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Cellular and/or Tissue Based Products - Evidence Guide for Non-DFU/Non-VLU Wounds

Cellular and/or Tissue Based Products - Evidence Guide for Non-DFU/Non-VLU Wounds

Cellular and/or Tissue Based Products - Evidence Guide for Non-DFU/Non-VLU Wounds

ABSTRACT

Reimbursement for cellular and/or tissue-based products (CTPs) - also referred to as Cellular, Acellular, and Matrix-Like Products (CAMPs) or skin substitutes - in the U.S. outpatient setting is generally limited by payers (e.g., Medicare) to diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) that have not responded to at least four weeks (30 days) of documented standard of care, with evidence of adherence to the prescribed treatment plan.[1][2][3][4][5][6]  As a result , coverage is not guaranteed if a clinician chooses to apply CTPs/CAMPs for ulcers of other etiologies (non-DFU/non-VLU). This guide classifies evidence by product and wound etiology, providing a clear reference for drafting evidence-based justification prior to CTP/CAMP application on non-DFU/non-VLU ulcers. 

The goal of this tool is to equip providers with concise, product-specific, evidence-based language - derived from clinical and regulatory literature - to support the medical necessity of a selected CTP/CAMP when 30 days of standard wound care has not achieved adequate healing in non-DFU/non-VLU wound etiologies.

For an overview on cellular and tissue products (CTPs) from the clinical, coverage and reimbursement perspective, refer to topic " Cellular and/or Tissue Based Products ". For guidance on selection of CPT see " How to Select Cellular and/or Tissue Products ". For decision support on different CTP brands, see interactive feature matrices   “Human Skin Allografts” ,  “Allogeneic Matrix” ,  “Composite Matrix”  and “ Acellular Matrix ”. For Centers for Medicare & Medicaid Services (CMS) payment updates effective January 1, 2026, see blog post " Skin Substitutes - What’s New in 2026? Navigating CMS Payment Changes ".

INTRODUCTION

Overview

Reimbursement for  cellular and/or tissue-based products (CTPs) - also known as Cellular, Acellular, and Matrix-Like Products (CAMPs)  or skin substitutes - in the U.S. outpatient setting is typically limited by payers (e.g. Medicare) to diabetic foot ulcers (DFUs) and venous ulcers (VLUs) that have failed to respond to  documented standard of care treatment for a  minimum of four weeks (defined as 30 days) with documented compliance to prescribed treatment.[1][2][3][4][5][6][7] However, evidence supports their adjunctive use in other types of chronic, non-healing wounds. These include wounds such as pressure injuries, non-healing surgical sites, and soft tissue radiation wounds.

This practical guide summarizes the evidence for using specific CTPs/ CAMPs/ skin substitutes as adjunctive modalities for management of chronic wounds other than DFUs or VLUs (i.e., non-DFU/non-VLU). It also includes guidance on the regulatory framework and necessary clinical documentation.

For an overview on cellular and tissue products (CTPs) from the clinical, coverage and reimbursement perspective, refer to topic " Cellular and/or Tissue Based Products" . For guidance on selection of CPT see " How to Select Cellular and/or Tissue Products ". For decision support on different CTP brands, see interactive feature matrices   “Human Skin Allografts” ,  “Allogeneic Matrix” ,  “Composite Matrix”  and “ Acellular Matrix ”. For Centers for Medicare & Medicaid Services (CMS) payment updates effective January 1, 2026, see blog post " Skin Substitutes - What’s New in 2026? Navigating CMS Payment Changes".

Background

Definitions

  • Standard of care : the standard of care is a legal term that represents the benchmark used to determine whether professional obligations to patients have been met. It is defined as “ a measure of the duty that practitioners owe patients to make medical decisions in accordance with what any other prudent practitioner would do when treating the same condition in a similar patient .” [8] See topic " Standard of Care: Foundations for Wound Management".
    • Under the Centers for Medicare & Medicaid Services (CMS) , the standard of care represents the accepted, evidence-based comprehensive wound care plan that includes all evidence-based elements required for healing - such as vascular assessment, infection control, offloading, nutritional optimization, and management of comorbidities - required to establish medical necessity and justify reimbursement for wound care services. [1][2][3][4][5][6]

Relevance

CTP/CAMP Coverage for Non-Diabetic Foot Ulcers (DFUs) or Venous Leg Ulcers (VLUs)
  • Current payers’ Local Coverage Determinations (LCDs) typically limit the use of CTPs/CAMPs to DFUs and VLUs.[1][2][3][4][5][6]  Consequently, coverage is not guaranteed if a clinician chooses to apply CTPs/CAMPs for ulcers of other etiologies (non-DFU/non-VLU). Therefore, when considering the application and potential reimbursement of a CTP/CAMP for ulcers other than DFUs or VLUs, the following steps are recommended:
    • Review the Medicare Administrative Contractor's (MAC)  LCD: consult your MAC's specific LCD for CTP/CAMP. The covered indications, including non-DFU/VLU wounds, may be explicitly outlined.
    • Contact your MAC: If your MAC does not have an active CTP/CAMP LCD, direct contact is advised to confirm coverage policies for other wound etiologies.
    • Consult clinical evidence : review the available clinical evidence and recommendations for the chosen product's use in the specific non-DFU/VLU wound type (e.g., pressure ulcers/injuries, arterial ulcers, surgical wounds). Products supported by a high level of evidence are preferable, especially if an appeal is anticipated. See section CTPs/ CAMPs/ Skin Substitutes Evidence Guide for Non-DFU/Non-VLU Wounds ' below.
  • Important considerations for clinicians: i n addition to the evidence outlined in this topic, it is essential that documentation meets the CMS' requirements for application of CTPs/CAMPs, as detailed in  section ' Documentation requirements' in topic "Cellular and/or Tissue Based Products ".
    • Evidence-based product selection : select a CTP/CAMP with strong evidence supporting its efficacy for the specific wound type. This is crucial for justifying medical necessity and supporting potential appeals of denied claims. 
    • Detailed documentation : comprehensive documentation proving the medical necessity of the CTP/CAMP is essential. This includes documentation of the intent to utilize the advanced therapy prior to the first application, documentation of prior failed therapies, detailed wound assessments, and the rationale for choosing the specific product . 
    • Advance Beneficiary Notice (ABN) : if pre-determination or prior knowledge suggests the CTP/CAMP is not covered by the MAC for the patient's wound type, inform the patient. Offer the option of signing an ABN. This notifies the patient that they will be financially responsible for the product and service if the claim is denied.

FDA Regulation of  CTPs/ CAMPs/ Skin Substitutes

  • In the United States (U.S.), CTPs/ CAMPs/ skin substitutes are regulated by the U.S. Food & Drug Administration (FDA) under different pathways based on their origin, composition, and mechanism of action.[1][2][3]  Regulatory classification depends on whether the product meets criteria for tissue regulation, device clearance/approval, or biologic licensure. [1][2][3]
  • FDA regulatory pathways include [1][2][3]:
    • Section 361 Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) : regulated under Public Health Service Act Section 361 and 21 CFR Part 1271. These products are not subject to premarket approval or clearance but must meet criteria such as minimal manipulation and homologous use.
    • Medical Devices : regulated under the Federal Food, Drug, and Cosmetic Act and may require:
      • 510(k) clearance (substantial equivalence), or
      • Premarket Approval (PMA) (for higher-risk devices)
    • Biological Products (Section 351) : licensed under Public Health Service Act Section 351 and require a Biologics License Application (BLA)
CMS Considerations
  • CMS has implemented policies that align reimbursement with FDA regulatory pathways, particularly distinguishing between :
    • Products regulated as 351 biologics (typically reimbursed based on ASP methodologies), and
    • Products treated as supplies or incident-to items (e.g., many 361 HCT/Ps, 510(k) and PMA)
  • For details, refer to " Skin Substitutes - What’s New in 2026? Navigating CMS Payment Changes".
Documentation Requirement
  • To support compliance and reimbursement, clinical documentation should clearly reflect that the CTP/CAMP is used in accordance with its FDA regulatory classification and labeled indications, including intended use and application method.[9][10][11]

Table 1 below  summarizes the FDA regulatory pathway and labeled/intended-use language for selected CTPs/CAMPs/skin substitutes grouped by product type . Regulatory status varies by product and may include regulation as a 361 HCT/P,  510(k),  or PMA-approved device/combination product. Product use should be consistent with the applicable FDA regulatory status, labeling, and manufacturer instructions for use. The FDA-labeled intended-use language can also be found in FDA notifications available in FDA databases. [12] 

Table 1. Selected  CTPs/CAMPs/skin substitutes grouped by product type, with corresponding U.S. regulatory pathway and  FDA / labeled intended-use language,  as stated in FDA notifications available in the FDA Databases [12]

Product (HCPCS) U.S. Regulatory pathway  FDA / labeled intended-use language 
Acellular matrix

Kerecis  marigen shield (A2019) 510(k) Intended for the management of wounds, including partial- and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, tunneled/undermined wounds, diabetic ulcers, trauma wounds, surgical wounds, and draining wounds.
Allogeneic matrix

EpiFix (Q4186)  361 HCT/P  Intended for use as a barrier in acute and chronic wounds; provides a protective environment to support the healing process and development of granulation tissue.
Grafix PRIME (Q4133)  361 HCT/P  Limited to homologous use as a wound cover and may be used for acute and chronic wounds.
Composite matrix

Apligraf  (Q4101) PMA -approved Class III device Indicated for use with standard therapeutic compression for non-infected partial- and full-thickness venous leg ulcers of greater than 1 month duration that have not adequately responded to conventional ulcer therapy. Also indicated with standard diabetic foot ulcer care for full-thickness neuropathic diabetic foot ulcers of greater than 3 weeks duration that have not adequately responded to conventional therapy and extend through the dermis without tendon, muscle, capsule, or bone exposure.
Human skin allograft

TheraSkin (Q4121) human skin allograft 361 HCT/P  Human skin allograft that may be used in applications for repair of human skin.
Synthetic matrix

Mirragen (A2002) 510(k) Intended for the management of wounds, including partial- and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, tunneled/undermined wounds, diabetic ulcers, trauma wounds, surgical wounds, and draining wounds.

CTPs/CAMPs for Non-DFU/Non-VLU Wounds: Interpreting Study Types and Evidence Levels 

  • Evidence-based practice in wound care, particularly for the application of CTPs/CAMPs in wounds other than DFUs/VLUs, relies heavily on the quality of supporting clinical research. The established levels of evidence provide a hierarchical framework to classify study types, indicating their reliability and strength in guiding clinical decisions. 
  • Understanding the hierarchy - from systematic reviews and randomized controlled trials (RCTs) at the highest levels, down to observational studies and expert opinion - is crucial. See topic " An Introduction to Evidence-based Practice in Wound Care". For CTPs/CAMPs in non-DFU/non-VLU wounds, high-level evidence like well-designed RCTs is ideal for establishing efficacy and safety. However, the limited number of such studies specific to these wound etiologies means clinicians often must rely on lower-level evidence.
  • Understanding levels of evidence is essential for standardizing the assessment of data supporting CTPs/CAMPs use:
    • A robust evidence base (Level I or II) provides strong justification for clinical protocols and reimbursement.
    • Conversely, relying solely on lower-level evidence (e.g., case series or expert consensus) highlights an area where the strength of the recommendation is weaker, necessitating careful clinical judgment and consideration of individual patient factors.
    • This structured approach ensures that the application of CTPs/CAMPs is guided by the best available science, mitigating inconsistencies and promoting optimal patient outcomes. 

CTPs/ CAMPs/ SKIN SUBSTITUTES EVIDENCE GUIDE FOR NON-DFU/NON-VLU WOUNDS


Current payers’ Local Coverage Determinations (LCDs) typically limit the use of CTPs/CAMPs to DFUs and VLUs in the outpatient setting.[1][2][3][4][5][6] Consequently, coverage is not guaranteed if a clinician chooses to apply CTPs/CAMPs for ulcers of other etiologies (non-DFU/non-VLU). This  guide classifies evidence by product and wound etiology, providing a clear reference for drafting evidence-based justification prior to CTP/CAMP application on non-DFU/non-VLU ulcers.

  • The goal of this tool is to equip providers with concise, product-specific, evidence-based language - derived from clinical and regulatory literature - to support the medical necessity of a selected CTP/CAMP when 30 days of standard wound care has not achieved adequate healing in non-DFU/non-VLU wound etiologies.
  • Key messages to be included in clinical documentation:
    • Failure of standard care : The wound has failed to demonstrate progress toward healing (e.g., < 50% area reduction) despite a minimum of 30 days of appropriate Standard of Care (SOC), which includes but is not limited to: sharp debridement, infection control, offloading, and/or compression, as applicable.
    • Evidence-based support : The selected CTP/ CAMP/ skin substitute is supported by clinical evidence (retrospective studies, case series, or RCTs, as detailed in the following tables) for the management of this specific wound type.
    • Regulatory compliance: The CTP/ CAMP/ skin substitute  is being used consistent with its FDA-approved classification (HCT/P, 510(k) cleared, or PMA-approved indication, with justification for off-label use as necessary).
  • In addition to the evidence summarized below, it is essential that clinical documentation meets the CMS' requirements for application of CTPs/ CAMPs/ skin substitutes, as detailed in  section ' Documentation requirements' in topic "Cellular and/or Tissue Based Products ".
  • Note: 
    • Studies summarized in Tables 2–5 are specific to the products listed. These tables will be updated as new evidence becomes available.

Chronic Wounds in General (non-DFU/non-VLU)

Table 2. Product-Specific Evidence and Documentation Framework for CTPs/ CAMPs/ Skin substitutes for Chronic Wounds in General (non-DFU/non-VLU)

Product Regulatory Framing Highest level of evidence Sample Documentation
EpiFix HCT/P (21 CFR 1271); protective wound covering, supports healing cascade Retrospective case series
  • The wound has failed to progress despite appropriate standard care for 30 days. Published retrospective study and case series support consideration of dehydrated amnion/chorion membrane in refractory nonhealing wounds. [EpiFix] is planned for application as a human cellular/tissue-based product under 21 CFR Part 1271, to function as a protective wound covering supporting the healing cascade and granulation tissue formation. 
    • In a 2013 case series (n=4), Sheikh et al. reported that dHACM (EpiFix) supported healing progression in chronic wounds of mixed etiologies (3 postoperative wound dehiscence, 1 traumatic wound) that had failed prior therapies, suggesting a role in refractory nonhealing wounds. [13]  
    • In 2016, Mrugala et al. reported in a case series of 5 patients with 6 chronic, nonhealing lower-extremity wounds that had failed standard care that treatment with dehydrated human amnion/chorion membrane (dHACM) allograft was associated with substantial wound area reduction and progression to complete healing in most cases, with a median time to closure of approximately 64 days and no reported adverse events. These findings support consideration of dHACM allografts used as wound coverings in the management of complex, nonhealing wounds.  [14]
    • In 2018, Garoufalis et al. published a retrospective comparative study (n=117 patients) evaluating dehydrated human amnion/chorion membrane (dHACM, EpiFix) allografts in the treatment of lower-extremity wounds of multiple etiologies, including surgical wounds, pressure ulcer/injuries, arterial ulcers and traumatic wounds. Complete healing occurred in 91.1% of treated patients, with a mean ± standard deviation number of weekly applications per healed wound of 5.1 ± 4.2.  [15]
Grafix HCT/P; homologous use as wound covering Retrospective cohort study
  • The wound demonstrates inadequate healing despite standard care for 30 days. Published retrospective studies and case series support consideration of placental membranes in chronic and stalled wounds. Grafix is planned for use consistent with its homologous function as a wound covering under 21 CFR Part 1271.
    • In a 2015 case series (n=3), Gibbons et al. reported that chronic wounds of multiple etiologies (including a stage 4 pressure injury, a diabetic foot ulcer, and a traumatic wound) that had failed prior advanced therapies progressed to healing following standard of care and adjunct application of cryopreserved placental membrane (Grafix) used as a wound covering. These findings support consideration of placental membrane allografts in complex, nonhealing wounds.  [16]  
    • In 2017, Johnson et al. published a retrospective comparative outcomes analysis of 79 patients with 101 wounds of multiple etiologies, including chronic, surgical, diabetic, and pressure ulcers/injuries, treated with either viable cryopreserved placental membrane (vCPM; Grafix, n=40) or dehydrated amnion/chorion membrane (dHACM, n=39). The study reported significantly higher wound closure rates following standard of care combined with application of vCPM (63.0%) compared to standard of care and dHACM (18.2%), despite treatment of larger wounds.  [17]  
    • In a 2019 multicenter retrospective case series (n=78 patients, 98 wounds), Ananian et al. reported that chronic wounds of multiple etiologies (including diabetic, venous, surgical, and other wound types) achieved an overall closure rate of approximately 59% following standard of care and adjunct use of lyopreserved placental membrane containing viable cells (GrafixPL PRIME), with no treatment-related adverse events. Outcomes were comparable to those previously reported for cryopreserved placental membranes. These findings support consideration of placental membrane allografts used as wound coverings, consistent with their homologous function, in the management of complex, nonhealing wounds.  [18]  
TheraSkin HCT/P; repair/replacement of human skin Retrospective cohort study
  • The wound has not demonstrated adequate healing progression despite appropriate care for 30 days. Published retrospective cohort studies support consideration of cryopreserved human skin allografts in chronic wounds. [TheraSkin] is planned for application for the repair of human skin under 21 CFR Part 1271. 
    • In 2019, Gurtner et al. published a large retrospective propensity-matched cohort study (n = 3,994 lower-extremity wounds) evaluating a cryopreserved human skin allograft (TheraSkin) in conjunction with standard of care (SOC) compared to SOC alone across wounds of multiple etiologies including diabetic, lymphedema, pressure ulcer/injury, radiation, surgical wound, trauma, venous and arterial ulcers. The study demonstrated that TheraSkin + SOC was associated with significantly higher healing rates (68.3% vs 60.3%), greater percent area reduction (78.7% vs 68.9%), fewer amputations, lower recidivism, and higher treatment completion compared to SOC alone.  [19]    
Kerecis 510(k); broad wound indications Prospective, single-arm (uncontrolled) case series
  • The wound has failed to progress despite appropriate standard care for 30 days. Published clinical studies support consideration of fish skin grafts in complex, nonhealing wounds. [Kerecis] is planned for use consistent with its FDA-cleared indications for management of partial- and full-thickness wounds. 
    • In 2016, Yang  et al. published a prospective postmarket compassionate clinical evaluation (n = 18 patients) of an acellular fish skin graft (Kerecis) in conjunction with standard of care (SOC) for hard-to-heal lower-extremity chronic ulcers that had failed prior therapies. Patients received SOC and weekly applications of the graft, resulting in a significant reduction in wound surface area (~40%) and wound depth (~48%) after 5 weeks, with progression toward closure observed in treated wounds and no product-related adverse events.  [20]   
    • In 2021, Tan et al published a case report describing a renal transplant recipient with calciphylaxis-associated chronic skin ulceration, a severe form of ischemic and necrotic soft tissue injury, that had failed prior standard therapies. The patient was treated with intralesional sodium thiosulfate, intravenous sodium thiosulphate and fish skin graft in conjunction with standard of care (SOC), resulting in progressive wound healing and resolution of cutaneous lesions.  [21]  
    • In 2023, Tickner et al. published an expert consensus statement based on a structured nominal focus group process involving 8 wound care specialists, synthesizing available literature and clinical experience to generate 43 consensus recommendations for the use of intact fish skin grafts (Kerecis) in conjunction with standard of care (SOC) for acute and chronic lower extremity wounds of multiple etiologies, including diabetic foot ulcers, venous leg ulcers, traumatic wounds, and atypical wounds. The recommendations emphasize adherence to SOC - including debridement, offloading, compression therapy, and vascular assessment - prior to initiation of fish skin graft therapy, and support its use as an adjunctive treatment in chronic wounds that fail to demonstrate adequate healing after approximately 4 weeks of SOC.  [22]  
    • In 2025, Dinter et al. published a retrospective observational real-world study (n = 34 patients, 50 chronic wounds) evaluating an acellular fish skin graft (Kerecis) in conjunction with standard of care (SOC) for chronic, nonhealing wounds of multiple etiologies including lymphedema, pressure ulcers/injuries and burns. Over a 12-week follow-up period, treatment with fish skin graft + SOC was associated with significant reductions in wound surface area (mean reduction ~60.7%), improvement in pain in approximately two-thirds of patients, and complete wound healing in 36.4% of wounds.  [23]  
    • In 2025, Ivana et al. published a systematic review (n = 158 patients across 6 studies, mostly retrospective) evaluating acellular fish skin grafts in the treatment of chronic wounds of multiple etiologies, including diabetic ulcers, burns, surgical and other complex wounds. Across included studies, fish skin grafts used in conjunction with standard of care (SOC) were associated with accelerated wound healing, with some wounds achieving complete closure as early as 30 days and improved healing rates compared to conventional dressings.  [24]
Apligraf PMA; FDA-approved for DFU/VLU only Case series
  • The wound has failed to progress despite standard therapy for 30 days. Published case series describe use of bioengineered skin substitutes in complex wounds. Apligraf is FDA-approved for treatment of diabetic foot ulcers and venous leg ulcers; use in this case is being considered based on clinical judgment due to wound complexity and lack of response to standard care. 
    • In 2006, Shealy et al. published a retrospective case series (n = 16 patients, 18 wounds) evaluating a bioengineered bilayered living cell construct (Apligraf) in conjunction with standard of care (SOC) for complicated surgical and nonsurgical wounds of multiple etiologies, including off-label use on chronic and acute wounds that had failed prior therapies, such as nonhealing surgical, radiation and traumatic wounds. Application of Apligraf + SOC resulted in high rates of healing, with 94% of patients (15/16) achieving complete healing and 89% of wounds (16/18) closing, with healing times ranging from 21 to 550 days.  [25]
    • In 2014, Penny et al. published a case study (n = 1 patient with 3 wounds) describing the management of necrobiosis lipoidica–associated chronic lower-extremity ulceration refractory to prior standard therapies over a 6–12 month period. The wounds were treated with a bioengineered bilayered living cell construct (Apligraf) in conjunction with standard of care (SOC). Following initiation of Apligraf + SOC, wounds 1 and 2 achieved closure within 45 days and wound 3 within 68 days, demonstrating substantially improved healing compared to prior treatment courses.  [26]

Non-healing Surgical Wounds 

Table 3. Product-Specific Evidence and Documentation Framework for CTPs/ CAMPs/ Skin substitutes for Non-healing Surgical Wounds

Product Regulatory Framing Evidence Type Sample Documentation
EpiFix HCT/P; wound covering Case series
  • The surgical wound demonstrates delayed healing despite appropriate care for 30 days. Published retrospective study and case series support consideration of dehydrated amnion/chorion membrane in complex surgical wounds - including Mohs micrographic surgery defects - support consideration of placental allografts. [EpiFix] is planned for application as a protective wound covering under 21 CFR Part 1271. 
    • In 2018, Garoufalis et al. published a retrospective comparative study (n=117 patients) evaluating dehydrated human amnion/chorion membrane (dHACM, EpiFix) allografts in the treatment of lower-extremity wounds of multiple etiologies, including surgical wounds, pressure ulcer/injuries, arterial ulcers and traumatic wounds. Complete healing occurred in 91.1% of treated patients, with a mean ± standard deviation number of weekly applications per healed wound of 5.1 ± 4.2.  [15]
    • In a 2018 case series, Lyons et al. reported that dehydrated amnion/chorion membrane (EpiFix) supported granulation and healing in 5 elderly patients with full-thickness scalp defects after Mohs surgery, with no reported complications, suggesting a role in complex wounds where surgical repair is not feasible.  [27]    
    • In a 2022 retrospective case–control study (n = 286 patients), Toman et al. reported that placental allograft (dHACM) demonstrated comparable or lower complication rates than autologous tissue repairs in Mohs surgical defects, supporting its use as a wound covering in complex surgical wounds.  [28]
    • In 2023, Moradi et al. published a retrospective comparative study (n = 80 patients) evaluating dehydrated human amnion/chorion membrane (dHACM) allograft in conjunction with standard of care (SOC) for postoperative wounds following Mohs micrographic surgery. The study demonstrated that wounds treated with dHACM + SOC achieved significantly faster healing compared to SOC alone (mean 5.2 vs 6.5 weeks; P = .01). These findings support consideration of dHACM allografts used as wound coverings, in addition to SOC, in complex surgical wounds, including Mohs defects, particularly when standard closure is not feasible.  [29]
Grafix HCT/P; homologous use Retrospective cohort study
  • The surgical wound remains nonhealing despite standard care for 30 days. Published literature supports use of placental membrane products in complex surgical wounds. Grafix is planned for use consistent with its homologous function as a wound covering under 21 CFR Part 1271. 
    • In 2017, Johnson et al. published a retrospective comparative outcomes analysis of 79 patients with 101 wounds of multiple etiologies, including chronic, surgical, diabetic, and pressure wounds, treated with either viable cryopreserved placental membrane (vCPM; Grafix, n=40) or dehydrated amnion/chorion membrane (dHACM, n=39). The study reported significantly higher wound closure rates following standard of care combined with application of vCPM (63.0%) compared to standard of care and dHACM (18.2%), despite treatment of larger wounds.  [17]  
    • In a 2019 multicenter retrospective case series (n=78 patients, 98 wounds), Ananian et al. reported that chronic wounds of multiple etiologies (including diabetic, venous, surgical, and other wound types) achieved an overall closure rate of approximately 59% following standard of care and adjunct use of lyopreserved placental membrane containing viable cells (GrafixPL PRIME), with no treatment-related adverse events. Outcomes were comparable to those previously reported for cryopreserved placental membranes. These findings support consideration of placental membrane allografts used as wound coverings, consistent with their homologous function, in the management of complex, nonhealing wounds.  [18]    
TheraSkin HCT/P; skin repair Retrospective cohort
  • The surgical wound demonstrates impaired healing despite appropriate management for 30 days. Published literature supports use of human skin allografts in nonhealing surgical wounds. [TheraSkin] is planned for application for the repair of human skin under 21 CFR Part 1271.
    • In 2019, Gurtner et al. published a large retrospective propensity-matched cohort study (n = 3,994 lower-extremity wounds) evaluating a cryopreserved human skin allograft (TheraSkin) in conjunction with standard of care (SOC) compared to SOC alone across wounds of multiple etiologies including diabetic, lymphedema, pressure ulcer/injury, radiation, surgical wound, trauma, venous and arterial ulcers. The study demonstrated that TheraSkin + SOC was associated with significantly higher healing rates (68.3% vs 60.3%), greater percent area reduction (78.7% vs 68.9%), fewer amputations, lower recidivism, and higher treatment completion compared to SOC alone.  [19]  
Kerecis 510(k); includes surgical wounds Retrospective case series
  • The surgical wound has not progressed as expected despite standard care for 30 days. Published case series and reports support consideration of fish skin grafts in non-healing postoperative wounds. [Kerecis] is planned for use consistent with its FDA-cleared indications including surgical wounds.   
    • In 2025, O’Quinn et al. published a multicenter retrospective case series (n=41 patients) evaluating intact fish skin graft (IFSG; Kerecis) in conjunction with standard of care (SOC) for the management of post–Mohs micrographic surgery wounds of varying sizes and anatomical locations. The study included patients with complex surgical defects following skin cancer excision. Forty of 41 wounds (97.6%) achieved complete wound closure in a median of 5 weeks, and the median number of visits was 5. For closed wounds, the median number of applications was 2.  [30]
    • In 2025, Ivana et al. published a systematic review (n = 158 patients across 6 studies, mostly retrospective) evaluating acellular fish skin grafts in the treatment of chronic wounds of multiple etiologies, including diabetic ulcers, burns, surgical and other complex wounds. Across included studies, fish skin grafts used in conjunction with standard of care (SOC) were associated with accelerated wound healing, with some wounds achieving complete closure as early as 30 days and improved healing rates compared to conventional dressings.  [24]  
Apligraf PMA; DFU/VLU only Retrospective case series
  • The surgical wound remains nonhealing despite standard therapy for 30 days. Published case series describe use in complex surgical wounds. Apligraf is FDA-approved for DFU/VLU; use in this case is being considered based on clinical judgment following failure of standard care. 
    • In 2006, Shealy et al. published a retrospective case series (n = 16 patients, 18 wounds) evaluating a bioengineered bilayered living cell construct (Apligraf®) in conjunction with standard of care (SOC) for complicated surgical and nonsurgical wounds of multiple etiologies, including off-label use on chronic and acute wounds that had failed prior therapies, such as nonhealing surgical, radiation and traumatic wounds. Application of Apligraf + SOC resulted in high rates of healing, with 94% of patients (15/16) achieving complete healing and 89% of wounds (16/18) closing, with healing times ranging from 21 to 550 days.  [25]    
    • In 2004, Allie et al. published a retrospective cohort study comparing standard of care (SOC) alone with the use of a bioengineered bilayered living cell construct (Apligraf®) in conjunction with SOC for the management of postoperative sternal (n=15) and lower-extremity surgical wound complications (n=45) following coronary artery bypass grafting (CABG). The study demonstrated that treatment with Apligraf + SOC was associated with almost twice as fast wound healing and successful closure of complex surgical wounds, including those with delayed healing after conventional therapy.  [31]    

Soft Tissue Radionecrosis

Table 4. Product-Specific Evidence and Documentation Framework for CTPs/ CAMPs/ Skin substitutes for Soft Tissue Radionecrosis

Product Regulatory Framing Evidence Type Sample Documentation
EpiFix HCT/P Case report
  • The wound reflects radiation-related tissue injury with impaired healing despite standard care for 30 days. Published literature supports use of amniotic membrane products in nonhealing wounds of irradiated skin. [EpiFix] is planned for application as a protective wound covering under 21 CFR Part 1271.   
    • In a 2019 case report with brief review, Henderson et al. described a patient with a chronic, nonhealing wound consistent with radiation-associated soft tissue injury (radionecrosis) that had failed prior standard therapies. The patient was treated with dehydrated human amnion/chorion membrane (dHACM) in conjunction with hyperbaric oxygen therapy (HBOT) and standard of care (SOC). The wound demonstrated progressive granulation and eventual healing following combined therapy, highlighting the impaired healing environment of radiation-damaged tissue and the potential benefit of multimodal treatment approaches. These findings support consideration of dHACM allografts used as wound coverings, in conjunction with SOC and adjunctive therapies such as HBOT, in the management of complex, nonhealing radiation-associated wounds.  [32]
Grafix HCT/P Case report
  • The wound demonstrates radiation-induced tissue damage with poor healing progression despite standard of care for 30 days. Published case report support consideration of placental membrane products in selected cases. Grafix is planned for use consistent with homologous function as a wound covering under 21 CFR Part 1271.
    • In 2019, Regulski et al. reported in a case study that a chronic radiation-associated wound that had failed prior therapies progressed to healing following treatment with standard of care and use of a viable placental membrane (GrafixPL PRIME®), suggesting a role for placental membrane allografts used as wound coverings in complex, nonhealing wounds.  [33]    
TheraSkin HCT/P Retrospective cohort
  • The radiation wound remains nonhealing despite appropriate care for 30 days. Published literature supports adjunctive use of human skin allograft in nonhealing wounds of irradiated skin. [TheraSkin] is planned for application for repair of human skin under 21 CFR Part 1271.
    • In 2019, Gurtner et al. published a large retrospective propensity-matched cohort study (n = 3,994 lower-extremity wounds) evaluating a cryopreserved human skin allograft (TheraSkin) in conjunction with standard of care (SOC) compared to SOC alone across wounds of multiple etiologies including diabetic, lymphedema, pressure ulcer/injury, radiation, surgical wound, trauma, venous and arterial ulcers. The study demonstrated that TheraSkin + SOC was associated with significantly higher healing rates (68.3% vs 60.3%), greater percent area reduction (78.7% vs 68.9%), fewer amputations, lower recidivism, and higher treatment completion compared to SOC alone.  [19]    
Kerecis 510(k) Case reports
  • The wound demonstrates radiation-associated injury and lack of healing despite standard therapy for 30 days. Published case reports support consideration of fish skin grafts in complex radiation wounds. Kerecis is planned for use consistent with its FDA-cleared wound indications.   
    • In 2023, Di Mitri et al. published a case report (n = 1 patient) describing the use of an acellular fish skin graft (Kerecis) in conjunction with standard of care (SOC) for a pediatric abdominal wall wound dehiscence, a complex postoperative surgical wound. The graft was fully resorbed over time and was associated with improved tissue repair and progression toward wound healing.  [34]     
    • In 2024, Veitinger et al. published a case report (n = 1 patient) describing the management of a chronic, nonhealing head and neck surgical wound with exposed skull bone following multiple resections for squamous cell carcinoma. The wound, which had failed prior standard therapies, was treated with an acellular fish skin graft (Kerecis) in conjunction with standard of care (SOC). Rapid granulation tissue formation was observed within one week, enabling subsequent definitive closure with a full-thickness skin graft, with complete wound closure achieved within 2 weeks.  [35]
    • In 2025, Zhivov et al. published a case report (n = 1 patient) describing the management of a chronic, nonhealing wound consistent with radiation-associated soft tissue injury (soft tissue radionecrosis) that had failed prior standard therapies. The patient was treated with an intact acellular fish skin graft (Kerecis) in conjunction with standard of care (SOC). The wound demonstrated progressive granulation and advancement toward healing, highlighting the challenges of radiation-damaged tissue and the potential role of advanced biologic dressings in supporting repair.  [36]
Apligraf PMA; DFU/VLU only Case reports
  • The wound is associated with prior radiation and has failed to progress despite standard care for 30 days. Published case reports describe use of bioengineered skin substitutes in similar complex wounds. Apligraf is FDA-approved for DFU/VLU; use in this case is being considered based on clinical judgment due to failure of standard therapy.  
    • In 2006, Shealy et al. published a retrospective case series (n = 16 patients, 18 wounds) evaluating a bioengineered bilayered living cell construct (Apligraf) in conjunction with standard of care (SOC) for complicated surgical and nonsurgical wounds of multiple etiologies, including off-label use on chronic and acute wounds that had failed prior therapies, such as nonhealing surgical, radiation and traumatic wounds. Application of Apligraf + SOC resulted in high rates of healing, with 94% of patients (15/16) achieving complete healing and 89% of wounds (16/18) closing, with healing times ranging from 21 to 550 days.  [25]    
    • In 2011, Vlassova et al. published a case report (n = 1 patient) describing the management of a chronic radiation-associated chest wall ulcer with exposed rib following lumpectomy, radiation therapy, mastectomy, and reconstruction. The wound had failed prolonged standard of care (SOC) over approximately one year, including advanced dressings, hyperbaric oxygen therapy, and prior biologic matrices. Treatment with a bioengineered bilayered living cell construct (Apligraf®) in conjunction with SOC resulted in the development of healthy granulation tissue over exposed bone after initial application, and complete wound closure after 3 applications, with sustained healing thereafter.  [37]    

Pressure Ulcers/Injuries

Table 5. Product-Specific Evidence and Documentation Framework for CTPs/ CAMPs/ Skin substitutes for Pressure Ulcers/Injuries

Product Regulatory Framing Evidence Type Sample Documentation
EpiFix HCT/P Prospective case series
  • The pressure injury has failed to progress despite appropriate standard care for 30 days. Published literature supports consideration of dehydrated human amnion/chorion membrane in nonhealing wounds. [EpiFix] is planned for application as a protective wound covering under 21 CFR Part 1271.   
    • In 2019, Berhane et al. published a prospective case series (n = 10 patients) evaluating dehydrated human amnion/chorion membrane (dHACM; EpiFix) in conjunction with standard of care (SOC) for the treatment of Stage 2 and 3 pressure ulcers/injuries. Patients received weekly applications of dHACM + SOC, and 70% of wounds demonstrated reduction in size after the first application, with 40% achieving greater than 50% area reduction within two w eeks. These findings support consideration of dHACM allografts used as wound coverings, in addition to SOC, in the management of pressure ulcers/injuries that have not responded adequately to standard care.  [38]
Grafix HCT/P Randomized controlled trial
  • The pressure ulcer/injury remains nonhealing despite standard care for 30 days. Published literature supports use of placental tissue allograft in chronic wounds, including pressure ulcers/injuries. [Grafix] is planned for use consistent with homologous function as a wound covering under 21 CFR Part 1271. 
    • In 2017, Johnson et al. published a retrospective comparative outcomes analysis of 79 patients with 101 wounds of multiple etiologies, including chronic, surgical, diabetic, and pressure ulcers/injuries, treated with either viable cryopreserved placental membrane (vCPM; Grafix, n=40) or dehydrated amnion/chorion membrane (dHACM, n=39). The study reported significantly higher wound closure rates following standard of care combined with application of vCPM (63.0%) compared to standard of care and dHACM (18.2%), despite treatment of larger wounds.  [17]    
    • In 2017 Dehghani M et al. published a small randomized controlled trial (n=24 patients, low certainty evidence due to small size and no assessors’ blinding) reporting that complete pressure ulcer healing occurred only in the interventional group (pressure ulcers treated with amniotic membranes) (p<0.001). Partial healing was significantly higher in the amnion group (p<0.03) compared with the control group (pressure ulcers treated with local Dilantin powder).  [39]
TheraSkin HCT/P Retrospective cohort
  • The pressure ulcer/injury demonstrates delayed healing despite standard of care for 30 days. Published literature supports use of human skin allografts in nonhealing pressure ulcers/injuries. [TheraSkin] is planned for application for the repair of human skin under 21 CFR Part 1271. 
    • In 2019, Gurtner et al. published a large retrospective propensity-matched cohort study (n = 3,994 lower-extremity wounds) evaluating a cryopreserved human skin allograft (TheraSkin) in conjunction with standard of care (SOC) compared to SOC alone across wounds of multiple etiologies including diabetic, lymphedema, pressure ulcer/injury, radiation, surgical wound, trauma, venous and arterial ulcers. The study demonstrated that TheraSkin + SOC was associated with significantly higher healing rates (68.3% vs 60.3%), greater percent area reduction (78.7% vs 68.9%), fewer amputations, lower recidivism, and higher treatment completion compared to SOC alone.  [19]    
Kerecis 510(k); includes pressure ulcers Prospective case series
  • The pressure injury has not improved despite standard care for 30 days. Published literature supports consideration of fish skin grafts in complex wounds. [Kerecis] is planned for use consistent with its FDA-cleared indications including pressure ulcers/injuries. 
    • In 2016, Yang et al. published a prospective postmarket compassionate clinical evaluation (n = 18 patients) assessing an acellular fish skin graft (Kerecis) in conjunction with standard of care (SOC) for chronic, nonhealing lower-extremity ulcers of multiple etiologies including pressure ulcers/injuries that had failed prior therapies. Patients received weekly applications of fish skin graft + SOC, resulting in significant reductions in wound area over the treatment period and progression toward closure in treated wounds.  [20]  
    • In 2025, Dinter et al. published a retrospective observational real-world study (n = 34 patients, 50 chronic wounds) evaluating an acellular fish skin graft (Kerecis) in conjunction with standard of care (SOC) for chronic, nonhealing wounds of multiple etiologies including lymphedema, pressure ulcers/injuries and burns. Over a 12-week follow-up period, treatment with fish skin graft + SOC was associated with significant reductions in wound surface area (mean reduction ~60.7%), improvement in pain in approximately two-thirds of patients, and complete wound healing in 36.4% of wounds.  [23]
Apligraf PMA; DFU/VLU only Retrospective comparative effectiveness study
  • The pressure-related wound remains nonhealing despite standard therapy. Published studies describe use in selected cases. Apligraf is FDA-approved for DFU/VLU; use in this case is being considered based on clinical judgment due to failure of standard care. 
    • In 2024, Sabolinski et al. published a retrospective comparative effectiveness study using real-world data evaluating a bilayered living cellular construct (BLCC; Apligraf) compared with a fetal bovine collagen-based dressing (FBCD) in conjunction with standard of care (SOC) for the treatment of pressure injuries. The study demonstrated that BLCC + SOC was associated with significantly improved healing outcomes, including a 66% greater probability of healing and an approximately 2-month reduction in time to healing compared to FBCD + SOC.  [40]   
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REFERENCES

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  17. Eric L. Johnson MD, James T. Marshall MHS, CWS, PA-C, Georgina M. Michael MSN, FNP-BC et al. A comparative outcomes analysis evaluating clinical effectiveness in two different human placental membrane products for wound management . 2016;.
  18. Ananian CE, Davis RD, Johnson EL, Regulski MJ, Reyzelman AM, Saunders MC, Danilkovitch A et al. Wound Closure Outcomes Suggest Clinical Equivalency Between Lyopreserved and Cryopreserved Placental Membranes Containing Viable Cells. Advances in wound care. 2019;volume 8(11):546-554.
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Topic 3255 Version 1.0

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