127 participants older than 60 years of age. The reconstructive procedures were conducted in a 2-stage fashion, with the wound first being treated with Integra followed by STSG between 3-4 weeks afterwards. A total of 107 (84%) participants were successfully reconstructed. The 20 participants who had treatment failure were more likely to have a history of radiotherapy (30% in the failure group vs. 12% in the success group, p<0.04). Place of service was noted as a significant factor in treatment failure, with 25% of participants treated in the inpatient setting having failure vs. 8% of participants treated in the outpatient setting (p<0.034). The authors noted that postoperative wound infection was significantly associated with reconstructive failure (30% vs. 6.5%, respectively; OR, 6.4, p<0.006). The results of this study are promising, but the methodology used does not allow generalization of these findings to a wider population.

Integra OmniGraft Dermal Regeneration Template for DFUs

In 2015, Driver and colleagues reported the results of an RCT involving 307 participants with DFUs assigned to treatment with either standard care (n=153) or treatment with Omnigraft (n=154) and followed initially for 16 weeks or until confirmation of complete wound closure, and then for a further 12 weeks. The investigators reported that complete DFU closure during the treatment phase was significantly greater with Omnigraft vs. control treatment (51% vs. 32%; p=0.001). The median time to complete DFU closure was 43 days for Omnigraft participants vs. 78 days for controls, in wounds that healed. The rate of wound size reduction was significantly better in the Omnigraft participants (7.2% per week vs. 4.8% per week, p=0.012). They concluded that for the treatment of chronic DFUs, Omnigraft treatment decreased the time to complete wound closure, increased the rate of wound closure, improved components of quality of life and had less adverse events compared with the standard of care treatment.

Hicks and others (2020) reported the results of a case series study that included 85 participants treated with Omnigraft who underwent surgical procedures for debridement of a DFU or gangrene resulting in complex post-surgical DFUs. Overall, 107 wounds were treated, with 45.8% involving the forefoot, 23.4% the heel, 19.6% the midfoot, 5.6% the ankle, and 5.6% the lower leg/Achilles tendon. Bone involvement due to acute or chronic osteomyelitis occurred in 71.7%. Most participants were at high risk for amputation based on Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) classification score (6.4% were WIfI classification score 4). Overall success rate for all initial dermal regeneration template applications was 66.7%, with the majority of wounds (81.3%) receiving one dermal regeneration template application. Two applications were reported in 15.9% of cases and three applications in 2.8%. Mean time to complete healing was 198 ± 18 days. Location of the wound on the forefoot was associated with significantly better healing (HR, 5.2) as was the presence of bone involvement (HR, 1.86). While these results are promising, the lack of a comparison group and other methodological weaknesses limit their generalizability.

Integra OmniGraft Dermal Regeneration Template for Cutaneous Scalp Defects

In 2021 Mogedas-Vergara described a retrospective cohort study involving 70 participants with skin cancer undergoing scalp reconstruction procedures. All participants were over 65 years or age. Each participant underwent 2-stage procedures involving a first stage where Integra Derma Regeneration Template was used followed by the application of a STSG after 3-4 weeks. The mean surface area treated was 23 cm² and the mean interval between stages was 30.6 days. Seven participants (10%) did not undergo a second-phase procedure due to rapid wound epithelialization. The Integra and skin graft success rates were 87.1% and 100%, respectively. A total of 13 participants (18.6%) developed infections. In 4 participants (5.7%) the infection caused partial Integra loss, which was treated via debridement and antibiotics and no need to reconsider placement of the graft. Infection resulted in total loss of the Integra graft in in 9 participants (12.9%) and healing was completed by second intention without major complications. Mean wound epithelization in this subgroup of 13 participants was 60.33 days and no other complications were recorded. The results of this study are promising, but the methodology used does not allow generalization of these findings to a wider population.

Integra OmniGraft Dermal Regeneration Template for Skin Donor Site Sites

Falcone (2023) reported on the results of a retrospective comparative study involving the use of single-layer Integra to treat allogenic radial artery forearm free-flap skin donor site sites during total phallic construction. A total of 34 participants were included, 18 who received FTSG alone and 16 who received Integra covered by a STSG. The authors reported significantly better healing time in the Integra group vs. the FTSG group (24 days vs. 30 days, p=0.003). Similarly, the Integra group had significantly better complete graft take (93.8% vs. 27.8%, p=0.001), shorter operative times (310 min vs. 447 min, p=0.001), and median hospital stay (8 days vs. 10 days, p=0.001). This was the first study of its kind to be published. The results are promising, but additional data from more robustly designed and conducted trials is warranted to better understand the role of Integra for the treatment of free-flap donor sites.

Kerecis^™ Omega3 for Surgical Wounds

The available evidence addressing the clinical safety and efficacy of Kerecis is limited. A double-blind, parallel-group non-inferiority RCT involving 81 participants with 162 full-thickness surgical wounds was reported by Baldursson in 2015. Each participant underwent the creation of two 4 mm full thickness wounds made on the proximal anteriolateral aspect of their non-dominant arm, 2 cm apart. Each participant had one wound treated with Kerecis and the other wound with Oasis porcine-derived graft product and were followed for 28 days. At the study endpoint, 95% (76/80) of wounds in the Kerecis group and 96.3% (79/82) of wounds in the Oasis group were healed. The authors reported that this result was within the 95% two-sided confidence interval for non-inferiority margin of 0.1. They also noted that the OR of a Kerecis-treated wound being healed vs. an Oasis-treated wound was 4.75 (p=0.041), indicating that Kerecis added significantly faster wound healing vs. Oasis. No significant immunological responses were noted in the Kerecis group. While the findings of this study are interesting, they do not provide data regarding performance of the product in the populations for which they are proposed, specifically, those with impaired healing and chronic wounds. The results involving experimentally created wounds are not useful in informing the discussion of the clinical utility of Kerecis Omega3 in the real-world setting for the treatment of individuals with impaired healing function.

Another study addressing the clinical outcomes of Kerecis has been published (Yang, 2016). However, this study involved only 5 participants, limiting the generalizability of the results, and did not involve any comparison group. The value of this publication in understanding the generalizable safety and efficacy of Kerecis is limited.

Kirsner (2020) published the results of a double blind RCT involving 85 healthy participants who had two investigator-created full thickness punch biopsy wounds randomly assigned to treatment with either Kerecis or EpiFix. A total of 170 wounds were treated. The authors stated that the Kerecis-treated wounds healed significantly faster than the EpiFix-treated wounds (HR, 2.37, p=0.0014). No differences between groups were reported with regard to adverse or serious adverse events. These results indicate that Kerecis is similar to EpiFix in the treatment of acute surgical wounds. However, as with the Baldursson study previously discussed, this study did not adequately reflect the actual real-world use of these products, such as for the treatment of refractory DFUs.

Kerecis^™ Omega3 for Chronic Deep Dermal Wounds

Kim (2021) reported the results of a retrospective non-randomized controlled study involving of 56 participants with acute or chronic deep dermal wounds who were treated once with Kerecis (n=16) vs. daily standard dressings (n=41). Choice of group was at the participants preference. The control group had 9 participants convert to surgical treatment before the end of the trial, for a total of 32 participants (78%) completing the trial period. In the Kerecis group, 8 participants had acute burns, 5 had acute traumatic wounds, and 1 DFU, 1 VSU and 1 pressure ulcer. In the control group, 15 participants had acute burns, 11 had acute traumatic wounds, and 6 had other unspecified wounds. In the Kerecis group, it was reported that the graft was fully absorbed at an average of 5.56 ± 1.60 days following application, with an average healing rate of 77.7% at 2 weeks. There were no significant differences in wound healing rates between groups for participants with traumatic wounds. For burn participants, the mean healing rate was 86.5% in the Kerecis group vs. 61.1% in the control group (p=0.021). The overall average healing rate of all wound types treated with Kerecis was 77.7% vs. 53.3% for the control group (p<0.05). These results are promising in aggregate, but limited sample sizes limit generalizability, including how Kerecis preforms for certain wound types.

Kerecis^™ Omega3 for Non-healing Wounds

Lee (2024) conducted a single-center, prospective RCT study regarding ischemic hard-to-heal wounds below the knee that were unresponsive to 3 weeks of standard care. The study included participants over 18 with specific wound criteria and vessel impairments. Additional inclusion criteria were having a subcutaneous or deep wound; a wound surface area of 4–250 cm in an ischemic state during wound assessment; showing below-knee vessel impairment by CTA; and demonstrating decreased tissue perfusion, with a transcutaneous oxygen pressure (TcPO2) value of ≤ 40mmHg at the ankle. Participants were randomized into either Kerecis dressing (n=28) or standard dressing (n=22) groups. The outcomes measured were weekly decrease in wound area over 12 weeks, and the number of participants that achieved complete wound closure. The findings demonstrated that in participants with DFUs and wounds predominantly on the foot and pretibial area, the Kerecis dressing led to a more rapid decrease in wound area compared to the standard dressing. Additionally, complete wound healing was greater in the Kerecis group (82%) compared to the standard group (45%). In severe ischemic wounds with TcPO2 < 32mmHg, the Kerecis group re-epithelialization rates were 80.24% compared to 57.44%, respectively. The authors concluded that application of Kerecis is a promising treatment option for lower-extremity hard-to-heal wounds, particularly those with impaired vascularity. However, the study's small sample size and limit its generalizability. Large-scale studies are needed to confirm these findings and further investigate the use of Kerecis for the treatment of ischemic non-healing wounds.

Oasis for Burns

Additionally, several studies have been published addressing the use of Oasis products for the treatment of burns. The first (Salgado, 2014) involved a total of 5 participants treated with both Oasis and silver-containing cellulose hydrofiber (Aquacel AG) at different burn sites on the same individual. This study reported on the histomorphometric outcomes, which demonstrated favorable results in favor of the Oasis product. Measurement of epithelial maturation within the repair areas were considered significantly more phenotypically structured after 7 days of treatment with Oasis vs. the Aquacel-treated wounds at 7 days (6.2 vs. 3.2, p=0.029). No infections or “irritation” were reported. Both products were naturally expelled in all participants by 7 days. The Vancouver Scar Scale score for vascularity, pigmentation, and pliability indicated more favorable results in the Oasis group (3.6 vs. 7.2, p=0.025). The unblinded nature of the study, in addition to the low power and other methodological weaknesses do not allow generalization of the findings across larger populations.

A retrospective unblinded case-control study was reported published by Glik in 2017. This study involved 30 participants with burns treated with either Oasis (n=6) or Suprathel (n=24). Histopathological specimens were harvested for evaluation from the participants at 14 and 21 days. The authors provide qualitative observations of the healing process, including comments regarding product adherence to the wound, progression of epithelialization, and pain levels. However, no quantitative data in these factors were reported. While the authors state that Oasis provides clinical benefit in the treatment of burn wounds, their report is of little value due to the lack of quantitative data to support their findings. Additionally, as with the Salgado study above, significant methodological weaknesses in this study do not allow generalization of the findings across larger populations.

PriMatrix for DFUs

Primatrix is a product derived from acellular bovine dermis and has been cleared through the FDA’s 510K process. To date, there are only a limited number of small studies addressing its use in humans. One retrospective, nonrandomized controlled series involved 68 participants with either DFUs (n=40) or VSUs (n=28) who received treatment with either Apligraf (n=34) or PriMatrix (n=34) (Karr, 2011). The number of participants with each type of wound receiving treatment with Apligraf or PriMatrix was equal, with 20 diabetic foot wounds and 14 VSUs in each group. For diabetic foot ulcers, the Apligraf-treated group’s time to complete healing was 87 days, the PriMatrix was 37 days. The average number of graft applications was 2 in the Apligraf group and 1.5 in the PriMatrix group. For VSUs, the time to complete healing was 63 days in the Apligraf group and 32 days in the PriMatrix group. The Apligraf group had 1.7 graft applications compared to 1.3 in the PriMatrix group.

Lantis and others (2021) reported the results of an unblinded RCT involving 226 participants with treatment resistant DFUs treated with either PriMatrix plus standard care or standard care. The authors state that the study was terminated early due to the COVID-19 pandemic. They conducted a modified intent-to-treat analysis on a total of 207 participants, 103 in the PriMatrix group and 104 in the standard care group. Additionally, a total of 161 participants completed the study per modified protocol, with 79 receiving PriMatrix and 82 standard care. The modified intent-to-treat analysis found that PriMatrix treated participants had a significantly greater number of wounds achieve complete wound closure vs. those treated with standard care (45.6% vs. 27.9%, p=0.008). Similar findings were reported in the modified per-protocol analysis (59.5% vs. 35.4%, p=0.002). The odds of complete wound closure at 12 weeks were reported to be 2.2 times greater in the PriMatrix group (p=0.008). No significant differences were noted with regard to median time to closure within 12 weeks (43 days vs. 57, p=0.36). The mean and median number of PriMatrix applications to achieve closure per wound was 1.4 and 1. No adverse events or serious adverse events related to the use of PriMatrix or the procedure were reported. The authors concluded that a single application of PriMatrix plus standard care offers a safe, faster, and more effective treatment of DFUs than standard care alone.

Strattice

A retrospective case-control study of 80 participants undergoing ventral hernia repair with either Strattice (n=40) or conventional open repair (n=40) was reported by Richmond (2014). Mean follow-up was 33.1 months. The authors reported that the defect size was greater in the Strattice group (mean, 372.5 vs. 283.7 cm², p=0.01) as was the percentage Ventral Hernia Working Group Grade III/IV hernias (65.0% vs. 30.0%, p=0.03). Despite this, the number of recurrences were lower in the Strattice group (13.2% vs. 37.5%, p=0.02), and infection rates were lower as well (0% vs. 23%, respectively, p=0.002). Finally, the indications for reoperation, including recurrence or complications requiring reoperation, were also lower in the Strattice group (17.5% vs. 52.5%, p=0.002).

Huntington (2016) published the results of a retrospective nonrandomized comparative study involving 223 participants who underwent open ventral hernia repair with AlloDerm (n=40), AlloMax (n=23), FlexHD (n=70), Strattice (n=68), or Xenmatrix (n=22). The mean follow-up was 18.2 months. The authors reported the hernia recurrence rate varied significantly by product, with 35% for AlloDerm, 34.5% for AlloMax, 37.1% for FlexHD, 14.7% for Strattice, and 59.1% for Xenmatrix (p=0.001). After multivariate analysis with Strattice as the comparator, AlloMax had a 3.4 higher OR for recurrence, FlexHD a 2.9 OR, and Xenmatrix a 7.8 OR. They concluded that the choice of biologic mesh affects long-term postoperative outcomes in ventral hernia repair, and Strattice had significantly lower odds of hernia recurrence compared with AlloMax, FlexHD, and Xenmatrix.

Also see Clemens, 2013 and Mazari, 2018 in the SurgiMend section below for an additional study involving Strattice.

SurgiMend diaphragmatic and/or chest wall reconstruction

Lampridis, 2023 described the results of a non-randomized comparative study of 66 participants who underwent diaphragmatic and/or chest wall reconstruction for a malignant (74.2%) or benign (25.8%) disease with SurgiMend (n=26, 39.4%) or synthetic expanded polytetrafluoro ethylene mesh (Gore-Tex, n=40, 60.6%). The Gore-Tex group experienced a significantly higher rate of surgical site complications vs. the SurgiMend group (n=6 [37.5%] vs. 2 [11.5%]; p=0.025). Readmission rates were significantly higher in the Gore-Tex group (17.5% vs. 0%; p=0.037), with causes including pleural effusion (n=3), pneumothorax (n=2), empyema (n=1), and pneumonia (n=1). Among the study cohort, only 1 participant with a synthetic mesh underwent reoperation (p>0.99). There were no differences between groups with regard to medical complications or 90-day mortality. This study demonstrates beneficial results with regard to the use of SurgiMend vs. Gore-Tex for diaphragmatic and/or chest wall reconstruction. However, the low power and other methodological issues impair the generalizability of these findings.

510k process: The FDA process used to clear Class I and II medical devices prior to marketing in the U.S. Also referred to as the premarket notification process. This process does not require the review of safety or efficacy data for the products reviewed. Devices considered via this process are deemed “cleared” by the FDA.

Allogeneic: A product derived from humans, other than the individual being treated.

Autologous: A product derived from the individual’s own body or body products.

Bioengineered: A product derived from cultured and processed cells.

Bullous keratopathy: A condition where small fluid-filled vesicles, or bullae, form within the cornea.

Composite: A product derived from a mix of materials of various origins.

Conjunctiva: A clear, thin membrane that covers part of the front of the eye and lines the inside of the eyelids.

Corneal melt: Keratolysis, or sterile melting of the cornea, is a condition characterized by a progressing thinning of the cornea, leading to perforation.

Diabetic foot ulcer (DFU): A potential complication of diabetes due to prolonged elevated blood sugar levels which can damage blood vessels and nerves throughout the body. A DFU is a slow healing full-thickness wound, through the dermis, below the ankle on a weight-bearing or exposed surface in an individual with diabetes. DFUs are categorized as being neuropathic, ischemic, or neuroischemic (mixed). The most common sites are the plantar surface of foot and the toes. DFUs are caused by repetitive injury to an insensate or vascularly compromised foot and may lead to amputation.

Epidermolysis bullosa (EB): A disease characterized by the presence of extremely fragile skin and recurrent blister formation, resulting from minor mechanical friction or trauma.

HCT/P: The FDA’s review process for ‘Human Cells, Tissues, and Cellular and Tissue-Based Products’ human tissue transplantation.

Hernia meshes of non-biologic origin: These products are either synthetic or biosynthetic:

Biosynthetic: Mesh products are made from resorbable synthetically derived meshes with resorption profiles between 6 and 36 months. Theoretically, this allows native collagen deposition for wound strength and durability while reducing the risks of chronic mesh infection affiliated with permanent synthetic alternatives.
Synthetic: Mesh products are made from either woven extruded monofilament (for example, polypropylene or polyester) or created from expanded polytetrafluoroethylene. They may be subcategorized by; weight/density, material, composition, pore characteristics, and mechanical parameters. Products in this category are permanent and are not absorbed by the body.

Humanitarian Device Exemption (HDE): This an FDA pathway for devices intended to treat or diagnose a disease or condition that affects fewer than 4,000 people per year and such conditions purportedly make it difficult to gather enough clinical evidence to meet the FDA standards for other pathways. Applicants must demonstrate that there are no similar, legally approved devices on the market and that there is no other way to bring a Humanitarian Use Device to market. The law exempts HDE devices from demonstrating a reasonable assurance of effectiveness, and instead requires demonstration of probable benefit, and is subject to certain profit and use restrictions. HDE devices must be used only with prior approval and strict observation of an Institutional Review Board (IRB) or appropriate local committee serving a similar function.

Limbal stem cell deficiency: A condition characterized by decreasing function of the stem cells within the epithelial layer of the cornea.

Neurotrophic keratitis: A degenerative disease of the eye due to a loss of corneal sensation leading to progressive damage to the top layer of the cornea.

Penetrating keratoplasty: A surgical procedure that is conducted during corneal transplantation.

Plant based: A product derived from plant sources.

Premarket Approval (PMA): The FDA process used to clear Class III medical devices prior to marketing in the U.S. This process requires the review of safety or efficacy data for the products reviewed. Devices considered via this process are deemed “approved” by the FDA.

Pterygium: A growth involving the conjunctiva of the eye that appears as a growth or bump on the side of the eye near the nose.

Stevens-Johnson syndrome: Also known as toxic epidermal necrolysis, is a rare, serious disorder of the skin and mucous membranes that is characterized by painful rash in its mild form and severe blisters and skin peeling in its more advanced form.

Superficial punctate keratitis (SPK): An inflammation of the upper layers of the cornea with white opacities present below the surface of the cornea, a characteristic negative fluorescein staining pattern may be present. Symptoms include recurrent burning, tearing, light sensitivity, and a sensation of a foreign body in the eyes. Symptoms are usually self-limiting and can be treated with steroids in severe cases.

Synthetic: A product derived from manufactured materials.

Vancouver scar scale: An objective and validated method for describing burn scars that includes a summation of scar characteristics including pigmentation [0-2], vascularity [0-3], pliability [0-5], and height [0-3], normal skin is given a score of 0 for each category.

WHCRA: The Women’s Health and Cancer Rights Act of 1998 (WHCRA) is federal legislation that provides that any individual, with insurance coverage who is receiving benefits in connection with a mastectomy covered by their benefit plan (whether or not for cancer) who elects breast reconstruction, must receive coverage for the reconstructive services as provided by WHCRA. This includes reconstruction of the breast on which the mastectomy has been performed, surgery and reconstruction of the other breast to produce a symmetrical appearance and prostheses and treatment of physical complications of all stages of the mastectomy including lymphedemas. If additional surgery is required for either breast for treatment of physical complications of the implant or reconstruction, surgery on the other breast to produce a symmetrical appearance is reconstructive at that point as well. The name of this law is misleading because: 1) cancer does not have to be the reason for the mastectomy; and 2) the mandate applies to men, as well as women. WHCRA does not address lumpectomies. Some states have enacted similar legislation, and some states include mandated benefits for reconstructive services after lumpectomy.

Xenographic: A product derived from non-human organisms (e.g., cows, pigs, horses, etc.).

Peer Reviewed Publications:

Non-Product Specific Acellular Dermal Matrix (ADM) Studies, Multiple Product Studies, Meta-analyses, and Systematic Reviews

1. Chen AC-Y, Lu Y, Hsieh C-Y, et al. Advanced biomaterials and topical medications for treating diabetic foot ulcers: a systematic review and network meta-analysis. Advances in Wound Care. 2024; 13(2):97-113.
2. Clark RC, Reese MD, Attalla P, et al. A systematic review and meta-analysis of synthetic mesh outcomes in alloplastic breast reconstruction. Aesthet Surg J Open Forum. 2024; 6:ojae066.
3. Haug V, Tapking C, Panayi AC, et al. Outcome comparison of the most commonly employed wound coverage techniques in patients with massive burns ≥50% TBSA - A systematic review and meta-analysis. Burns : journal of the International Society for Burn Injuries. 2024; 50(9):107210.
4. Ho G, Nguyen TJ, Shahabi A, et al. A systematic review and meta-analysis of complications associated with acellular dermal matrix-assisted breast reconstruction. Ann Plast Surg. 2012; 68(4):346-356.
5. Hu Y, Diao W, Wen S, et al. The usage of mesh and relevant prognosis in implant breast reconstruction surgery: a meta-analysis. Aesthetic Plast Surg. 2024; 48(17):3386-3399.
6. Ibrahim AM, Shuster M, Koolen PG, et al. Analysis of the National Surgical Quality Improvement Program database in 19,100 patients undergoing implant-based breast reconstruction: complication rates with acellular dermal matrix. Plast Reconstr Surg. 2013; 132(5):1057-1066.
7. Kim JY, Davila AA, Persing S, et al. A meta-analysis of human acellular dermis and submuscular tissue expander breast reconstruction. Plast Reconstr Surg. 2012; 129(1):28-41.
8. Lee KT, Mun GH. A meta-analysis of studies comparing outcomes of diverse acellular dermal matrices for implant-based breast reconstruction. Ann Plast Surg. 2017; 79(1):115-123.
9. Murphy D, O'Donnell JP, Ryan ÉJ, et al. Immediate breast cancer reconstruction with or without dermal matrix or synthetic mesh support: a review and network meta-analysis. Plast Reconstr Surg. 2023; 151(4):563e-574e.
10. Samuels K, Millet E, Wong L. Efficacy of acellular dermal matrix type in treatment of capsular contracture in breast augmentation: a systematic review and meta-analysis. Aesthet Surg J. 2023; 44(1):26-35.
11. Schnarrs RH, Carman CM, Tobin C, et al. Complication rates with human acellular dermal matrices: retrospective review of 211 consecutive breast reconstructions. Plast Reconstr Surg Glob Open. 2016; 4(11):e1118.
12. Silverstein ML, Momeni A. Long-term outcomes following hybrid breast reconstruction. Plast Reconstr Surg. 2024; 154(2):217e-223e. Epub 2023 Aug 11.
13. Sorkin M, Qi J, Kim HM, et al. Acellular dermal matrix in immediate expander/implant breast reconstruction: a multicenter assessment of risks and benefits. Plast Reconstr Surg. 2017; 140(6):1091-1100.
14. van den Bosch AS, Verwilligen RAF, Pijpe A, et al. Outcomes of dermal substitutes in burns and burn scar reconstruction: A systematic review and meta-analysis. Wound Repair Regen. 2024; 32(6):960-978. Epub 2024 Oct 22.

Allogeneic amniotic membrane-derived grafts or wound coverings used for ophthalmologic indications.

Peer Reviewed Publications:

1. Abdulhalim BE, Wagih MM, Gad AA, et al. Amniotic membrane graft to conjunctival flap in treatment of non-viral resistant infectious keratitis: a randomised clinical study. Br J Ophthalmol. 2015; 99(1):59-63.
2. Arora R, Mehta D, Jain V. Amniotic membrane transplantation in acute chemical burns. Eye. 2005; 19(3):273-278.
3. Asoklis RS, Damijonaityte A, Butkiene L, et al. Ocular surface reconstruction using amniotic membrane following excision of conjunctival and limbal tumors. Eur J Ophthalmol. 2011; 21(5):552-558.
4. Chansanti O, Horatanaruang O. The results of amniotic membrane transplantation for symptomatic bullous keratopathy. J Med Assoc Thai. 2005; 9:S57-62.
5. Chen HC, Tan HY, Hsiao CH, et al. Amniotic membrane transplantation for persistent corneal ulcers and perforations in acute fungal keratitis. Cornea. 2006; 25(5):564-572.
6. Chen HJ, Pires RT, Tseng SC. Amniotic membrane transplantation for severe neurotrophic corneal ulcers. Br J Ophthalmol. 2000; 84(8):826-33.
7. Cheng AM, Zhao D, Chen R, et al. Accelerated restoration of ocular surface health in dry eye disease by self-retained cryopreserved amniotic membrane. Ocul Surf. 2016; 14(1):56-63.
8. Dalla Pozza G, Ghirlando A, Busato F, Midena E. Reconstruction of conjunctiva with amniotic membrane after excision of large conjunctival melanoma: a long-term study. Eur J Ophthalmol. 2005; 15(4):446-450.
9. de Farias CC, Allemann N, Gomes JÁ. Randomized trial comparing amniotic membrane transplantation with lamellar corneal graft for the treatment of corneal thinning. Cornea. 2016; 35(4):438-444.
10. Dekaris I, Mravicić I, Barisić A, et al. Amniotic membrane transplantation in the treatment of persistent epithelial defect on the corneal graft. Coll Antropol. 2010; 34 Suppl 2:15.
11. Espana EM, Grueterich M, Sandoval H, et al. Amniotic membrane transplantation for bullous keratopathy in eyes with poor visual potential. J Cataract Refract Surg. 2003; 29(2):279-784.
12. Georgiadis NS, Ziakas NG, Boboridis KG, et al. Cryopreserved amniotic membrane transplantation for the management of symptomatic bullous keratopathy. Clin Exp Ophthalmol. 2008; 36(2):130-135.
13. Gregory DM. Treatment of acute Stevens-Johnson syndrome and toxic epidermal necrolysis using amniotic membrane: a review of 10 consecutive cases. Ophthalmology. 2011; 118(5):908-914.
14. Gris O, del Campo Z, Wolley-Dod C, et al. Amniotic membrane implantation as a therapeutic contact lens for the treatment of epithelial disorders. Cornea. 2002; 21(1):22-27.
15. Gündüz K, Uçakhan OO, Kanpolat A, Günalp I. Nonpreserved human amniotic membrane transplantation for conjunctival reconstruction after excision of extensive ocular surface neoplasia. Eye (Lond). 2006; 20(3):351-357.
16. Hanada K, Nishikawa N, Miyokawa N, Yoshida A. Long-term outcome of amniotic membrane transplantation combined with mitomycin C for conjunctival reconstruction after ocular surface squamous neoplasia excision. Int Ophthalmol. 2017; 37(1):71-78.
17. Hanada K, Shimazaki J, Shimmura S, Tsubota K. Multilayered amniotic membrane transplantation for severe ulceration of the cornea and sclera. Am J Ophthalmol. 2001; 131(3):324-331
18. Hick S, Demers PE, Brunette I, et al. Amniotic membrane transplantation and fibrin glue in the management of corneal ulcers and perforations: a review of 33 cases. Cornea. 2005; 24(4):369-377
19. Honavar SG, Bansal AK, Rao GN. Amniotic membrane transplantation for ocular surface reconstruction in Stevens-Johnson syndrome. Ophthalmology. 2000; 107(5):975-979.
20. Iveković B, Tedeschi-Reiner E, Petric I, et al. Amniotic membrane transplantation for ocular surface reconstruction in neurotrophic corneal ulcera. Coll Antropol. 2002; 26(1):47-54.
21. John T, Foulks GN, John K. Amniotic membrane in the surgical management of acute toxic epidermal necrolysis. Ophthalmology 2002; 109(2):351-60.
22. John T, Tighe S, Sheha H, et al. Corneal nerve regeneration after self-retained cryopreserved amniotic membrane in dry eye disease. J Ophthalmol. 2017; 2017:6404918.
23. Kheirkhah A, Casas V, Raju VK, Tseng SC. Sutureless amniotic membrane transplantation for partial limbal stem cell deficiency. Am J Ophthalmol. 2008; 145(5):787-794.
24. Kheirkhah A, Johnson DA, Paranjpe DR, et al. Temporary sutureless amniotic membrane patch for acute alkaline burns. Arch Ophthalmol. 2008; 126(8):1059-1066.
25. Khokhar S, Natung T, Sony P, et al. Amniotic membrane transplantation in refractory neurotrophic corneal ulcers: a randomized, controlled clinical trial. Cornea. 2005; 24(6):654-60.
26. Kruse FE, Rohrschneider K, Völcker HE. Multilayer amniotic membrane transplantation for reconstruction of deep corneal ulcers. Ophthalmology. 1999; 106(8):1504-1510.
27. Küçükerdönmez C, Akova YA, Altinörs DD. Comparison of conjunctival autograft with amniotic membrane transplantation for pterygium surgery: surgical and cosmetic outcome. Cornea. 2007; 26(4):407-413.
28. Lee SH, Tseng SC. Amniotic membrane transplantation for persistent epithelial defects with ulceration. Am J Ophthalmol. 1997; 123(3):303-312.
29. Letko E, Stechschulte SU, Kenyon KR, et al. Amniotic membrane inlay and overlay grafting for corneal epithelial defects and stromal ulcers. Arch Ophthalmol. 2001; 119(5):659-663.
30. Lotfy NM, Al Rashidi S, Hagras SM. Clinical outcomes of vacuum-dehydrated amniotic membrane (Omnigen) mounted on contact lens (Omnilenz) in eyes with acute chemical eye injuries. Graefes Arch Clin Exp Ophthalmol. 2023; 261(12):3541-3547.
31. Luanratanakorn P, Ratanapakorn T, Suwan-Apichon O, Chuck RS. Randomised controlled study of conjunctival autograft versus amniotic membrane graft in pterygium excision. Br J Ophthalmol. 2006; 90(12):1476-1480
32. McDonald MB, Sheha H, Tighe S, et al. Treatment outcomes in the Dry Eye Amniotic Membrane (DREAM) study. Clin Ophthalmol. 2018; 12:677-681.
33. Meller D, Pires RT, Mack RJ, et al. Amniotic membrane transplantation for acute chemical or thermal burns. Ophthalmology. 2000; 107(5):980-989.
34. Munster AM, Smith-Meek M, Shalom A. Acellular allograft dermal matrix: immediate or delayed epidermal coverage? Burns. 2001 ;27(2):150-153
35. Paridaens D, Beekhuis H, van Den Bosch W, et al. Amniotic membrane transplantation in the management of conjunctival malignant melanoma and primary acquired melanosis with atypia. Br J Ophthalmol. 2001; 85(6):658-661.
36. Paris F dos S, Gonçalves ED, Campos MS, et al. Amniotic membrane transplantation versus anterior stromal puncture in bullous keratopathy: a comparative study. Br J Ophthalmol. 2013; 97(8):980-984.
37. Pires RT, Tseng SC, Prabhasawat P, et al. Amniotic membrane transplantation for symptomatic bullous keratopathy. Arch Ophthalmol. 1999; 117(10):1291-1297.
38. Prabhasawat P, Barton K, Tseng SCG. Comparison of conjunctival autografts, amniotic membrane grafts, and primary closure for pterygium excision. Ophthalmology. 1997; 104(6):974-985.
39. Prabhasawat P, Tesavibul N, Komolsuradej W. Single and multilayer amniotic membrane transplantation for persistent corneal epithelial defect with and without stromal thinning and perforation. Br J Ophthalmol. 2001; 85:1455-1466.
40. Prabhasawat P, Tesavibul N, Prakairungthong N, Booranapong W. Efficacy of amniotic membrane patching for acute chemical and thermal ocular burns. J Med Assoc Thai. 2007; 90:319-326.
41. Rodríguez-Ares MT, Touriño R, López-Valladares MJ, Gude F. Multilayer amniotic membrane transplantation in the treatment of corneal perforations. Cornea. 2004; 23(6):577-583.
42. Sangwan VS, Matalia HP, Vemuganti GK, Rao GN. Amniotic membrane transplantation for reconstruction of corneal epithelial surface in cases of partial limbal stem cell deficiency. Indian J Ophthalmol. 2004; 52(4):281-285.
43. Seitz B, Das S, Sauer R, et al. Amniotic membrane transplantation for persistent corneal epithelial defects in eyes after penetrating keratoplasty. Eye (London). 2009; 23:840.
44. Shammas MC, Lai EC, Sarkar JS, et al. Management of acute Stevens-Johnson syndrome and toxic epidermal necrolysis utilizing amniotic membrane and topical corticosteroids. Am J Ophthalmol. 2010; 149:203.
45. Sheha H, Liang L, Li J, Tseng SC. Sutureless amniotic membrane transplantation for severe bacterial keratitis. Cornea. 2009; 28(10):1118-1123.
46. Siu GD, Young AL, Cheng LL. Long-term symptomatic relief of bullous keratopathy with amniotic membrane transplant. Int Ophthalmol. 2015; 35:777-783.
47. Solomon A, Meller D, Prabhasawat P, et al. Amniotic membrane grafts for nontraumatic corneal perforations, descemetoceles, and deep ulcers. Ophthalmology. 2002; 109(4):694-703.
48. Srinivas S, Mavrikakis E, Jenkins C. Eur J Ophthalmol. 2007; 17:7-10.
49. Stefaniu GI, Chiotoroiu SM2, Secureanu FA, et al. Use of amniotic membrane in bullous keratopathy palliative care. J Med Life. 2014; 7:88-9.
50. Suri K, Kosker M, Raber IM, et al. Sutureless amniotic membrane ProKera for ocular surface disorders: short-term results. Eye Contact Lens. 2013; 39(5):341-7.
51. Tamhane A, Vajpayee RB, Biswas NR, et al. Evaluation of amniotic membrane transplantation as an adjunct to medical therapy as compared with medical therapy alone in acute ocular burns. Ophthalmology. 2005; 112 (11):1963-1969.
52. Tanaka TS, Demirci H. Cryopreserved ultra-thick human amniotic membrane for conjunctival surface reconstruction after excision of conjunctival tumors. Cornea. 2016; 35(4):445-50.
53. Tananuvat N, Martin T. The results of amniotic membrane transplantation for primary pterygium compared with conjunctival autograft. Cornea. 2004; 23(5):458-463.
54. Tandon R, Gupta N, Kalaivani M, et al. Amniotic membrane transplantation as an adjunct to medical therapy in acute ocular burns. Br J Ophthalmol. 2011; 95(2):199-204.
55. Tejwani S, Kolari RS, Sangwan VS, Rao GN. Role of amniotic membrane graft for ocular chemical and thermal injuries. Cornea. 2007; 26(1):21-26.
56. Travé-Huarte S, Wolffsohn JS. Sutureless dehydrated amniotic membrane (omnigen) application using a specialised bandage contact lens (OmniLenz) for the treatment of dry eye disease: a 6-month randomised control trial. Medicina (Kaunas). 2024; 60(6):985.
57. Tok OY, Tok L, Atay IM, et al. Toxic keratopathy associated with abuse of topical anesthetics and amniotic membrane transplantation for treatment. Int J Ophthalmol. 2015; 18:938-944.
58. Tomlins PJ, Parulekar MV, Rauz S. “Triple-TEN” in the treatment of acute ocular complications from toxic epidermal necrolysis. Cornea. 2013; 32(3):365-369.
59. Tseng SCG, Prabhasawat P, Lee SH. Amniotic membrane transplantation for conjunctival surface reconstruction. Am J Ophthalmol. 1997; 124(6):765-74.
60. Uçakhan OO, Köklü G, Firat E. Nonpreserved human amniotic membrane transplantation in acute and chronic chemical eye injuries. Cornea. 2002; 21(2):169-172.
61. Uhlig CE, Frings C, Rohloff N, et al. Long-term efficacy of glycerine-processed amniotic membrane transplantation in patients with corneal ulcer. Acta Ophthalmol. 2015; 9 3:e481.
62. Westekemper H, Figueiredo FC, Siah WF, et al. Clinical outcomes of amniotic membrane transplantation in the management of acute ocular chemical injury. Br J Ophthalmol. 2017; 101:103-107.

Prokera

1. McDonald MB, Sheha H, Tighe S, et al. Treatment outcomes in the Dry Eye Amniotic Membrane (DREAM) study. Clin Ophthalmol. 2018; 12:677-681.
2. McDonald M, Janik SB, Bowden FW, et al. Association of treatment duration and clinical outcomes in dry eye treatment with sutureless cryopreserved amniotic membrane. Clin Ophthalmol. 2023; 17:2697-2703.
3. Nguyen P, Rue K, Heur M, Yiu SC. Ocular surface rehabilitation: Application of human amniotic membrane in high-risk penetrating keratoplasties. Saudi J Ophthalmol. 2014; 28(3):198-202.
4. Vlasov A, Sia RK, Ryan DS, et al. Sutureless cryopreserved amniotic membrane graft and wound healing after photorefractive keratectomy. J Cataract Refract Surg. 2016; 42(3):435-443.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Clearfield E, Muthappan V, Wang X, Kuo IC. Conjunctival autograft for pterygium. Cochrane Database Syst Rev. 2016;(2):CD011349.
2. Kaufman SC, Jacobs DS, Lee WB, et al. Options and adjuvants in surgery for pterygium: a report by the American Academy of Ophthalmology. Ophthalmology. 2013; 120:201-208.
3. United States Food and Drug Administration (FDA) Products used in implant-based breast reconstruction differ in complication rates: FDA safety communication. March 31, 2021. Available at: https://www.fda.gov/news-events/fda-brief/fda-brief-fda-warns-about-differing-complication-rates-acellular-dermal-matrix-type-surgical-mesh#:~:text=Today%2C%20the%20U.S.%20Food%20and,chance%20for%20complications%20or%20problems. . Accessed on March 19, 2025.

AlloDerm Regenerative Tissue Matrix

1. Fishel Bartal M, Bergh EP, Tsao K, et al. Primary vs patch-based skin closure for in-utero spina bifida repair. Ultrasound Obstet Gynecol. 2022; 60(5):666-672
2. Becker S, Saint-Cyr M, Wong C, et al. AlloDerm versus DermaMatrix in immediate expander-based breast reconstruction: a preliminary comparison of complication profiles and material compliance. Plast Reconstr Surg. 2009; 123(1):1-6.
3. Bindingnavele V, Gaon M, Ota KS, et al. Use of acellular cadaveric dermis and tissue expansion in postmastectomy breast reconstruction. J Plast Reconstr Aesthet Surg. 2007; 60(11):1214-1218.
4. Breuing KH, Colwell AS. Inferolateral AlloDerm hammock for implant coverage in breast reconstruction. Ann Plast Surg. 2007; 59(3):250-255.
5. Breuing KH, Warren SM. Immediate bilateral breast reconstruction with implants and inferolateral AlloDerm slings. Ann Plast Surg. 2005; 55(3):232-239.
6. Diaz JJ Jr, Conquest AM, Ferzoco SJ, et al. Multi-institutional experience using human acellular dermal matrix for ventral hernia repair in a compromised surgical field. Arch Surg. 2009; 144(3):209-215.
7. Diaz JJ Jr, Guy J, Berkes MB, et al. Acellular dermal allograft for ventral hernia repair in the compromised surgical field. Am Surg. 2006; 72(12):1181-1187.
8. Espinosa-de-los-Monteros A, de la Torre JI, Marrero I, et al. Utilization of human cadaveric acellular dermis for abdominal hernia reconstruction. Ann Plast Surg. 2007; 58(3):264-267.
9. Gamboa-Bobadilla GM. Implant breast reconstruction using acellular dermal matrix. Ann Plast Surg. 2006; 56(1):22-25.
10. Glasberg SB, D’Amico RA. Use of regenerative human acellular tissue (AlloDerm) to reconstruct the abdominal wall following pedicle TRAM flap breast reconstruction surgery. Plast Reconstr Surg. 2006; 118(1):8-15.
11. Govindaraj S, Cohen M, Genden EM, et al. The use of acellular dermis in the prevention of Frey’s syndrome. Laryngoscope. 2001; 111(11 Pt 1):1993-1998.
12. Helling ER, Dev VR, Garza J, et al. Low fistula rate in palatal clefts closed with the Furlow technique using decellularized dermis. Plast Reconstr Surg. 2006; 117(7):2361-2365.
13. Kim KY, Woo YJ, Jang SY, et al. Correction of lower eyelid retraction using acellular human dermis during orbital decompression. Ophthalmic Plast Reconstr Surg. 2017 ;33(3):168-172.
14. Lee EI, Chike-Obi CJ, Gonzalez P, et al. Abdominal wall repair using human acellular dermal matrix: a follow-up study. Am J Surg. 2009; 198(5):650-657.
15. Lewis P, Jewell J, Mattison G, et al. Reducing postoperative infections and red breast syndrome in patients with acellular dermal matrix-based breast reconstruction: the relative roles of product sterility and lower body mass index. Ann Plast Surg. 2015; 74(Suppl 1):S30-S32.
16. Lin HJ, Spoerke N, Deveney C, Martindale R. Reconstruction of complex abdominal wall hernias using acellular human dermal matrix: a single institution experience. Am J Surg. 2009; 197(5):599-603.
17. Liu DZ, Mathes DW, Neligan PC, et al. Comparison of outcomes using AlloDerm versus FlexHD for implant-based breast reconstruction. Ann Plast Surg. 2014; 72(5):503-507.
18. Maurice SM, Skeete DA. Use of human acellular dermal matrix for abdominal wall reconstructions. Am J Surg. 2009; 197(1):35-42.
19. Mendenhall SD, Moss WD, Graham EM, et al. The BREASTrial Stage III: Acellular dermal matrix breast reconstruction outcomes from 3 months to 2 years postoperatively. Plast Reconstr Surg. 2023; 151(1):17-24.
20. Michelotti BF, Brooke S, Mesa J, et al. Analysis of clinically significant seroma formation in breast reconstruction using acellular dermal grafts. Ann Plast Surg. 2013; 71(3):274-277.
21. Milstein CF, Akst LM, Hicks MD, et al. Long-term effects of micronized AlloDerm injection for unilateral vocal fold paralysis. Laryngoscope. 2005; 115(9):1691-1696.
22. Misra S, Raj PK, Tarr SM, Treat RC. Results of AlloDerm use in abdominal hernia repair. Hernia. 2008; 12(3):247-250.
23. Nahabedian MY. Secondary nipple reconstruction using local flaps and AlloDerm. Plast Reconstr Surg. 2005; 115(7):2056-2061.
24. Parikh RP, Brown G, Sharma K, et al. Immediate implant-based breast reconstruction with acellular dermal matrix: a comparison of sterile and aseptic AlloDerm in 2039 consecutive cases. Plast Reconstr Surg. 2018; 142(6):1401-1409.
25. Patton JH Jr, Berry S, Kralovich KA. Use of human acellular dermal matrix in complex and contaminated abdominal wall reconstructions. Am J Surg. 2007; 193(3):360-363.
26. Preminger BA, McCarthy CM, Hu QY, et al. The influence of AlloDerm on expander dynamics and complications in the setting of immediate tissue expander/implant reconstruction: a matched-cohort study. Ann Plast Surg. 2008; 60(5):510-513.
27. Salzberg CA. Nonexpansive immediate breast reconstruction using human acellular tissue matrix graft (AlloDerm). Ann Plast Surg. 2006; 57(1):1-5.
28. Sclafani AP, Jacono AA, Dolitsky JN. Grafting of the peritonsillar fossa with an acellular dermal graft to reduce posttonsillectomy pain. Am J Otolaryngol. 2001; 22(6):409-414.
29. Sclafani AP, Romo T 3rd, Jacono AA, et al. Evaluation of acellular dermal graft in sheet (AlloDerm) and injectable (micronized AlloDerm) forms for soft tissue augmentation. Clinical observations and histological analysis. Arch Facial Plast Surg. 2000; 2(2):130-136.
30. Sinha UK, Saadat D, Doherty CM, Rice DH. Use of AlloDerm implant to prevent Frey syndrome after parotidectomy. Arch Facial Plast Surg. 2003; 5(1):109-112.
31. Sinha UK, Shih C, Chang K, Rice DH. Use of AlloDerm for coverage of radial forearm free flap donor site. Laryngoscope. 2002; 112(2):230-234.
32. Spear SL, Parikh PM, Reisin E, Menon NG. Acellular dermis-assisted breast reconstruction. Aesthetic Plast Surg. 2008; 32(3):418-425.
33. Steele MH, Seagle MB. Palatal fistula repair using acellular dermal matrix: the University of Florida experience. Ann Plast Surg. 2006; 56(1):50-53.
34. Sullivan SA, Dailey RA. Graft contraction: a comparison of acellular dermis versus hard palate mucosa in lower eyelid surgery. Ophthal Plast Reconstr Surg. 2003; 19(1):14-24.
35. Vertrees A, Greer L, Pickett C, et al. Modern management of complex open abdominal wounds of war: a 5-year experience. J Am Coll Surg. 2008; 207(6):801-809.
36. Weichman KE, Wilson SC, Weinstein AL, et al. The use of acellular dermal matrix in immediate two-stage tissue expander breast reconstruction. Plast Reconstr Surg. 2012; 129(5):1049-1058.
37. Weichman KE, Wilson SC, Saadeh PB, et al. Sterile “ready-to-use” AlloDerm decreases postoperative infectious complications in patients undergoing immediate implant-based breast reconstruction with acellular dermal matrix. Plast Reconstr Surg. 2013; 132(4):725-736.
38. Woo A, Harless C, Jacobson SR. Revisiting an old place: single-surgeon experience on post-mastectomy subcutaneous implant-based breast reconstruction. Breast J. 2017; 23(5):545-553.

AmnioBand

1. DiDomenico LA, Orgill DP, Galiano RD, et al. Aseptically processed placental membrane improves healing of diabetic foot ulcerations: prospective, randomized clinical trial. Plast Reconstr Surg Glob Open. 2016; 4(10):e1095.
2. DiDomenico LA, Orgill DP, Galiano RD, et al. A retrospective crossover study of the use of aseptically processed placental membrane in the treatment of chronic diabetic foot ulcers. Wounds. 2017; 29(10):311-316.
3. DiDomenico LA, Orgill DP, Galiano RD, et al. Use of an aseptically processed, dehydrated human amnion and chorion membrane improves likelihood and rate of healing in chronic diabetic foot ulcers: A prospective, randomised, multi-centre clinical trial in 80 patients. Int Wound J. 2018; 15(6):950-957.
4. Glat P, Orgill DP, Galiano R, et al. Placental membrane provides improved healing efficacy and lower cost versus a tissue-engineered human skin in the treatment of diabetic foot ulcerations. Plast Reconstr Surg Glob Open. 2019; 7(8):e2371.
5. Serena TE, Orgill DP, Armstrong DG, et al. A multicenter, randomized, controlled, clinical trial evaluating dehydrated human amniotic membrane in the treatment of venous leg ulcers. Plast Reconstr Surg. 2022; 150(5):1128-1136.

Amniotic Allografts – Not specified

1. Abdulhalim BE, Wagih MM, Gad AA, et al. Amniotic membrane graft to conjunctival flap in treatment of non-viral resistant infectious keratitis: a randomised clinical study. Br J Ophthalmol. 2015; 99(1):59-63.
2. Amer MI, Abd-El-Maeboud KH, Abdelfatah I, et al. Human amnion as a temporary biologic barrier after hysteroscopic lysis of severe intrauterine adhesions: pilot study. J Minim Invasive Gynecol. 2010; 17(5):605-611.
3. Andonovska D, Dzokic G, Spasevska L, et al. The advantages of the application of amnion membrane in the treatment of burns. Prilozi. 2008; 29(1):183-198.
4. de Farias CC, Allemann N, Gomes JÁ. Randomized trial comparing amniotic membrane transplantation with lamellar corneal graft for the treatment of corneal thinning. Cornea. 2016; 35(4):438-444.
5. de Farias CC, Sterlenich T, de Sousa LB, et al. Randomized trial comparing multilayer amniotic membrane transplantation with scleral and corneal grafts for the treatment of scleral thinning after pterygium surgery associated with beta therapy. Cornea. 2014; 33(11):1197-204.
6. Georgiadis NS, Ziakas NG, Boboridis KG, et al. Cryopreserved amniotic membrane transplantation for the management of symptomatic bullous keratopathy. Clin Exp Ophthalmol. 2008; 36(2):130-135.
7. Harvinder S, Hassan S, Sidek DS, et al. Underlay myringoplasty: comparison of human amniotic membrane to temporalis fascia graft. Med J Malaysia. 2005; 60(5):585-589.
8. Küçükerdönmez C, Akova YA, Altinörs DD. Vascularization is more delayed in amniotic membrane graft than conjunctival autograft after pterygium excision Am J Ophthalmol. 2007; 143(2):245-249.
9. Luanratanakorn P, Ratanapakorn T, Suwan-Apichon O, Chuck RS. Randomised controlled study of conjunctival autograft versus amniotic membrane graft in pterygium excision. Br J Ophthalmol. 2006; 90(12):1476-1480.
10. Mahdy RA, Nada WM, Almasalamy SM, et al. A freeze-dried (lyophilized) amniotic membrane transplantation with mitomycin C and trabeculectomy for pediatric glaucoma. Cutan Ocul Toxicol. 2010; 29(3):164-170.
11. Paris Fdos S, Gonçalves ED, Campos MS, et al. Amniotic membrane transplantation versus anterior stromal puncture in bullous keratopathy: a comparative study. Br J Ophthalmol. 2013; 97(8):980-984.
12. Sharma N, Thenarasun SA, Kaur M, Pushker N, et al. Adjuvant role of amniotic membrane transplantation in acute ocular Stevens-Johnson syndrome: a randomized control trial. Ophthalmology. 2016; 123(3):484-491.
13. Sheha H, Kheirkhah A, Taha H. Amniotic membrane transplantation in trabeculectomy with mitomycin C for refractory glaucoma J Glaucoma. 2008; 17(4):303-307.
14. Tamhane A, Vajpayee RB, Biswas NR, et al. Evaluation of amniotic membrane transplantation as an adjunct to medical therapy as compared with medical therapy alone in acute ocular burns. Ophthalmology. 2005; 112(11):1963-1969.
15. Tandon R, Gupta N, Kalaivani M, et al. Amniotic membrane transplantation as an adjunct to medical therapy in acute ocular burns. Br J Ophthalmol. 2011; 95(2):199-204.

Apligraf

1. Steinberg JS, Edmonds M, Hurley DP Jr, King WN. Confirmatory data from EU study supports Apligraf for the treatment of neuropathic diabetic foot ulcers. J Am Podiatr Med Assoc. 2010; 100(1):73-77.
2. Veves A, Falanga V, Armstrong DG, Sabolinski ML.; Apligraf Diabetic Foot Ulcer Study. Graftskin, a human skin equivalent, is effective in the management of noninfected neuropathic diabetic foot ulcers: a prospective randomized multicenter clinical trial. Diabetes Care. 2001; 24(2):290-295.
3. Waymack P, Duff RG, Sabolinski M. The effect of a tissue engineered bilayered living skin analog, over meshed split-thickness autografts on the healing of excised burn wounds. The Apligraf Burn Study Group. Burns. 2000; 26(7):609-619. 

Avance

1. Brooks DN, Weber RV, Chao JD, et al. Processed nerve allografts for peripheral nerve reconstruction: a multicenter study of utilization and outcomes in sensory, mixed, and motor nerve reconstructions. Microsurgery. 2012; 32(1):1-14.
2. Ilyas AM, Kirby DJ, Kasper A, et al. Cold intolerance following digital nerve injury: A multicenter prospective randomized comparison of decellularized nerve allograft versus nerve conduits. Hand. 2024:15589447241288252.
3. Means KR Jr, Rinker BD, Higgins JP, et al. A multicenter, prospective, randomized, pilot study of outcomes for digital nerve repair in the hand using hollow conduit compared with processed allograft nerve. Hand (N Y). 2016; 11(2):144-151.
4. Safa B, Jain S, Desai MJ, et al. Peripheral nerve repair throughout the body with processed nerve allografts: results from a large multicenter study. Microsurgery. 2020; 40(5):527-537.

Biobrane

1. Barret JP, Dziewulski P, Ramzy PI, et al. Biobrane versus 1% silver sulfadiazine in second-degree pediatric burns. Plast Reconstr Surg. 2000; 105(1):62-65.
2. Feldman DL, Rogers A, Karpinski RH. A prospective trial comparing Biobrane, Duoderm and xeroform for skin graft donor sites. Surg Gynecol Obstet. 1991; 173(1):1-5.
3. Gerding RL, Emerman CL, Effron D, et al. Outpatient management of partial-thickness burns: Biobrane versus 1% silver sulfadiazine. Ann Emerg Med. 1990; 19(2):121-124.
4. Lal S, Barrow RE, Wolf SE, et al. Biobrane improves wound healing in burned children without increased risk of infection. Shock. 2000; 14(3):314-318.
5. Prasad JK, Feller I, Thomson PD. A prospective controlled trial of Biobrane versus scarlet red on skin graft donor areas. J Burn Care Rehabil. 1987; 8(5):384-386.
6. Rogers AD, Blackport E, Cartotto R. The use of Biobrane^® for wound coverage in Stevens-Johnson Syndrome and toxic epidermal necrolysis. Burns. 2017; 43(7):1464-1472.

Biovance

1. Smiell J, Treadwell T, Hahn H, et al. Real-world experience with a Decellularized Dehydrated Human Amniotic Membrane allograft. Wounds 2015; 27(6):158-169.

Cortiva

1. Keane AM, Chiang SN, Tao Y, et al. Cortiva vs AlloDerm in prepectoral and partial submuscular implant-based breast reconstruction: A randomized clinical trial. Plast Reconstr Surg. Epub: December 12, 2023.
2. Keifer OP, Page EK, Hart A, et al. A Complication analysis of 2 acellular dermal matrices in prosthetic-based breast reconstruction. Plast Reconstr Surg Glob Open. 2016; 4(7):e800.
3. Lindsey JT Jr, Boyd CJ, Davis CB, et al. Alloderm and Cortiva have similar perioperative wound complications in abdominal wall reconstruction. J Surg Res. 2020; 255:255-260.
4. Moyer HR, Hart AM, Yeager J, Losken A. A histological comparison of two human acellular dermal matrix products in prosthetic-based breast reconstruction. Plast Reconstr Surg Glob Open. 2017; 5(12):e1576.
5. Parikh RP, Tenenbaum MM, Yan Y, Myckatyn TM. Cortiva versus AlloDerm Ready-To-Use in prepectoral and submuscular breast reconstruction: prospective randomized clinical trial study design and early findings. Plast Reconstr Surg Glob Open. 2018; 6(11):e2013.
6. Urquia LN, Hart AM, Liu DZ, Losken A. Surgical outcomes in prepectoral breast reconstruction. Plast Reconstr Surg Glob Open. 2020; 8(4):e2744.

DermACELL

1. Bullocks JM. DermACELL: a novel and biocompatible acellular dermal matrix in tissue expander and implant-based breast reconstruction. Eur J Plast Surg. 2014; 37(10):529-538.
2. Cazzell S, Moyer PM, Samsell B, et al. A prospective, multicenter, single-arm clinical trial for treatment of complex diabetic foot ulcers with deep exposure using acellular dermal matrix. Adv Skin Wound Care. 2019; 32(9):409-415.
3. Cazzell S, Vayser D, Pham H, et al. A randomized clinical trial of a human acellular dermal matrix demonstrated superior healing rates for chronic diabetic foot ulcers over conventional care and an active acellular dermal matrix comparator. Wound Repair Regen. 2017; 25(3):483-497.
4. Chang EI, Liu J. Prospective unbiased experience with three acellular dermal matrices in breast reconstruction. J Surg Oncol. 2017; 116(3):365-370.
5. Davison SP, Harbour S, Fassihi E. Comparison of different acellular dermal matrix in breast reconstruction: a skin-to-skin study. Aesthet Surg J. 2024; 44(8):829-837.
6. Ortiz JA. Clinical outcomes in breast reconstruction patients using a sterile acellular dermal matrix allograft. Aesthetic Plast Surg. 2017; 41(3):542-550.
7. Pittman TA, Fan KL, Knapp A, et al. Comparison of different acellular dermal matrices in breast reconstruction: the 50/50 study. Plast Reconstr Surg. 2017; 139(3):521-528.
8. Powers JM, Reuter Muñoz KD, Parkerson J, et al. From salvage to prevention: a single-surgeon experience with acellular dermal matrix and infection in prepectoral breast reconstruction. Plast Reconstr Surg. 2021; 148(6):1201-1208.
9. Walters J, Cazzell S, Pham H, et al. Healing rates in a multicenter assessment of a sterile, room temperature, acellular dermal matrix versus conventional care wound management and an active comparator in the treatment of full-thickness diabetic foot ulcers. Eplasty. 2016; 16:e10.
10. Yonehiro L, Burleson G, Sauer V. Use of a new acellular dermal matrix for treatment of nonhealing wounds in the lower extremities of patients with diabetes. Wounds. 2013; 25(12):340-344.
11. Zenn MR, Salzberg CA. A direct comparison of AlloDerm-Ready to Use (RTU) and DermACELL in immediate breast implant reconstruction. Eplasty. 2016; 16:e23.

Dermagraft

1. Gentzkow GD, Iwasaki SD, Hershon KS, et al. Use of Dermagraft, a cultured human dermis, to treat diabetic foot ulcers. Diabetes Care. 1996; 19(4):350-354.
2. Harding K, Sumner M, Cardinal M. A prospective, multicentre, randomised controlled study of human fibroblast-derived dermal substitute (Dermagraft) in patients with venous leg ulcers. Int Wound J. 2013; 10(2):132-137.
3. Marston WA, Hanft J, Norwood P, et al. The efficacy and safety of Dermagraft in improving the healing of chronic diabetic foot ulcers: results of a prospective randomized trial. Diabetes Care. 2003; 26(6):1701-1705.
4. Warriner RA 3^rd, Cardinal M.; TIDE Investigators. Human fibroblast-derived dermal substitute: results from a treatment investigational device exemption (TIDE) study in diabetic foot ulcers. Adv Skin Wound Care. 2011; 24(7):306-311.

DermaMatrix

1. Agarwal JP, Mendenhall SD, Anderson LA, et al. The breast reconstruction evaluation of acellular dermal matrix as a sling trial (BREASTrial): design and methods of a prospective randomized trial. Plast Reconstr Surg. 2015; 135(1):20e-28e.
2. Athavale SM, Phillips S, Mangus B, et al. Complications of AlloDerm and DermaMatrix for parotidectomy reconstruction. Head Neck. 2012; 34(1):88-93.
3. Becker S, Saint-Cyr M, Wong C, et al. AlloDerm versus DermaMatrix in immediate expander-based breast reconstruction: a preliminary comparison of complication profiles and material compliance. Plast Reconstr Surg. 2009; 123(1):1-6.
4. Brooke S, Mesa J, Uluer M, et al. Complications in tissue expander breast reconstruction: a comparison of AlloDerm, DermaMatrix, and FlexHD acellular inferior pole dermal slings. Ann Plast Surg. 2012; 69(4):347-349.
5. Lee KT, Mun GH. A meta-analysis of studies comparing outcomes of diverse acellular dermal matrices for implant-based breast reconstruction. Ann Plast Surg. 2017; 79(1):115-123.
6. Mendenhall SD, Anderson LA, Ying J, et al. The BREASTrial: stage I. Outcomes from the time of tissue expander and acellular dermal matrix placement to definitive reconstruction. Plast Reconstr Surg. 2015; 135(1):29e-42e.
7. Mendenhall SD, Anderson LA, Ying J, et al. The BREASTrial Stage II: ADM breast reconstruction outcomes from definitive reconstruction to 3 months postoperative. Plast Reconstr Surg Glob Open. 2017; 5(1):e1209.
8. Michelotti BF, Brooke S, Mesa J, et al. Analysis of clinically significant seroma formation in breast reconstruction using acellular dermal grafts. Ann Plast Surg. 2013; 71(3):274-277.

Epicel

1. Carsin H, Ainaud P, Le Bever H, et al. Cultured epithelial autografts in extensive burn coverage of severely traumatized patients: a five year single-center experience with 30 patients. Burns. 2000; 26 (379-387).
2. Hickerson W. Twenty-five years’ experience and beyond with cultured epidermal autografts for coverage of large burn wounds in adult and pediatric patients, 1989–2015. J Burn Care Res. 2019; 40(2):157-165.

EpiCord

1. Tettelbach W, Cazzell S, Sigal F, et al. A multicentre prospective randomised controlled comparative parallel study of dehydrated human umbilical cord (EpiCord) allograft for the treatment of diabetic foot ulcers. Int Wound J. 2018; 16(1):122-130.

EpiFix

1. Adly OA, Moghazy AM, Abbas AH, et al. Assessment of amniotic and polyurethane membrane dressings in the treatment of burns. Burns. 2010; 36(5):703-710.
2. Bianchi C, Cazzell S, Vayser D, et al. A multicentre randomised controlled trial evaluating the efficacy of dehydrated human amnion/chorion membrane (EpiFix^®) allograft for the treatment of venous leg ulcers. Int Wound J. 2018; 15(1):114-122.
3. Branski LK, Herndon DN, Celis MM, et al. Amnion in the treatment of pediatric partial-thickness facial burns. Burns. 2008; 34(3):393-399.
4. Forbes J, Fetterolf DE. Dehydrated amniotic membrane allografts for the treatment of chronic wounds: a case series. J Wound Care. 2012; 21(6):290, 292, 294-296.
5. Mostaque AK, Rahman KB. Comparisons of the effects of biological membrane (amnion) and silver sulfadiazine in the management of burn wounds in children. J Burn Care Res. 2011; 32(2):200-209.
6. Patel VR, Samavedi S, Bates AS, et al. Dehydrated human amnion/chorion membrane allograft nerve wrap around the prostatic neurovascular bundle accelerates early return to continence and potency following robot-assisted radical prostatectomy: propensity score-matched analysis. Eur Urol. 2015; 67(6):977-980.
7. Serena TE, Carter MJ, Le LT, et al.; EpiFix VLU Study Group. A multi-center randomized controlled clinical trial evaluating the use of dehydrated human amnion/chorion membrane allografts and multilayer compression therapy vs. multilayer compression therapy alone in the treatment of venous leg ulcers. Wound Repair Regen. 2014; 22(6):688-693.
8. Sheikh ES, Sheikh ES, Fetterolf DE. Use of dehydrated human amniotic membrane allografts to promote healing in patients with refractory non healing wounds. Int Wound J. 2014; 11(6):711-717.
9. Tamhane A, Vajpayee RB, Biswas NR, et al. Evaluation of amniotic membrane transplantation as an adjunct to medical therapy as compared with medical therapy alone in acute ocular burns. Ophthalmology. 2005; 112(11):1963-1969.
10. Tettelbach W, Cazzell S, Reyzelman AM, et al. A confirmatory study on the efficacy of dehydrated human amnion/chorion membrane dHACM allograft in the management of diabetic foot ulcers: a prospective, multicentre, randomised, controlled study of 110 patients from 14 wound clinics. Int Wound J. 2018; 16(1):19-29.
11. Toman J, Wisco OJ, Adam, JR, et al. Mohs defect repair with dehydrated human amnion/chorion membrane. Facial Plast Surg. 2021; In press.
12. Zelen CM. An evaluation of dehydrated human amniotic membrane allografts in patients with DFUs. J Wound Care. 2013b; 22(7):347-348, 350-351.
13. Zelen CM, Gould L, Serena TE, et al. A prospective, randomised, controlled, multi-centre comparative effectiveness study of healing using dehydrated human amnion/chorion membrane allograft, bioengineered skin substitute or standard of care for treatment of chronic lower extremity diabetic ulcers. Int Wound J. 2014b; 12(6):724-732.
14. Zelen CM, Serena TE, Denoziere G, Fetterolf DE. A prospective randomised comparative parallel study of amniotic membrane wound graft in the management of diabetic foot ulcers. Int Wound J. 2013c; 10(5):502-507.
15. Zelen CM, Serena TE, Fetterolf DE. Dehydrated human amnion/chorion membrane allografts in patients with chronic diabetic foot ulcers: a long-term follow-up study. Wound Medicine. 2014a; 4:1-4.
16. Zelen CM, Serena TE, Gould L, et al. Treatment of chronic diabetic lower extremity ulcers with advanced therapies: a prospective, randomised, controlled, multi-centre comparative study examining clinical efficacy and cost. Int Wound J. 2016a; 13(2):272-282.

E-Z Derm

1. Burkey B, Davis W 3^rd, Glat PM. Porcine xenograft treatment of superficial partial-thickness burns in paediatric patients. J Wound Care. 2016; 25(2):S10-15.
2. Healy CM, Boorman JG. Comparison of E-Z Derm and Jelonet dressings for partial skin thickness burns. Burns Incl Therm Inj. 1989; 15(1):52-54.
3. Troy J, Karlnoski R, Downes K, et al. The use of EZ Derm^® in partial-thickness burns: an institutional review of 157 patients. Eplasty. 2013; 13:e14.
4. Vanstraelen P. Comparison of calcium sodium alginate (KALTOSTAT) and porcine xenograft (E-Z DERM) in the healing of split-thickness skin graft donor sites. Burns. 1992; 18(2):145-148.

FlexHD

1. Bochicchio GV, De Castro GP, Bochicchio KM, et al. Comparison study of acellular dermal matrices in complicated hernia surgery. J Am Coll Surg. 2013; 217(4):606-613.
2. Brooke A, Mesa J, Uluer M, et al. Complications in tissue expander breast reconstruction: a comparison of AlloDerm, DermaMatrix, and FlexHD acellular inferior pole dermal slings. Ann Plast Surg. 2012; 69(4):347-349.
3. Broyles JM, Liao EC, Kim J, et al. Acellular dermal matrix-associated complications in implant-based breast reconstruction: a multicenter, prospective, randomized controlled clinical trial comparing two human tissues. Plast Reconstr Surg. 2021; 148(3):493-500.
4. Cahan AC, Palaia DA, Rosenberg M, Bonanno PC. The aesthetic mastectomy utilizing a non-nipple-sparing portal approach. Ann Plast Surg. 2011; 66(5):424-428.
5. Liu DZ, Mathes DW, Neligan PC, et al. Comparison of outcomes using AlloDerm versus FlexHD for implant-based breast reconstruction. Ann Plast Surg. 2014; 72(5):503-507.
6. Michelotti BF, Brooke S, Mesa J, et al. Analysis of clinically significant seroma formation in breast reconstruction using acellular dermal grafts. Ann Plast Surg. 2013; 71(3):274-277.
7. Palaia DA, Arthur KS, Cahan AC, Rosenberg MH. Incidence of seromas and infections using fenestrated versus nonfenestrated acellular dermal matrix in breast reconstructions. Plast Reconstr Surg Glob Open. 2015; 3(11):e569.
8. Rawlani V, Buck DW 2^nd, Johnson SA, et al. Tissue expander breast reconstruction using prehydrated human acellular dermis. Ann Plast Surg. 2011; 66(6):593-597.
9. Seth AK, Hirsch EM, Fine NA, Kim JY. Utility of acellular dermis-assisted breast reconstruction in the setting of radiation: a comparative analysis. Plast Reconstr Surg. 2012; 130(4):750-758.
10. Seth AK, Persing S, Connor CM, et al. A comparative analysis of cryopreserved versus prehydrated human acellular dermal matrices in tissue expander breast reconstruction. Ann Plast Surg. 2013; 70(6):632-635.
11. Sobti N, Liao EC. Surgeon-controlled study and meta-analysis comparing FlexHD and AlloDerm in immediate breast reconstruction outcomes. Plast Reconstr Surg. 2016; 138(5):959-967.
12. Vu MM, De Oliveira GS Jr, Mayer KE, et al. A prospective study assessing complication rates and patient-reported outcomes in breast reconstructions using a novel, deep dermal human acellular dermal matrix. Plast Reconstr Surg Glob Open. 2016; 3(12):e585.

Grafix PRIME

1. Ananian CE, Dhillon YS, Van Gils CC, et al. A multicenter, randomized, single-blind trial comparing the efficacy of viable cryopreserved placental membrane to human fibroblast-derived dermal substitute for the treatment of chronic diabetic foot ulcers. Wound Repair Regen. 2018; 26(3):274-283.
2. Johnson EL, Marshall JT, Michael GM. A comparative outcomes analysis evaluating clinical effectiveness in two different human placental membrane products for wound management. Wound Repair Regen. 2017; 25(1):145-149.
3. Lavery LA, Fulmer J, Shebetka KA, et al.; Grafix Diabetic Foot Ulcer Study Group. The efficacy and safety of Grafix(^®) for the treatment of chronic diabetic foot ulcers: results of a multi-centre, controlled, randomised, blinded, clinical trial. Int Wound J. 2014; 11(5):554-560.
4. Lavery L, Fulmer J, Shebetka KA, et al. Open-label extension phase of a chronic diabetic foot ulcer multicenter, controlled, randomized clinical trial using cryopreserved placental membrane. Wounds. 2018; 30(9):283-289.
5. Raspovic KM, Wukich DK, Naiman DQ, et al. Effectiveness of viable cryopreserved placental membranes for management of diabetic foot ulcers in a real world setting. Wound Repair Regen. 2018; 26(2):213-220.
6. Regulski M, Jacobstein DA, Petranto RD, et al. A retrospective analysis of a human cellular repair matrix for the treatment of chronic wounds. Ostomy Wound Manage. 2013; 59(12):38-43.

GrafixPL PRIME

1. Davis KE, Killeen AL, Farrar D, et al. Lyopreserved amniotic membrane is cellularly and clinically similar to cryopreserved construct for treating foot ulcers. Int Wound J. 2020; 17(6):1893-1901.

GraftJacket

1. Barber FA, Burns JP, Deutsch A, et al. A prospective, randomized evaluation of acellular human dermal matrix augmentation for arthroscopic rotator cuff repair. Arthroscopy. 2012; 28(1):8-15.
2. Brigido SA, Boc SF, Lopez RC. Effective management of major lower extremity wounds using an acellular regenerative tissue matrix: a pilot study. Orthopedics. 2004; 27(1 Suppl):s145-149.
3. Brigido SA. The use of an acellular dermal regenerative tissue matrix in the treatment of lower extremity wounds: a prospective 16-week pilot study. Int Wound J. 2006; 3(3):181-187.
4. Cazzell S, Vayser D, Pham H, et al. A randomized clinical trial of a human acellular dermal matrix demonstrated superior healing rates for chronic diabetic foot ulcers over conventional care and an active acellular dermal matrix comparator. Wound Repair Regen. 2017; 25(3):483-497.
5. Gupta AK, Hug K, Berkoff DJ, et al. Dermal tissue allograft for the repair of massive irreparable rotator cuff tears. Am J Sports Med. 2012; 40(1):141-147.
6. Marks M, Hensler S, Wehrli M, et al. Trapeziectomy with suspension-interposition arthroplasty for thumb carpometacarpal osteoarthritis: a randomized controlled trial comparing the use of Allograft versus flexor carpi radialis tendon. J Hand Surg Am. 2017; 42(12):978-986.
7. Martin BR, Sangalang M, Wu S, Armstrong DG. Outcomes of allogenic acellular matrix therapy in treatment of diabetic foot wounds: an initial experience. Int Wound J. 2005; 2(2):161-165.
8. Reyzelman A, Crews RT, Moore JC, et al. Clinical effectiveness of an acellular dermal regenerative tissue matrix compared to standard wound management in healing diabetic foot ulcers: a prospective, randomised, multicentre study. Int Wound J. 2009; 6(3):196-208.
9. Walters J, Cazzell S, Pham H, et al. Healing rates in a multicenter assessment of a sterile, room temperature, acellular dermal matrix versus conventional care wound management and an active comparator in the treatment of full-thickness diabetic foot ulcers. Eplasty. 2016; 16:e10.

Integra Bilayer Matrix Wound Dressing

1. Branski LK, Herndon DN, Pereira C, et al. Longitudinal assessment of Integra in primary burn management: a randomized pediatric clinical trial. Crit Care Med. 2007; 35(11):2615-2623.
2. Heimbach DM, Warden GD, Luterman A, et al Multicenter postapproval clinical trial of Integra dermal regeneration template for burn treatment. J Burn Care Rehabil. 2003; 24(1):42-8.
3. Othman S, Lukowiak T, Shakir S, et al. Bilayer wound matrix-based cutaneous scalp reconstruction: A multidisciplinary case control analysis of factors associated with reconstructive success and failure. J Plast Reconstr Aesthet Surg. 2021; 74(11):3008-3014.

Integra Omnigraft Dermal Regeneration Template

1. Dantzer E, Braye FM. Reconstructive surgery using an artificial dermis (Integra): results with 39 grafts. Br J Plast Surg. 2001; 54(8):659-664.
2. Driver VR, Lavery LA, Reyzelman AM, et al. A clinical trial of Integra Template for diabetic foot ulcer treatment. Wound Repair Regen. 2015; 23(6):891-900.
3. Falcone M, Preto M, Ciclamini D, et al. Bioengineered dermal matrix (Integra®) reduces donor site morbidity in total phallic construction with radial artery forearm free-flap. Int J Impot Res. 2023; Oct 17. Epub ahead of print.
4. Heimbach D, Warden G, Luterman A, et al. Multicenter post approval clinical trial of Integra^® Dermal Regeneration Template for burn treatment. J Burn Care Rehabil. 2003; 24:42-48.
5. Hicks CW, Zhang GQ, Canner JK, et al. Outcomes and predictors of wound healing among patients with complex diabetic foot wounds treated with a dermal regeneration template (Integra). Plast Reconstr Surg. 2020; 146(4):893-902.
6. Mogedas-Vegara A, Agut-Busquet E, Yébenes Marsal M, et al. Integra as firstline treatment for scalp reconstruction in elderly patients. J Oral Maxillofac Surg. 2021; 79(12):2593-2602.
7. Ryan C, Schoenfeld D, Malloy M, et al. Use of Integra^® artificial skin is associated with decreased length of stay for severely injured adult burn survivors. J Burn Care Rehabil. 2002; 23:311-317.

Kerecis

1. Baldursson BT, Kjartansson H, Konrádsdóttir F, et al. Healing rate and autoimmune safety of full-thickness wounds treated with fish skin acellular dermal matrix versus porcine small-intestine submucosa: a noninferiority study. Int J Low Extrem Wounds. 2015; 14(1):37-43.
2. Dardari D, Piaggesi A, Potier L, et al. Intact fish skin graft to treat deep diabetic foot ulcers. NEJM Evid. 2024; 3(12):EVIDoa2400171.
3. Freund G, Schäfer B, Beier JP, Boos AM. Individualized surgical treatment using decellularized fish skin transplantation after enzymatic debridement: A two years retrospective analysis. JPRAS Open. 2024; 43:79-91. 
4. Kim TH, Park JH, Jeong HG, Wee SY. The utility of novel fish-skin derived acellular dermal matrix (Kerecis) as a wound dressing material. Wound Manag Res. 2021; 17(1):39-47.
5. Kirsner RS, Margolis DJ, Baldursson BT, et al. Fish skin grafts compared to human amnion/chorion membrane allografts: a double-blind, prospective, randomized clinical trial of acute wound healing. Wound Repair Regen. 2020; 28(1):75-80.
6. Lantis Ii JC, Lullove EJ, Liden B, et al. Final efficacy and cost analysis of a fish skin graft vs standard of care in the management of chronic diabetic foot ulcers: a prospective, multicenter, randomized controlled clinical trial. Wounds. 2023; 35(4):71-79.
7. Lee YJ, Han HJ, Shim HS. Treatment of hard-to-heal wounds in ischaemic lower extremities with a novel fish skin-derived matrix. J Wound Care. 2024; 33(5):348-356.
8. Lullove EJ, Liden B, Winters C, et al. A multicenter, blinded, randomized controlled clinical trial evaluating the effect of omega-3-rich fish skin in the treatment of chronic, nonresponsive diabetic foot ulcers. Wounds. 2021;33(7):169-177.
9. Lullove EJ, Liden B, McEneaney P, et al. Evaluating the effect of omega-3-rich fish skin in the treatment of chronic, nonresponsive diabetic foot ulcers: penultimate analysis of a multicenter, prospective, randomized controlled trial. Wounds. 2022; 34(4): E34-E36.
10. Lullove EJ, Liden B, McEneaney P, et al. Fish-skin grafts for the management of chronic diabetic foot ulcers: final efficacy and cost analysis of a prospective, multicenter, randomized, controlled clinical trial, and cost effectiveness versus a standardized care plan. Wounds. 2023; In press.
11. Michael S, Winters C, Khan M. Acellular fish skin graft use for diabetic lower extremity wound healing: a retrospective study of 58 ulcerations and a literature review. Wounds. 2019; 31(10):262-268.
12. Ruiz-Muñoz M, Martinez-Barrios FJ, Cervera-Garvi P, et al. Fish skin grafts versus standard of care on wound healing of chronic diabetic foot ulcers: A systematic review and meta-analysis. Prim Care Diabetes. 2024; 18(3):291-298.
13. Yang CK, Polanco TO, Lantis JC 2^nd. A prospective, postmarket, compassionate clinical evaluation of a novel acellular fish-skin graft which contains omega-3 fatty acids for the closure of hard-to-heal lower extremity chronic ulcers. Wounds. 2016; 28(4):112-118.

mVASC

1. Gould LJ, Orgill DP, Armstrong DG, et al. Improved healing of chronic diabetic foot wounds in a prospective randomised controlled multi-centre clinical trial with a microvascular tissue allograft. Int Wound J. 2022; 19(4):811-825.

NuShield

1. Cazzell SM, Caporusso J, Vayser D, et al. Amnion Chorion Membrane versus standard of care for diabetic foot ulcers: a randomised controlled trial. J Wound Care. 2024; 33(Sup7):S4-S14.

Oasis

1. Brown-Etris M, Milne CT, Hodde JP. An extracellular matrix graft (Oasis^® wound matrix) for treating full-thickness pressure ulcers: A randomized clinical trial. J Tissue Viability. 2019; 28(1):21-26.
2. Cazzell SM, Lange DL, Dickerson JE Jr, Slade HB. The management of diabetic foot ulcers with porcine small intestine submucosa tri-layer matrix: a randomized controlled trial. Adv Wound Care (New Rochelle). 2015; 4(12):711-718.
3. Glik J, Kawecki M, Kitala D, et al. A new option for definitive burn wound closure pair matching type of retrospective case-control study of hand burns in the hospitalised patients group in the Dr Stanislaw Sakiel Centre for Burn Treatment between 2009 and 2015. Int Wound J. 2017; 14(5):849-855.
4. Martinson M, Martinson N. A comparative analysis of skin substitutes used in the management of diabetic foot ulcers. J Wound Care. 2016; 25(Sup10): S8-S17.
5. Mostow EN, Haraway GD, Dalsing M, et al. Effectiveness of an extracellular matrix graft (Oasis Wound Matrix) in the treatment of chronic leg ulcers: a randomized clinical trial. J Vasc Surg. 2005; 41(5):837-843.
6. Niezgoda JA, Van Gils CC, Frykberg RG, Hodde JP. Randomized clinical trial comparing Oasis Wound Matrix to Regranex Gel for diabetic ulcers. Adv Skin Wound Care. 2005; 18(5 Pt 1):258-266.
7. Romanelli M, Dini V, Bertone M. Randomized comparison of Oasis wound matrix versus moist wound dressing in the treatment of difficult-to-heal wounds of mixed arterial/venous etiology. Adv Skin Wound Care. 2010; 23(1):34-38.
8. Romanelli M, Dini V, Bertone M, et al. Oasis wound matrix versus Hyaloskin in the treatment of difficult-to-heal wounds of mixed arterial/venous aetiology. Int Wound J. 2007; 4(1):3-7.
9. Salgado RM, Bravo L, García M, et al. Histomorphometric analysis of early epithelialization and dermal changes in mid-partial-thickness burn wounds in humans treated with porcine small intestinal submucosa and silver-containing hydrofiber. J Burn Care Res. 2014; 35(5):e330-337.

OviTex

1. DeNoto G 3rd, Ceppa EP, Pacella SJ, et al. 24-Month results of the BRAVO study: a prospective, multi-center study evaluating the clinical outcomes of a ventral hernia cohort treated with OviTex® 1S permanent reinforced tissue matrix. Ann Med Surg (Lond). 2022; 83:104745.
2. Sivaraj D, Fischer KS, Kim TS, et al. Outcomes of biosynthetic and synthetic mesh in ventral hernia repair. Plast Reconstr Surg Glob Open. 2022; 10(12): e4707.
3. Sivaraj D, Henn D, Fischer KS, et al. Reinforced biologic mesh reduces postoperative complications compared to biologic mesh after ventral hernia repair. Plast Reconstr Surg Glob Open. 2022; 10(2): e4083.

Phasix Mesh, Phasix ST Mesh

1. Abdelmoaty WF, Dunst CM, Filicori F, et al. Combination of surgical technique and bioresorbable mesh reinforcement of the crural repair leads to low early hernia recurrence rates with laparoscopic paraesophageal hernia repair. J Gastrointest Surg. 2020; 24(7):1477-1481.
2. Ahmed A, Gandhi S, Ganam S, et al. Ventral hernia repair using bioresorbable poly-4-hydroxybutyrate mesh in clean and contaminated surgical fields: a systematic review and meta-analysis. Hernia. 2024; 28(2):575-584.
3. Buell J, Flaris A, Raju S, et al. Long-term outcomes in complex abdominal wall reconstruction repaired with absorbable biologic polymer scaffold (poly-4-hydroxybutyrate). Ann Surg. 2021; 1(e032):1–7.
4. Bueno-Lledó J, Ceno M, Pérez-Alonso C, et al. Abdominal wall reconstruction with biosynthetic absorbable mesh after infected prosthesis explantation: single stage is better than two-stage approach of chronic mesh infection. Hernia. 2020; 25(4):1005–12.
5. Bueno-Lledó J, Ceno M, Perez-Alonso C, et al. Biosynthetic resorbable prosthesis is useful in single-stage management of chronic mesh infection after abdominal wall hernia repair. World J Surg. 2021; 45(2):443–50.
6. Bueno-Lledó J, Porrero-Guerrero B, Ferreira F, et al. Long-term results with biosynthetic absorbable P4HB mesh in ventral abdominal wall repair: a multicentre analysis. Hernia. 2024 Mar 13. Epub ahead of print.
7. Christopher AN, Morris MP, Patel V, et al. An evaluation of clinical and quality of life outcomes after ventral hernia repair with poly-4-hydroxybutyrate mesh. Hernia. 2021; 25(3):717–26.
8. Christopher AN, Morris MP, Jia H, et al. Resorbable synthetic ventral hernia repair in contaminated fields: outcomes with poly-4 hydroxybutyrate mesh. Plast Reconstr Surg. 2021; 148(6):1367–75.
9. Christopher AN, Patel V, Othman S, et al. Onlay poly-4-hydroxybutyrate (P4HB) mesh for complex hernia: early clinical and patient reported outcomes. J Surg Res. 2021; 264:199–207.
10. Claessen JJM, Timmer AS, Atema JJ, et al. Outcomes of mid-term and long-term degradable biosynthetic meshes in single-stage open complex abdominal wall reconstruction. Hernia. 2021; 26:1–11.
11. Fowler CC, Klifto KM, Wietlisbach LE, et al. Poly-4-hydroxybutyrate mesh for Ventral Hernia Repairs: a single-surgeon experience. Eplasty. 2023 Aug 17;23:e48.
12. Levy AS, Bernstein JL, Premaratne ID, et al. Poly-4-hydroxybutyrate (phasixTM) mesh onlay in complex abdominal wall repair. Surg Endosc. 2021; 35(5):2049–58.
13. Messa CA, Kozak G, Broach RB, et al. When the mesh goes away: an analysis of poly-4-hydroxybutyrate mesh for complex hernia repair. Plast Reconstr Surg Glob Open. 2019; 7(11):e2576.
14. Messa CA, Amro C, Niu EF, et al. Transversus abdominis release with biosynthetic mesh for large ventral hernia repair: a 5-year analysis of clinical outcomes and quality of life. Hernia. 2023 Sep 27. Epub ahead of print.
15. Morales-Conde S, Hernández-Granados P, Tallón-Aguilar L, et al. Ventral hernia repair in high-risk patients and contaminated fields using a single mesh: proportional meta-analysis. Hernia. 2022; 26(6):1459-1471.
16. Morrison BG, Gledhill K, Plymale MA, Davenport DL, et al. Comparative long-term effectiveness between ventral hernia repairs with biosynthetic and synthetic mesh. Surg Endosc. 2023; 37(8):6044-6050.Perrone G, Giuffrida M, Bonati E, Petracca GL, et al. Biosynthetic meshes in contaminated fields: where are we now? A systematic review and meta-analysis in humans. Hernia. 2023; 27(4):765-780.
17. Pakula A, Skinner R. Outcomes of open complex ventral hernia repairs with retromuscular placement of poly-4 hydroxybutyrate bioabsorbable mesh. Surg Innov. 2020; 27(1):32–7.
18. Perrone G, Giuffrida M, Bonati E, Petracca GL, et al. Biosynthetic meshes in contaminated fields: where are we now? A systematic review and meta-analysis in humans. Hernia. 2023; 27(4):765-780.
19. Roth JS, Anthone GJ, Selzer DJ, et al. Longterm, prospective, multicenter study of P4HB (phasixTM) mesh for hernia repair in cohort at risk for complications: 60-months follow-up. J Am Coll Surg. 2022; 1:894–904.
20. Roth JS, Anthone GJ, Selzer DJ, et al. Prospective, multicenter study of P4HB (phasix) mesh for hernia repair in cohort at risk for complications: 3-year follow-up. Ann Med Surg (Lond). 2020; 61:1–7.
21. Schecter SC, Imhoff L, Lasker MV, et al. Single-stage abdominal wall reconstruction in contaminated and dirty wounds is safe: a single center experience. Surg Endosc. 2022; 36(8):5766–71.
22. Tran DH, Rubarth C, Leeds SG, et al. The use of poly-4-hydroxybutyrate (P4HB, Phasix™) mesh in ventral hernia repair: a systematic review and meta-analysis. Hernia. 2024 Mar 21. Epub ahead of print.
23. Van den Dop LM, Van Rooijen MMJ, Tollens T, et al. Five-Year follow-up of a slowly resorbable biosynthetic P4HB Mesh (Phasix) in VHWG Grade 3 incisional hernia repair. Ann Surg Open. 2023; 4(4):e366.
24. van Rooijen MMJ, Tollens T, Jorgensen LN, et al. Slowly resorbable biosynthetic mesh: 2-year results in VHWG grade 3 hernia repair. Hernia. 2021; 26(1):131–8.
25. van Rooijen MMJ, Jairam AP, Tollens T, et al. Outcomes of a new slowly resorbable biosynthetic mesh (phasixTM) in potentially contaminated incisional hernias: a prospective, multicenter, single-arm trial. Int J Surg. 2020; 83:31–6.
26. Vauclair E, Bert M, Facy O, et al. What results can be expected one year after complex incisional hernia repair with biosyntheticmesh? J Vasc Surg. 2021; 158(2):111–7.
27. Wagner V, Levy BE, Castle JT, et al. Absorbable mesh in a contaminated field: hernia repair outcomes. Updates Surg. 2023; 75(5):1337-1342.

PriMatrix

1. Karr JC. Retrospective comparison of diabetic foot ulcer and venous stasis ulcer healing outcome between a dermal repair scaffold (PriMatrix) and a bilayered living cell therapy (Apligraf). Adv Skin Wound Care. 2011; 24(3):119-125.
2. Kavros SJ. Acellular fetal bovine dermal matrix for treatment of chronic ulcerations of the midfoot associated with Charcot neuroarthropathy. Foot Ankle Spec. 2012; 5(4):230-234.
3. Lantis JC, Snyder R, Reyzelman AM, et al.; PriMatrix Study Group. Fetal bovine acellular dermal matrix for the closure of diabetic foot ulcers: a prospective randomised controlled trial. J Wound Care. 2021; 30(Sup7):S18-S27.

ReCell

1. Holmes IV JH, Molnar JA, Carter JE, et al. A comparative study of the ReCell® device and autologous split -thickness meshed skin graft in the treatment of acute burn injuries. J Burn Care Res. 2018; 39(5):694-702.
2. Holmes JH 4th, Molnar JA, Shupp JW, et al. Demonstration of the safety and effectiveness of the RECELL^® System combined with split-thickness meshed autografts for the reduction of donor skin to treat mixed-depth burn injuries. Burns. 2019; 45(4):772-782.
3. Wala SJ, Patterson K, Scoville S, et al. A single institution case series of ReCell^® use in treating pediatric burns. Int J Burns Trauma. 2023; 13(2):78-88.

Repriza

See Solomon (2013) above

SimpliDerm

1. Tierney BP. Comparison of 30-day clinical outcomes with SimpliDerm and AlloDerm RTU in immediate breast reconstruction. Plast Reconstr Surg Glob Open. 2021; 9(6): e3648.
2. Tierney B P, De La Garza M, Jennings G R, et al. Clinical outcomes of acellular dermal matrix (SimpliDerm and AlloDerm Ready-to-Use) in immediate breast reconstruction. Cureus. 2022; 14(2): e22371.

StrataGraft

1. Gibson ALF, Holmes JH 4th, Shupp JW, et al. A phase 3, open-label, controlled, randomized, multicenter trial evaluating the efficacy and safety of StrataGraft^® construct in patients with deep partial-thickness thermal burns. Burns. 2021; 47(5):1024-1037
2. Holmes JH 4th, Schurr MJ, King BT, et al. An open-label, prospective, randomized, controlled, multicenter, phase 1b study of StrataGraft skin tissue versus autografting in patients with deep partial-thickness thermal burns. Burns. 2019; pii: S0305-4179(19)30432-2.
3. Holmes Iv JH, Cancio LC, Carter JE, et al. Pooled safety analysis of STRATA2011 and STRATA2016 clinical trials evaluating the use of StrataGraft® in patients with deep partial-thickness thermal burns. Burns. 2022; 48(8):1816-1824.
4. Holmes Iv JH, Gibson ALF, Short T, et al. A phase 3b, open-label, single-arm, multicenter, expanded-access study of the safety and clinical outcomes of StrataGraft® treatment in adults with deep partial-thickness thermal burns. Burns. 2024; 50(8):2013-2022.
5. Schurr MJ, Foster KN, Centanni JM, et al. Phase I/II clinical evaluation of StrataGraft: a consistent, pathogen-free human skin substitute. J Trauma. 2009; 66(3):866-873.

Strattice

1. Dikmans RE, El Morabit F, Ottenhof MJ, et al. Single-stage breast reconstruction using Strattice^™: a retrospective study. J Plast Reconstr Aesthet Surg. 2016; 69(2):227-233.
2. Glasberg SB, Light D. AlloDerm and Strattice in breast reconstruction: a comparison and techniques for optimizing outcomes. Plast Reconstr Surg. 2012; 129(6):1223-1233.
3. Huntington CR, Cox TC, Blair LJ, et al. Biologic mesh in ventral hernia repair: outcomes, recurrence, and charge analysis. Surgery. 2016; 60(6):1517-1527.
4. Itani KM, Rosen M, Vargo D, et al.; RICH Study Group. Prospective study of single-stage repair of contaminated hernias using a biologic porcine tissue matrix: the RICH Study. Surgery. 2012; 152(3):498-505.
5. Kalstrup J, Balslev Willert C, Brinch-Møller Weitemeyer M, et al. Immediate direct-to-implant breast reconstruction with acellular dermal matrix: Evaluation of complications and safety. Breast. 2021; 60:192-198.
6. Lohmander F, Lagergren J, Roy PG, et al. Implant based breast reconstruction with acellular dermal matrix: safety data from an open-label, multicenter, randomized, controlled trial in the setting of breast cancer treatment. Ann Surg. 2019; 269(5):836-841.
7. Maxwell, GP, Gabriel, A. Non-cross-linked porcine acellular dermal matrix in revision breast surgery: long-term outcomes and safety with neopectoral pockets. Aesthet Surg J. 2014; 34(4):551-559.
8. Paprottka FJ, Krezdorn N, Sorg H, et al. Evaluation of complication rates after breast surgery using acellular dermal matrix: median follow-up of three years. Plast Surg Int. 2017; 2017:1283735.
9. Patel, K, Albino FP, Nahabedian MY, Bhanot P. Critical analysis of Strattice performance in complex abdominal wall reconstruction: intermediate-risk patients and early complications. Int Surg. 2013; 98(4):379-384.
10. Patel KM, Nahabedian MY, Gatti M, Bhanot P. Indications and outcomes following complex abdominal reconstruction with component separation combined with porcine acellular dermal matrix reinforcement. Ann Plast Surg. 2012; 69(4):394-398.
11. Richmond B, Ubert A, Judhan R, et al. Component separation with porcine acellular dermal reinforcement is superior to traditional bridged mesh repairs in the open repair of significant midline ventral hernia defects. Am Surg. 2014; 80(8):725-731
12. Rosen MJ, Krpata DM, Ermlich B, Blatnik JA. A 5-year clinical experience with single-staged repairs of infected and contaminated abdominal wall defects utilizing biologic mesh. Ann Surg. 2013; 257(6):991-996.
13. Wilson RL, Kirwan CC, O'Donoghue JM, et al. BROWSE: A multicentre comparison of nine year outcomes in acellular dermal matrix based and complete submuscular implant-based immediate breast reconstruction-aesthetics, capsular contracture and patient reported outcomes. Eur J Surg Oncol. 2021 Nov 6:S0748-7983(21)00776-9.
14. Wilson RL, Kirwan CC, Johnson RK, et al. Breast reconstruction outcomes with and without Strattice: long-term outcomes of a multicenter study comparing Strattice immediate implant breast reconstruction with submuscular implant reconstruction. Plast Reconstr Surg. 2023; 152(1):11-19.

SurgiMend

1. Asaad M, Selber JC, Adelman DM, et al. Allograft vs xenograft bioprosthetic mesh in tissue expander breast reconstruction: a blinded prospective randomized controlled trial. Aesthet Surg J. 2021. 41(12):NP1931-NP1939.
2. Asaad M, Morris N, Selber JC, et al. No differences in surgical and patient-reported outcomes among AlloDerm, SurgiMend, and Dermacell for prepectoral implant-based breast reconstruction. Plast Reconstr Surg. 2023; 151(5):719e-729e.
3. Barmettler A, Heo M. A Prospective, randomized comparison of lower eyelid retraction repair with autologous auricular cartilage, bovine acellular dermal matrix (SurgiMend), and porcine acellular dermal matrix (Enduragen) spacer grafts. Ophthalmic Plast Reconstr Surg. 2018; 34(3):266-273.
4. Butterfield JL. 440 Consecutive immediate, implant-based, single-surgeon breast reconstructions in 281 patients: a comparison of early outcomes and costs between SurgiMend fetal bovine and AlloDerm human cadaveric acellular dermal matrices. Plast Reconstr Surg. 2013; 131(5):940-951.
5. Chu JJ, Nelson JA, Kokosis G, et al. A cohort analysis of early outcomes after AlloDerm, FlexHD, and SurgiMend use in two-stage prepectoral breast reconstruction. Aesthet Surg J. 2023; 43(12):1491-1498.
6. Clemens MW, Selber JC, Liu J, et al. Bovine versus porcine acellular dermal matrix for complex abdominal wall reconstruction. Plast Reconstr Surg. 2013; 131(1):71-79.
7. Eichler C, Vogt N, Brunnert K, et al. A Head-to-head Comparison between SurgiMend and Epiflex in 127 Breast Reconstructions. Plast Reconstr Surg Glob Open. 2015; 3(6):e439.
8. Endress R, Choi MS, Lee GK. Use of fetal bovine acellular dermal xenograft with tissue expansion for staged breast reconstruction. Ann Plast Surg. 2012; 68(4):338-341.
9. Lampridis S, Billè A. A paradigm shift for diaphragmatic and chest wall reconstruction using a bovine acellular dermal matrix: an analysis versus synthetic meshes. Gen Thorac Cardiovasc Surg. 2023; 71(2):121-128.
10. Mazari FAK, Wattoo GM, Kazzazi NH, et al. The comparison of Strattice and SurgiMend in acellular dermal matrix-assisted, implant-based immediate breast reconstruction. Plast Reconstr Surg. 2018; 141(2):283-293.
11. Scheflan M, Grinberg-Rashi H, Hod K. Bovine acellular dermal matrix in immediate breast reconstruction: a retrospective, observational study with SurgiMend. Plast Reconstr Surg. 2018; 141(1):1e-10e.

TheraSkin

1. Armstrong D, Galiano R, Orgill D, et al. Multi-centre prospective randomised controlled clinical trial to evaluate a bioactive split thickness skin allograft vs standard of care in the treatment of diabetic foot ulcers. Int Wound J. 2022; 19(4):932-944.
2. Barbul A, Gurtner GC, Gordon H, et al. Matched-cohort study comparing bioactive human split-thickness skin allograft plus standard of care to standard of care alone in the treatment of diabetic ulcers: A retrospective analysis across 470 institutions [published correction appears in Wound Repair Regen. 2020;28(3):431]. Wound Repair Regen. 2020; 28(1):81-89.
3. DiDomenico L, Emch KJ, Landsman AR, Landsman A. A prospective comparison of diabetic foot ulcers treated with either a cryopreserved skin allograft or a bioengineered skin substitute. Wounds. 2011; 23(7):184-189.
4. Gurtner GC, Garcia AD, Bakewell K, Alarcon JB. A retrospective matched-cohort study of 3994 lower extremity wounds of multiple etiologies across 644 institutions comparing a bioactive human skin allograft, TheraSkin, plus standard of care, to standard of care alone. Int Wound J. 2020; 17(1):55-64.
5. Landsman AS, Cook J, Cook E, et al. A retrospective clinical study of 188 consecutive patients to examine the effectiveness of a biologically active cryopreserved human skin allograft (TheraSkin^®) on the treatment of diabetic foot ulcers and venous leg ulcers. Foot Ankle Spec. 2011; 4(1):29-41.
6. Sanders L, Landsman AS, Landsman A, et al. A prospective, multicenter, randomized, controlled clinical trial comparing a bioengineered skin substitute to a human skin allograft. Ostomy Wound Manage. 2014; 60(9):26-38.
7. Towler MA, Rush EW, Richardson MK, Williams CL. randomized, prospective, blinded-enrollment, head-to-head towler venous leg ulcer healing trial comparing living, bioengineered skin graft substitute (Apligraf) with living, cryopreserved, human skin allograft (TheraSkin). Clin Podiatr Med Surg. 2018; 35(3):357-365.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Agency for Healthcare Research and Quality (AHRQ). Technology Assessment: Skin substitutes for treating chronic wounds. February 2020. Available at: https://www.cms.gov/Medicare/Coverage/DeterminationProcess/downloads/id109TA.pdf. Accessed on March 19, 2025.
2. American Academy of Ophthalmology. What is Punctate Keratitis? May 13, 2024. Available at: https://www.aao.org/eye-health/ask-ophthalmologist-q/what-is-punctate-keratitis. Accessed on March 19, 2025.
3. American Academy of Orthopaedic Surgeons. Management of Rotator Cuff Injuries Evidence Based Clinical Practice Guideline. 2019. Available at: https://www.aaos.org/globalassets/quality-and-practice-resources/rotator-cuff/rotator-cuff-cpg-final-12-20-19.pdf. Accessed on March 19, 2025.
4. American Diabetes Association. Standards of Medical Care in Diabetes-2025. 2025; 48(Supplement 1):S1-363.
5. American Society of Plastic Surgeons. Evidence-Based Clinical Practice Guideline: Breast Reconstruction with Expanders and Implants. 2013 Available at: https://www.plasticsurgery.org/documents/Health-Policy/Guidelines/guideline-2013-breast-recon-expanders-implants.pdf. Accessed on March 19, 2025.
6. Centers for Medicare and Medicaid Services. Available at: https://www.cms.gov/medicare-coverage-database/search.aspx. Accessed on  March 19, 2025.
   • National Coverage Determination for Blood-Derived Products for Chronic Non-Healing Wounds. NCD #270.3. Effective April 13, 2021.
   • National Coverage Determination for Porcine Skin and Gradient Pressure Dressings. NCD #270.5. Effective date not posted.
   • National Coverage Determination for Services provided for the Diagnosis and Treatment of Diabetic Sensory Neuropathy with Loss of Protective Sensation (Diabetic Peripheral Neuropathy). NCD #70.2.1. Effective July 1, 2002.
   • National Coverage Determination for Treatment of Decubitus Ulcers. NCD #270.4. Effective date not posted.
   • National Coverage Determination for Collagen Meniscus Implant. NCD #150.12. Effective March 25 , 2010.
   • Local Coverage Determination for Application of Bioengineered Skin Substitutes to Lower Extremity Chronic Non-Healing Wounds. LCD # L35041. Effective on 10/01/2023.
7. Santema TB, Poyck PP, Ubbink DT. Skin grafting and tissue replacement for treating foot ulcers in people with diabetes. Cochrane Database Syst Rev. 2016;(2):CD011255.
8. Tao JP, Aakalu VK, Wladis EJ, et al. Bioengineered acellular dermal matrix spacer grafts for lower eyelid retraction repair: a report by the American Academy of Ophthalmology. Ophthalmology. 2020; 127(5):689-695.
9. Thomson SE, Ng NYB, Riehle MO, et al. Bioengineered nerve conduits and wraps for peripheral nerve repair of the upper limb. Cochrane Database Syst Rev. 2017(3):CD012574.
10. U.S. Food and Drug Administration Humanitarian Device Exemption (HDE). EPICEL (Cultured epidermal autografts). Rockville, MD: FDA. October 25, 2007. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfhde/hde.cfm?id=H990002. Accessed on March 19, 2025.
11. U.S. Food and Drug Administration PMA Premarket Notification Database. Integra Dermal Regeneration Template. P900033. Rockville, MD: FDA. January 11, 2016. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P900033S042. Accessed on  March 19, 2025.
12. U.S. Food and Drug Administration 510(k) Premarket Notification Database. Oasis Wound Matrix. K061711. Rockville, MD: FDA. July 19, 2006. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K061711. Accessed in March 19, 2025.
13. U.S. Food and Drug Administration 510(k) Premarket Notification Database. Phasix Mesh. Rockville, MD: FDA. September 29, 2016. Available at: K143380.pdf (fda.gov). Accessed on  March 19, 2025.
14. U.S. Food and Drug Administration 510(k) Premarket Notification Database. Phasix Mesh ST. Rockville, MD: FDA. April 25, 2018. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K173143. Accessed on March 19, 2025.
15. U.S. Food and Drug Administration 510(k) Premarket Notification Database. ReCell Autologous Harvesting Device. NO. BP170122. Rockville, MD: FDA. June 9, 2021. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=BP170122. Accessed on March 19, 2025.
16. U.S. Food and Drug Administration 510(k) Premarket Notification Database. SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction. K162965. Rockville, MD: FDA. February 16, 2017. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K162965.Accessed on March 19, 2025.
17. Westby MJ, Dumville JC, Soares MO, et al. Dressings and topical agents for treating pressure ulcers Cochrane Database Syst Rev. 2017;(6):CD011947.
18. Ye L, Cao Y, Yang W, Wu F, Lin J, Li L, Li C. Graft interposition for preventing Frey's syndrome in patients undergoing parotidectomy. Cochrane Database Syst Rev. 2019 Oct 3;10(10):CD012323.

1. National Library of Medicine (NIH). Burns. Last updated October 10, 2024. Available at: https://medlineplus.gov/burns.html. Accessed on March 19 2025.
2. National Library of Medicine (NIH). Diabetic Foot. Last updated March 15, 2024. Available at: https://medlineplus.gov/diabeticfoot.html. Accessed on  March 19, 2025.

Bilaminate Skin Substitute
Conjunctiva
Conjunctival resection
Corneal injuries
Corneal epithelial defect
Cornea
Culture-Derived Human Skin Equivalent
Human Skin Equivalent
Wound Healing
Xenograft

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