Product	Description	FDA Indication	Limitations
Acellular Dermal Matrix
AlloDerm®	Freeze dried cadaver skin with preserved basement membrane	*___	Uncertain vascularization rates, no cells present in scaffold, safety concerns of allogenic disease transfer
AlloMax™	Non-crosslinked human dermis	*___	No cells present in scaffold, safety concerns of allogenic disease transfer
FlexHD®	Hydrated acellular human skin	*___	No cells present in scaffold, safety concerns of allogenic disease transfer
DermaMatrix™	Allograft derived from human cadaveric skin	*___	No cells present in scaffold, safety concerns of allogenic disease transfer
GraftJacket®	Pre-meshed acellular human dermis	*___	No cells present in scaffold, safety concerns of allogenic disease transfer
Amniotic Membrane
EpiFix®	Dehydrated amniotic membrane in sheets	*___	Safety concerns of allogenic disease transfer, unclear effect on angiogenesis
Amniofix®	Injectable micronized dehydrated amniotic membrane	*___	Safety concerns of allogenic disease transfer, unclear effect on angiogenesis
Collagen Scaffold
OASIS® Wound Matrix	Xenogeneic collagen scaffold derived from porcine small intestine	Partial and full thickness wounds; diabetic, pressure, and venous stasis ulcers; surgical wounds, traumatic wounds	Requires multiple applications
Living Cell Therapy
Apligraf®	Bilayered construct w/ human neonatal fibroblasts cultured in bovine type 1 collagen matrix and human neonatal keratinocytes forming the superficial layer of the graft- mimics normal structure of skin	Non-infected, partial and full thickness skin ulcers due to venous insufficiency; nonresponsive full thickness neuropathic diabetic ulcers	Shelf life of 5 days, risk of disease transfer from allogeneic cells, cannot be used for definitive wound closure in full thickness wounds, requires co-grafting with autologous epithelium
Dermagraft®	Cryopreserved polyglactin mesh seeded w/ human neonatal foreskin fibroblasts	Diabetic foot ulcers	Requires multiple applications, safety concerns with allogeneic cells
Epicel	Cultured epithelial autograft	Deep dermal or full thickness burns	Requires long culture times, short shelf life, variable take rate
OrCel®	Bilayered construct w/ human neonatal foreskin fibroblasts and keratinocytes seeded in bovine type 1 collagen sponge	Donor site wounds in burn victims; dystrophic epidermolysis bullosa reconstructive surgery	Allogeneic cell source risk of disease transfer
Biosynthetic
Biobrane®	Temporary wound dressing consisting of nylon imbedded silicon film	Partial thickness burn wounds, donor sites, dressing over meshed autografts	Non-degradable/synthetic and must be removed after 7–14 days
Integra	Bovine type 1 collagen and shark chondroitin-6-sulphate glycosaminoglycan dermal component and silicone epidermal layer	Post-excisional treatment of deep partial thickness or full thickness due to thermal injury	Requires about 10–14 days for appropriate vascularization and requires second procedure for complete wound closure
TransCyte®	Temporary wound dressing consisting of human dermal fibroblasts grown on nylon mesh containing porcine collagen	Temporary covering over burns until autografting procedure or healed	Non-degradable/synthetic and must be removed after 7–14 days

^*Considered “banked human tissue” and does not require FDA approval