Table 2.

Categories of Substitute Products or Cellular and/or Tissue-Based Products for Burn Wound Care, with Examples of Currently Used Products

Product category	Description and components	Indications and usea	Products (manufacturer)	FDA regulatory pathwayb	Comments
Synthetic	Wound coverings made up of nonbiological materials. Products may reduce inflammation, increase the rate of epithelialization, and provide a scaffold for tissue regeneration.217–220	For temporary coverage of burn wounds.217,220,221	BioDegradable Temporizing Matrix/NovoSorb BTM® (PolyNovo Biomaterials Pty Ltd.)221	510(k) FRO221	For partial-thickness burns.221 Contraindicated for clinically infected wounds.220
			Suprathel (PolyMedics Innovations, Inc.)219	510(k) FRO217	For partial-thickness burns.217 Contraindicated for clinically infected wounds.217
Synthetic and allogeneic nonviable cells ± tissues	Wound coverings made from a synthetic scaffolding embedded with cells or tissue (human or xenogeneic). Products may increase the healing and reepithelialization rate.222,223	For temporary coverage of burn wounds or autograft donor sites, depending on the product.223,224	Biobrane™ (Smith & Nephew)163	510(k) FRO163	For partial-thickness burns.223
			TransCyte™ (Organogenesis, Inc.)c,222	PMA224	For partial- and full-thickness burns.224 Contraindicated for patients sensitive to materials with a bovine origin and for clinically infected wounds.222
Autologous derived	Skin substitutes made from autologous cells. Supplements or reduces the need for extensive autografting.225,226	For the treatment of adult and pediatric burn wounds. These products may be used alone or with autografts.225,226	Epicel® (Vericel Corporation)226	HDE226	For full-thickness burns.226 Contraindicated for patients with a history of anaphylaxis to vancomycin, amikacin, and amphotericin; patients sensitive to materials with a bovine or murine origin; and clinically infected wounds.226
			ReCell® (Avita Medical, Inc.)225	PMA225	For partial- or full-thickness burns.225 Contraindicated for clinically infected wounds or wounds with necrotic tissue and patients with a hypersensitivity to trypsin or compound sodium lactate solution (Hartmann's Solution).225
Placental tissue allografts	Allografts made from dehydrated human amnion and/or chorion membrane. Products may modulate inflammation and support granulation tissue development.227,228	For the treatment of burn wounds.227,228	AmnioBurn®/EpiFix®/AmnioFix® (MiMedx Tissue Services, LLC)163,229	HCT/P 361d,163,229	For partial- and full-thickness burns.227 Contraindicated for wounds with an active or latent infection and patients with disorders that would create an unacceptable risk of postoperative complications.228
Xenografts	Acellular wound coverings of animal origin, such as bovine or porcine. Products may mitigate the inflammatory response, provide a scaffold for tissue regeneration, and facilitate remodeling.163,230–234	For the coverage of burn wounds. Some products may be used in conjunction with standard of care.230,233,234	Cytal® Burn Matrix/sheet MatriStem® (ACell, Inc.)230	510(k) KGN163	For partial-thickness burns.230
			Oasis® Burn Matrix (Smith & Nephew)234	510(k) KGN163	For partial-thickness burns.234 Contraindicated for full-thickness burns and patients with sensitivity to porcine material.234
			Integra® DRT/ Omnigraft® DRM (Integra Life Sciences Corporation)233	PMA163	For partial- and full-thickness burns.233 Contraindicated for patients with hypersensitivity to bovine collagen or chondroitin materials and clinically infected wounds.233
Other human tissue allografts	Acellular human cadaveric dermis allograft.235	For the replacement of tissue in burn wound repair.235,236	Alloderm™ RTM (LifeCell Corporation, an Abbvie company)237	HCT/P 361d,235	For partial- and full-thickness burns.d,235,236 Contraindicated for patients with sensitivity to polysorbate 20 or any antibiotic listed on the package label.235
Bioengineered constructs combining cells and/or tissues	Products using bioactive human keratinocytes on a xenogeneic matrix embedded with human fibroblasts. Products may contain stem or progenitor cells.161,196,238,239	For the treatment of burn wounds.196	Apligraf® (Organogenesis, Inc.)238	PMA238	For partial- and full-thickness skin ulcers due to venous insufficiency and full-thickness neuropathic diabetic foot ulcers.e,238 Contraindicated for clinically infected wounds; patients allergic to bovine collagen; and patients with a hypersensitivity to the Apligraf agarose shipping medium.238
			StrataGraft® (Stratatech Corporation, a Mallinckrodt company)240	BLA240	For partial-thickness burns.196 Contraindicated for patients with allergies to murine collagen or products of bovine or porcine origin.196

^a Products may also be indicated for other wound types.

^b Pathways through which currently marketed products for burn wounds have been cleared.

^c Formerly Dermagraft-TC.¹⁶³ TransCyte is FDA cleared, but not on the U.S. market.

^d 361 Indicates HCT/P products regulated under the Center for Biologics Evaluation and Research under 21 Code of Federal Regulations 1271.3(d)(1) and Section 361 of the Public Health Service Act.¹⁶⁴ Previously, the FDA exercised enforcement discretion for certain regenerative medicine products so that they did not require premarket review and approval.¹⁶⁶ As of May 31, 2021, all HCT/P manufacturers were required to file an Investigational New Drug application or a BLA to legally market their products.¹⁶⁵

^e Apligraf is used off-label to treat burns.

BLA, biologics license application; DRM, dermal regeneration matrix; DRT, dermal regeneration template; FDA, U.S. Food and Drug Administration; FRO/KGN, product code for medical devices; HCT/P, human cells, tissues, and cellular and tissue-based product; HDE, Humanitarian Device Exemption; PMA, premarket approval.