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Snyder D, Sullivan N, Margolis D, et al. Skin Substitutes for Treating Chronic Wounds [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2020 Feb 2.

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Skin Substitutes for Treating Chronic Wounds [Internet].

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Appendix DCommercially Available Skin Substitute Products

Table D-1Acellular/Dermal replacement from donated human dermis (14 products in this category)

ProductManufacturerManufacturer’s Product DescriptionManufacturer Claims
AlloPatch®Musculoskeletal Transplant Foundation (dba MTF Biologics), Edison, NJ, USAAlloPatch is human allograft skin minimally processed to remove epidermal and dermal cells. The process preserves the extracellular matrix of the dermis. AlloPatch is aseptically processed and is not terminally sterilized. AlloPatch is processed to remove cells while maintaining the integrity of the matrix to address the issues of the specific and nonspecific inflammatory responses. It is used to replace damaged or inadequate integumental tissue or to repair, reinforce, or supplement soft-tissue defects.

“Allopatch is minimally processed, which better preserves and maintains the graft’s natural biomechanical and biochemical properties. Unlike other ECMs [extracellular membranes] that need to be hydrated for 60 minutes or more before being used, delaying procedure completion and prolonging OR time, Allopatch requires no refrigeration or hydration and is ready to use off the shelf almost immediately.”

3-year shelf life at ambient temperature.

AlloPatch® PliableMusculoskeletal Transplant Foundation (dba MTF Biologics)AlloPatch Pliable is an aseptically processed human reticular dermal tissue for use as a chronic or acute wound covering.“AlloPatch Pliable tissue is processed from deep cut tissue from which the epidermal layer has been physically removed. The process utilized preserves the extracellular matrix of the dermis. The resulting allograft serves as a framework to support cellular repopulation and vascularization at the surgical site. Open tissue architecture optimal for cell infiltration and host tissue remodeling.” 3-year shelf life at ambient temperature.
Alloskin™ AC Acellular Dermal MatrixAlloSource, Centennial, CO, USAAlloSkin AC is a meshed dermis-only human skin graft that has been decellularized while preserving the natural biologic components and structure of the dermal matrix.

“The graft provides a favorable microenvironment for bio-ingrowth to begin revascularization and cellular repopulation. Single application often sufficient to potentially help stimulate the wound healing process. Ready-to-use off the shelf. Pliable and stretchable for contouring to wound topography and maintenance of wound bed contact. Robust enough to suture or staple. Meshed (1:1) encouraging fluid drainage from wound.”

Ready-to-use, shelf-stable graft with room temperature storage, eliminating the need for costly cryo freezers.

AlloSkin™ RTAlloSourceAlloSkin RT meshed human dermal graft is a sterile skin graft with broad clinical applications for acute and chronic wound therapy.

“Skin allografts mechanically protect the wound and provide biologic factors native to human skin, which may help stimulate the wound healing process. AlloSource’s process uses electron beam irradiation to yield a ready-to-use, shelf-stable graft with room temperature storage, eliminating the need for costly cryo freezers. Pliable and stretchable, AlloSkin RT allows graft contouring to wound topography, yet is robust enough to suture or staple graft without tearing. In addition, 1:1 meshing encourages exudate drainage from wound, allowing the graft to be secure to the surface and avoid ‘floating’.”

Ready-to-use, shelf-stable graft with room temperature storage, eliminating the need for costly cryo freezers

Coll-e-derm™Parametrics Medical, Leander, TX, USAColl-e-derm is a human derived dermal allograft that is decellularized using a proprietary method to preserve the biological properties for wound healing.

“The natural collagen and elastin matrix is ideal for neovascularization and cellular proliferation. Coll-e-Derm maintains the strength of human skin and provides a natural scaffold for cellular and capillary remodeling of a damaged site, which can expedite the healing process. Benefits: Terminally Sterile at 10-6 with low dose precision gamma irradiation, lowering risk of infection.

Supplied lyophilized at room temperature for easy storage and handling.”

DermACELL® Human Acellular Dermal Matrix. DermACELL AWM is intended for chronic wounds.LifeNet Health®, Virginia Beach, VA, USADermACELL is a technologically advanced human acellular dermal matrix. DermACELL is decellularized using Matracell®, a proprietary and patented technology that removes ≥97% of donor DNA without compromising the graft’s desired biomechanical or biochemical properties and allows for rapid cellular infiltration and revascularization.“DermACELL is ready to use out of the package and stored at room temperature, eliminating the need for refrigeration and rehydrating processes. As a final step, all DermACELL grafts are terminally sterilized-rendering the graft sterile to medical device-grade standards with a SAL of 10-6.” “Facilitates cell proliferation and migration, critical for wound management.”
Dermapure®Tissue Regenix Group, San Antonio, TX, USADermaPure is a decellurized human dermis product thatworks by taking donated human dermis and removing the nucleated cells and cellular debris, using the patented dCELL® Technology process to create a natural biological scaffold that is up to 99% DNA-free.“The decellularized dermal allograft aids the natural healing process by providing an environment that supports cell migration to facilitate the body’s repair, or replacement, of damaged or inadequate integumental tissue. DermaPure maintains the structure and biochemical characteristics of native dermis, fully integrating into the wound bed after application. It provides a scaffold into which the recipient’s cells can grow, becoming vascularized and supporting the generation of a new epithelial layer, ultimately regenerating native skin.” Ambient temperature storage.
DermaSpan™ Acellular Dermal MatrixZimmer Biomet. (manufactured by Biomet Orthopedics, Warsaw, IN, USA)DermaSpan Acellular Dermal Matrix is derived from allograft human skin and carefully processed to offer biocompatibility as well as biomechanical strength. DermaSpan ACD can be used in various practices, including orthopedics, plastic surgery, and general surgery, to repair or replace damaged or inadequate integumental tissue (wound coverage).

DermaSpan Acellular Dermal Matrix is very carefully processed to offer biocompatibility as well as biomechanical strength in tendon coverage or reinforcement and wound coverage procedures. DermaSpan Acellular Dermal Matrix has the added advantage of being supplied sterile…unlike many other dermal allograft products.”

Does not need refrigeration.

FlowerDerm™Flower Orthopedics, Horsham, PA, USAFlowerDerm is a meshed dermis-only decellularized human skin graft that preserves the natural biologic components and structure of the dermal matrix. The graft provides a favorable environment for revascularization and cellular repopulation.

“A single application of this product is often sufficient to stimulate the wound healing process. The pliable, flexible material adheres to wound topography and maintains contact with the wound bed. It’s also durable enough to suture or staple and has a mesh construction to encourage fluid drainage. FlowerDerm is ready for use right off the shelf.”

Stored at room temperature, 2-year shelf life.

GammaGraft™Promethean LifeSciences, Inc., Pittsburgh, PA, USAGammaGraft is an irradiated human skin allograft storable at room temperature. Used as a temporary skin graft on burns and chronic wounds.

GammaGraft has unrivalled ease of use and safety and provides one of the easiest biological grafts for patient compliance. Promethean’s proprietary technology sterilizes and preserves the tissues. This technique leads to safer grafts as well as ones that are easier to handle and use. Many doctors and nurses are skeptical that GammaGraft can be used without any other wound coverings after the GammaGraft has dried on the wound. This is possible because GammaGraft has a natural keratin layer that acts as a vapor barrier for the wound. This allows for moist wound healing and a moist wound bed, even though the GammaGraft is dry.”

Stored at ambient temperature

GraftJacket™ RTMWright Medical Group N.V., Memphis, TN, USAGraftJacket Matrix is used to provide supplemental support, protection, and reinforcement of tendon and ligamentous tissue; to be used as a periosteal patch or covering; or for protection and support of bone and tendons in foot and ankle and hand surgery. It is a human dermal collagen matrix that is readily incorporated into the body. The matrix undergoes a patented process that renders the material essentially acellular and is freeze-dried with a proprietary process that prevents the formation of ice crystals to preserve the intact matrix, including vascular channels.

“The Graftjacket Matrix provides a scaffold for host cell repopulation, revascularization and, ultimately, conversion to host tissue. Coupled with excellent tensile and suture retention strength, the biological characteristics of the Graftjacket Matrix make it an excellent scaffold to reinforce primary soft-tissue repairs throughout the body while eliminating morbidity associated with harvesting autograft.”

Stored at room temperature, 2-year shelf life.

hMatrix® ADMBacterin International, Inc., Belgrade, MT, USAhMatrix ADM is an allograft derived from donated human skin. The dermis is processed using a proprietary method to remove the cells to maximize graft incorporation. The natural collagen and elastin matrix is ideal for neovascularization and cellular proliferation and has the potential to expedite the healing process. hMatrix ADM is provided as a sterile product with a device-level (SAL) of 10-6.“The successful treatment of deep wounds often requires the use of a dermoconductive graft material to facilitate formation of granulation tissue and aid in wound closure. One such graft material used for this purpose is allograft-derived acellular dermis. ADM are used as a primary grafting material that can replace damaged or inadequate dermal tissue while helping to reduce the size of the wound and providing protection to the site of injury.
  • Superior suture retention strength.
  • Flexible matrix for precise placement.
  • Lower inflammatory response vs. competitors.
  • Distributed as a frozen product.
  • Sterility assurance level (SAL) 10-6.
  • 5 year shelf life.
  • Frozen storage.”
InteguPly®Aziyo Biologics, Silver Spring, MD, USAInteguPly is human ACD processed to maintain the biologic and structural integrity of the tissue’s extracellular matrix components, while delivering a SAL of 10-6. Promoted for treating chronic wounds.“Supports the repair or replacement of integumental tissue, as well as closure of chronic diabetic foot ulcers, venous leg ulcers and pressure wounds.”
  • “Intact extracellular matrix that promotes tissue remodeling.
  • Superior safety profile-over 20,000 applications with no adverse reactions reported.”
Matrix HD® AllograftRTI Surgical, Alachua, FL, USAMatrix HD allograft is an acellular human dermis allograft sterilized using the Tutoplast™ Tissue Sterilization process. This proprietary process retains the 3-dimensional intertwined multidirectional fibers and mechanical properties of the native dermis tissue.

“The Matrix HD graft provides a natural scaffold to support the body’s regenerative process.”

“Sterile–Terminally sterilized to a SAL of 106. Validated viral inactivation.

Biocompatible: Preserved vascular channels. Preserved key components of the native matrix.”

“Convenient: Room temperature storage. Five year shelf life.

Simple, single-step rehydration.”

ADM=acellular dermal matrix; OR=operating room; SAL=sterility assurance level

Table D-2Acellular/Dermal replacement from human placental membrane (28 products in this category)

ProductManufacturerManufacturer’s Product DescriptionManufacturer Claims
AlloWrap®AlloSource, Centennial, CO, USAAlloWrap is a human amniotic membrane containing bioactive proteins that support wound healing.

“Strong, pliable tissue conforms to wound topography. Amniotic tissue is naturally rich in growth factors to support the healing process, and provides an immune-privileged barrier to support the patient’s body in preventing inflammation and scar tissue generation. Available in a moist configuration (AlloWrap DS) or dry (AlloWrap Dry) designed for ease of handling in wound care placements.

Room temperature storage, with two-year shelf life, no need for expensive cryo freezer storage.”

AltiPlast®Aziyo Biologics, Silver Spring, MD, USAAltiPlast is a cryopreserved placental matrix derived from human amniotic and chorionic membranes.AltiPlast provides a universal approach to treating complex, chronic wounds. Whether an irregular, tunneling or undermining wound, AltiPlast finds its way, reaching deep into the wound to treat hidden fissures. The matrix components intimately contact the wound bed to support closure. AltiPlast is adaptable and ready to integrate into your treatment approach.” Frozen.
AmnioBand® Allograft Placental MatrixMTF Biologics, Edison, NJ, USAAmnioBand is a minimally processed human allograft that retains the structural properties of the extracellular matrix. The resulting dehydrated allograft serves as a wound covering.

“Maintains inherent growth factors and matrix proteins essential to wound healing and host tissue remodeling. Aseptic processing preserves tissue’s natural structure.

Ready, right out of the package. Can be used in the hydrated or dehydrated state. Shelf life of three years at ambient temperature. Conforms to anatomy and maintains surface contact.”

Amnioexcel®Integra LifeSciences Corp. acquired Derma Sciences, Plainsboro, NJ, USAAmnioexcel is dehydrated human amnion-derived tissue allograft with intact extracellular matrix intended for use as a wound covering to aid in closing chronic wounds.

“The membrane forms a protective covering over the wound while providing the key components found in human amnion including an intact ECM, cytokines and other growth factors. It easily integrates into the wound and helps provide the optimal environment to repair, reconstruct and replace wound tissue.”

Room-temperature stable for 2 years

AmnioFill® Human Placental Tissue AllograftMiMedx Group, Inc., Marietta, GA, USAAmnioFill is a nonviable cellular tissue matrix allograft that contains multiple extracellular matrix proteins, growth factors, cytokines, and other specialty proteins present in placental tissue to help enhance healing.

“Human collagen matrix. Contains growth factors that modulate inflammation, reduce scarring, and enhance healing. Versatile tissue form provides a scaffold for ingrowth in acute and chronic wounds. Terminally sterilized for enhanced patient safety. PURION® processed to provide an effective allograft with excellent handling characteristics.

5 year shelf life stored at ambient conditions.”

AmnioFix® Amnion/Chorion Membrane AllograftMiMedx GroupAmnioFix is a bioactive tissue matrix allograft composed of dehydrated human amnion/chorion membrane (dHACM) that preserves and contains multiple extracellular matrix proteins, growth factors, cytokines, and other specialty proteins. AmnioFix is intended to reduce scar tissue formation, modulate inflammation, enhance surgical wound healing, and act as a barrier membrane.

“Acts as a barrier membrane. Reduces scar tissue formation. Modulates inflammation. Enhances healing. Terminally sterilized for enhanced patient safety. PURION® processed to provide an effective allograft with excellent handling characteristics.

5 year shelf life stored at ambient conditions.”

Amniomatrix® Human Amniotic Suspension AllograftIntegra LifeSciences acquired Derma SciencesAmniomatrix is a cryopreserved suspension allograft derived from the amniotic membrane and components of the amniotic fluid. It is cryopreserved using the patented CryoPrime™ processing method that preserves the structural properties of the collagen, cytokines, growth factors, ECM, and viable cellular materials. Amniomatrix is intended to help supplement the recipient’s tissue and aid in the closing of chronic wounds.

“The liquid based suspension is especially suited to help repair wounds where membrane products might not be as effective (i.e. tunneling or deep wounds).”

Should be stored at -60°C or below.

Artacent® WoundTides Medical, Lafayette, LA, USAWound-specific, dual-layer amniotic tissue graft designed for enhanced efficacy and ease-of-use. Intended for chronic wounds.

Artacent Wound is the only wound-specific amniotic patch that can be applied with either side facing the wound. Amniotic tissues are safe, natural biologic barriers, with native membranes supplying a wide array of growth factors. The unique design of Artacent Wound allows for easy manipulation and repositioning, making it a flexible, dependable option for a variety of wound covering applications.”

Dehydrated, storage at room temperature, shelf life greater than 2 years.

BioDFactor® Viable Tissue MatrixIntegra LifeSciences, originally BioD, LLCBioDFactor Viable Tissue Matrix is a flowable tissue allograft derived from morselized amniotic tissue and components of the amniotic fluid.

BioDFactor® Viable Tissue Matrix is a cryopreserved allograft derived from the human placental tissues. It has been developed for use as a wound covering in the treatment of localized tissue defects or areas of inflammation. Placental tissues are a rich source of collagen, elastin, fibronectin, and growth factors to support tissue repair and regeneration. Additionally, amniotic tissue has anti-adhesive and anti-microbial properties important in the treatment of soft tissue injuries.”

Maintain the product at -65°C or colder until immediately prior to use, 2 year shelf life

Biodfence®Integra LifeSciences, originally BioD, LLCBioDFence® G3 and BioDDryFlex® are membrane allografts derived from the human placental tissues for use as a tissue barrier that covers and protects the underlying tissues. BioDFence G3 is a multilayer amnion and chorion allograft providing enhanced handling characteristics. BioDDryFlex is a single-layer amniotic allograft for applications in which bulk may not be optimal.

Website does not list any specific benefits for chronic wounds.

Ambient temperature storage, terminally sterilized with a 5-year shelf life.

Biovance® Amniotic Membrane AllograftAlliqua Biomedical, Langhorne, PA, USABiovance is a decellularized, dehydrated human amniotic membrane (DDHAM) with a preserved natural epithelial basement membrane and an intact ECM structure with its biochemical components. The epithelial basement membrane and ECM of this allograft provide a natural scaffold that allows cellular attachment or infiltration and growth factor storage. Biovance provides a protective cover and supports the body’s wound healing processes. Biovance is an allograft intended for use as a biological membrane covering that provides the ECM while supporting the repair of damaged tissue. It is intended for chronic wounds.“The easy-to-use human amniotic membrane allograft with 5-year off-theshelf convenience ease of application and wound visualization. The progenerative power of the amniotic membrane supports the body’s natural ability to restore tissue to a pre-wound state. The natural function of the amniotic membrane brings protection and support to the wound it covers. BIOVANCE contains natural substances found in amniotic membrane tissue that support the body’s ability to heal.”
Cellesta Amniotic MembraneVentris Medical, Newport Beach, CA, USACellesta Amniotic Membrane is a placental allograft product. The single-layered allografts are affixed to a poly mesh backing and can be sutured, glued, or laid over the desired tissue. Only the poly mesh is removed; either side of the graft may be applied to the target tissue. This natural human tissue scaffold with relevant, inherent characteristics can be used for therapeutic solutions.

“Cellesta is a natural human tissue scaffold that protects and cushions, just as it does in utero. Made up of growth factors, hyaluronic acid, cytokines, amino acids, and extracellular matrix proteins, it makes an attractive wound material.”

Store at ambient temperature.

Cygnus® Amnion Patch AllograftsVivex Biomedical, Atlanta, GA, USACygnus is applied as an anatomic barrier that helps provide mechanical protection while supporting healing with endogenous growth factors. The Cygnus proprietary process preserves the natural healing properties of amniotic tissue, maintaining inherent levels of key extracellular matrix molecules, growth factors, and cytokines.“Requires no up-front preparation, and hydrates rapidly in the surgical site
  • Stored at ambient temperature with a 5-year shelf-life.
  • Orientation stickers and notch in the upper left hand corner allow placement of the patch epithelial side up and stromal side down.
  • E-Beam sterilization provides sterility assurance level (SAL) of 10-6.”
Dermavest® and Plurivest® Human Placental Connective Tissue MatrixAedicell, Inc., Honeoye Falls, NY, USADermavest Human Placental Tissue Matrix (HPTM) is comprised of donated human placental tissue (placenta disc, amnion/chorion and umbilical cord) that has been particularized, processed to remove cells, cellular material and contamination, freeze-dried to remove moisture, pressed into a sheet then E-beam irradiated at a minimum 17.5 kGy with a validated sterilization process.”

“Dermavest provides a scaffold to replace damaged or inadequate integumental tissue.”

Store at room temperature. 3-year shelf life.

EpiCord®MiMedxEpiCord is a dehydrated, non-viable cellular umbilical cord allograft.… EpiCord is processed using the PURION® PLUS process, a unique approach that provides an easy to use allograft stored at ambient conditions.”

“EpiCord provides a protective environment for the healing process. Provides a connective tissue matrix to replace or supplement damaged or inadequate integumental tissue.

5 year shelf life stored at ambient conditions.”

Epifix®MiMedxEpifix is a dehydrated human amnion/chorion membrane (dHACM) allograft. EpiFix is a bioactive tissue matrix allograft composed of dHACM that preserves and contains multiple ECM proteins, growth factors, cytokines, and other specialty proteins. Promoted to treat diabetic foot ulcers and venous leg ulcers.
  • “Acts as a barrier membrane.
  • Reduces scar tissue formation.
  • Modulates inflammation.
  • Enhances healing.
  • Terminally sterilized for enhanced patient safety.
  • Purion processed to provide an effective allograft with excellent handling characteristics.
  • 5 year shelf life stored at ambient conditions.”
FlowerAmnioPatch™ and FlowerAmnioFlo™Flower Orthopedics, Horsham, PA, USAFlowerAmnioPatch is a dual-layer amniotic membrane allograft and FlowerAmnioFlo is a flowable amnion tissue allograft.
  • “FlowerAmnioPatch is a Ready-for-Surgery™, dual-layer amniotic membrane allograft with excellent handling characteristics.
  • Safe, natural covering that improves wound healing.
  • Reduces inflammation.
  • Adhesion barrier.
  • Reduces scarring at surgical site.
  • Decreases post-operative pain.”
  • Stored at room temperature.
Genesis Amniotic MembraneGenesis Biologics, Anaheim, CAGenesis Amniotic Membrane is derived from human placenta.Since amnion contains natural growth factors, cytokines, and hyaluronic acid, there are no steroidal side effects. Application of Genesis Amniotic Fluid scaffold helps in the composition of wound healing. Genesis Amniotic Membrane lowers inflammation and diminishes scar tissue.
Integra® BioFix® Amniotic Membrane AllograftIntegra LifeSciencesIntegra BioFix and Integra BioFix Plus (BioFix) are sterile, human tissue allografts derived from allogeneic dehydrated and decellularized amniotic membrane. BioFix is intended for use as a wound covering for surgical sites, voids, and tissue defects.

BioFix Amniotic Allografts are carefully processed using HydraTek® technology, a proprietary process designed to preserve the natural structure and biological properties of the tissue, to provide ideal graft handling, strength, and performance.”

“Features & Benefits:

  • Omnidirectional Placement–Membranes can be implanted on either side to provide an effective covering and gliding surface over the tissue.
  • Foundation for Regeneration–The Extracellular Matrix contains collagen and other fibrous proteins that provide a structural scaffold to support cellular migration. Naturally occurring growth factors, fibronectin, integrins, laminins, and hyaluronic acid play a key role in cell proliferation, differentiation, and adherence to the scaffold.”
Store at ambient temperature.

Integra BioFix Flow Placental Tissue Matrix AllograftIntegra LifeSciencesIntegra BioFix Flow is a sterile, human tissue allograft derived from decellularized particulate human placental connective tissue matrix. It is intended for use as a connective tissue matrix.“Features & Benefits:
  • Off-the-Shelf Storage–BioFix Flow can be stored at an ambient temperature for 5 years.
  • Reduces Inflammation, Scarring, and Pain–Amniotic tissues may reduce inflammation, fibrous tissue growth, and potential scar tissue formation.
  • Flexible Application–BioFix Flow is ready to implant and precisely targets defects using a range of needle gauges for ease of implantation.”
Interfyl™ Human Connective Tissue MatrixAlliqua Biomedical, Langhorne, PA, USAInterfyl is connective tissue matrix filler derived from the placenta of a healthy, full-term pregnancy. Available in flowable and particulate formulations.“Support tissue regeneration in complex surgical spaces.” “An adaptable filler of decellularized connective tissue matrix:
  • Able to completely fill irregular spaces or soft tissue voids resulting from trauma, surgery, or aging.
  • Allows for cell adherence and growth during tissue repair.
  • Consists of natural human structural and biochemical extracellular matrix components.
  • Adapts to local mechanical forces.
  • Provides structural support while maintaining elasticity.”
Store in its original packaging in a clean, dry environment at an ambient room temperature.
Neox® Wound AllograftsAmniox Medical, Inc., Miami, FL, USANeox Wound Matrix is human umbilical cord and amniotic membrane preserved to maintain the innate physical and biological properties of these tissues. Neox Wound Allograft is indicated for use as a wound covering for dermal ulcers and defects.

“The regenerative healing properties of Umbilical Cord and Amniotic Membrane delivered in a 1 mm thick allograft for superior handling and fixation, preserved using our patented Cryotek® process.”

Shelf life is two years from date of manufacture. Can be stored in a standard refrigerator or freezer at specified temperatures and specified times.

NuShield®Organogenesis, Inc., Canton, MA, USANuShield is a dehydrated placental allograft designed to protect and support healing in a variety of wound sizes and types.

“Organogenesis’ proprietary BioLoc™ processing method results in less manipulation than other dehydrated amniotic allografts. This process preserves the native structure of the amnion and chorion membranes, and maintains the spongy/intermediate layer, which is an abundant source of proteoglycans, glycoproteins and hyaluronic acid. Through this process, NuShield is also optimized to provide excellent strength, flexibility, and handling.”

Five-year shelf life

PalinGen® Membrane & HydromembraneAmnio Technology LLC, Phoenix, AZ, USAPalinGen Membrane and Hydromembrane are human allografts processed from healthy placental tissue. Placental tissue and membrane contain collagen substrates, growth factors, and ECM proteins recognized as part of the complex wound healing process.
  • “Resorbable.
  • Chorion free.
  • Amnion membrane.
  • Growth Factors.
  • Cytokines.
  • Amino Acids.
  • Extracellular Matrix Proteins.
  • Hyaluronic Acid.
  • Available in a variety of sizes.
  • Sterile.
  • Room temperature (15° C to 30° C).”
Restorigin™ Amniotic Tissue PatchesParametrics Medical, Leander, TX, USARestorigin Amniotic Tissue Patches is processed amniotic tissue and may be used on chronic wounds.“Due to its fetal origin, the innate regenerative capability of the tissue supports healing without adhesion or scar formation. Amniotic tissue acts an immune-privileged protective barrier during fetal development. Applied as an anatomical barrier, Restorigin offers mechanical protection while providing a regenerative tissue matrix with specific anti-inflammatory, anti-scarring, and anti-microbial properties. Restorigin’s proprietary process preserves the natural regenerative healing properties of the tissue and the growth factors responsible for promoting tissue formation without scarring.”
Revita®StimLabs, LLC, Roswell, GA, USARevita is an intact human placental membrane allograft that preserves all layers of the biologic tissue and maintains the physiologic 3D architecture of the natural barrier membrane. Revita provides the complete intact human placental membrane that is the physiologic tissue barrier naturally found in the body. This complete barrier containing amnion, intermediate layer and chorion retains many of the cytokines, growth factors, extracellular components, and cell communication signals the body uses to heal, protect, and grow tissues.“Using the Clearify™ processing method, Revita preserves all three layers of the amniotic membrane architecture.”
  • “Freeze-dried.
  • Never delaminated.
  • Preserves intermediate layer which contains hyaluronic acid and additional proteins.”
“Revita contains many essential cytokines and growth factors.”
WoundEx® Membrane and WoundEx FlowSkye Biologics, Inc., El Segundo, CA, USAWoundEx Membrane is a FastActing® dehydrated amniotic membrane skin substitute, available in thin amnion-only WoundEx® 45 and thick chorion-based WoundEx 200. WoundEx Flow is a flowable human placental connective tissue matrix skin substitute. It is provided as a concentrated fluid in the vial and can be extended with saline or anesthetic to provide greater coverage throughout the entire wound.

“WoundEx® Membrane Product Benefits:

Provides a native human placental BioActive® ECM, Various sizes minimize graft waste & cost, Adheres to wound bed without fixation, FastActing® Technology improves biologic response.”

Room temperature storage.

Xwrap® Amniotic Membrane-Derived AllograftApplied Biologics™, Scottsdale, AZ, USAXwrap is a Chorion-Free amniotic membrane wrap, cover or patch.Xwrap ECM is a chorion-free, non-crosslinked soft-tissue wound covering which acts as a natural scaffold for cellular migration, attachment, and proliferation. It is a natural alternative to cadaveric or animal-derived products.” “Xwrap® ECM is carefully processed to preserve the structural qualities of the amniotic membrane. Amnion is a native source of collagen types III, IV, V, and VII, as well as and fibronectin and laminin. It also contains fibroblasts and growth factors, modulates, cytokine and growth factor levels, and has been shown to have unique properties, including the ability to suppress pain, fibrosis, and bacteria, and to promote wound healing.”

ECM=extracellular matrix; kGy=kilogray

Table D-3Acellular/Dermal replacement from animal tissue source (21 products in this category)

ProductManufacturerManufacturer’s Product DescriptionManufacturer Claims
Architect® stabilized collagen matrixHarbor MedTech, Inc., Irvine, CA, USAAccording to the company, Architect is made from a widely available Xenograft commonly used in modern tissue heart valves and many other medical products. This tissue is homogeneous (over 95% type 1 collagen), durable, and porous.

“Architect is the only ECM stabilized by the BriDGE® process which prevents premature degradation by the excess MMPs and other proteases found in chronic wounds. Because Architect® remains intact, its ECM healing properties remain intact, including:

Helping to deactivate the inflammatory phase (which results in a reduction of MMPs, elastase, and other proteases).

Helping to promote the proliferative/healing phase. Preserving cell signaling factors to trigger and accelerate healing.

Providing an intact, durable scaffold for uninterrupted support of cellular growth and regeneration of native tissue.”

Freeze dried, stored at room temperature, long shelf life (actual length not reported)

Bio-ConneKt® Wound MatrixMLM Biologics, Inc., Alachua, FL, USA

Bio-ConneKt Wound Matrix is a collagen-based wound dressing for the local management of moderately to heavily exuding wounds. It is composed of reconstituted type I collagen that is stabilized, sterilized to SAL 10-6, and stored at room temperature.

Bio-ConneKt Wound Matrix is a sterile, conformable, and porous wound dressing made of reconstituted collagen derived from equine tendon. It is chemically crosslinked to provide resistance to enzymatic degradation. The dressing is provided sterile for single use only.

bio-ConneKt Wound Matrix is succeeding at chronic wound resolution when other treatments fail. Its unique properties deliver a robust medical solution that handles several complications of the chronic wound environment such as senescent cells, corrupt scaffolding, poor oxygen and blood supply in addition to incessant infection and abnormal inflammatory response.”
CollaWound collagen spongeCollamatrix Co., Ltd., Miaoli County, TaiwanCollawound collagen sponge website provides no information on the device.Collawound collagen sponge website provides no information on the device.
Cytal® wound matrixAcell, Inc., Columbia, MD, USACytal is composed of porcine urinary bladder matrix (UBM). These products maintain an intact epithelial basement membrane. Cytal devices are appropriate for acute wounds and chronic wounds.ACell’s wound management products are medical devices that maintain and support a healing environment by facilitating remodeling of site-appropriate, functional tissue. Store in a clean, dry environment between 15°C-35°C (59°F-95°F) in unopened and undamaged package.
Endoform™ dermal templateHollister Wound Care, Libertyville, IL, USAEndoform Dermal Template contains a naturally derived ovine collagen ECM that is terminally sterilized and may be considered more culturally acceptable than other animal-derived sources.

“Broad spectrum MMP reduction

  • Advanced care accessible to all clinicians.
  • Cost efficiency through weekly applications.”
Should be stored between

15ºC/59ºF-40ºC/104ºF in a clean and dry area.

Excellagen®Taxus Cardium Pharmaceuticals Group, San Diego, CA, USAExcellagen is collagen gel composed of formulated, 2.6% (26 mg/mL) fibrillar bovine dermal collagen (type 1) that is topically applied directly to the wound surface.

“Excellagen is a flowable, formulated homogenate of purified bovine Type I dermal collagen with collagen’s natural 3-dimensional fibrillar structure. Excelllagen promotes chemotaxis, cellular adhesion, migration and proliferation to stimulate granulation tissue formation. Excellagen is indicated for non-healing lower extremity ulcers in diabetic patients, and other dermal wounds and is intended for physician use during debridement procedures, which are used to promote and stimulate wound healing.”

Refrigerated 35-46°F (2-8°C) storage required

EZ Derm®Mölnlycke Health Care, Norcross, GA, USAEZ Derm is a porcine xenograft for partial skin loss injuries or as temporary cover.

“EZ Derm can be used for partial thickness skin loss injuries. EZ Derm can also be used as a temporary cover, or test graft, prior to autografting and as a protective covering over meshed autografts. EZ Derm maintains a protected moist wound environment during the healing process and aids the natural healing of the wound. It assists in controlling early wound exudates and assist in restoring water vapour function and heat loss. EZ Derm allows reepithelialization and growth of granulation tissue and reduces pain and fluid loss. It is a protective barrier by physical means and provide protection of the wound.”

Stored at room temperature.

Geistlich DermaGide™Geistlich Pharma North America Inc., Princeton, NJ, USAGeistlich Derma-Gide is a porcine, porous, resorbable, 3D matrix designed specifically for the management of wounds.Geistlich Derma-Gide is an advanced wound matrix that has been specifically engineered to support angiogenesis and wound closure. Intended to be used for the management of wounds including: partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic venous ulcers, surgical wounds and trauma skin wounds. The device inactivates matrix metalloproteinases (MMP), while supporting migration and proliferation of fibroblasts, keratinocytes and endothelial cells where they are needed.
Helicoll™EnColl Corp., Fremont, CA, USAHelicoll is an acellular bovine collagen matrix free of contaminants.

Helicoll reduces wound pain, accelerates the healing rate, reduces scarring, reduces hospital stay, and reduces treatment cost.

Shelf life of 3 years at room temperature.

Integra® Matrix Wound Dressing; originally Avagen wound dressing.Integra LifeSciences Corp., Plainsboro, NJ, USAIntegra Wound Matrix is a wound care device composed of a porous matrix of cross-linked bovine tendon collagen and glycosaminoglycan. The collagen-glycosaminoglycan biodegradable matrix provides a scaffold for cellular invasion and capillary growth. Integra Wound Matrix provides coverage over exposed bone, tendon, cartilage, and joints.

“A single layer collagen matrix that supports a healing environment for wounds.”

Room temperature storage with a 24-month shelf life.

MicroMatrix®ACell, Inc., Columbia, MD, USAMicroMatrix is composed of a porcine-derived extracellular matrix known as urinary bladder matrix. The device is supplied in a particle form in units up to 1,000 mg and packaged in a glass vial and peel-open pouch. The device is terminally sterilized using electron beam irradiation. ACell’s Wound Management Products are medical devices that maintain and support a healing environment by facilitating remodeling of site-appropriate, functional tissue. Composed of naturally occurring urinary bladder matrix (UBM), MicroMatrix maintains an epithelial basement membrane and is appropriate for acute wounds and chronic wounds.“ACell’s Wound Devices:
  • Contain epithelial basement membrane.
  • and numerous collagens.
  • Non-crosslinked wound management scaffold.
  • Complement standard of care.”
Store in a clean, dry environment between 15°C-35°C (59°F-95°F)
Miroderm®Miromatrix Medical, Inc., Eden Prairie, MN, USAMiroderm is a non-crosslinked acellular wound matrix derived from porcine liver for the management of wounds. 1 surface of Miroderm retains the native liver capsule (an epithelial basement membrane), and the opposite surface is composed of open liver matrix. Originally Miromatrix Wound Matrix.

“The first-and-only wound matrix derived from porcine liver, Miroderm® retains an intact extracellular matrix with unique properties.”

Stored at room temperature.

Ologen™ Collagen MatrixAeon Astron Europe B.V.Ologen Collagen Matrix is a dry scaffold containing a connected porous structure of 10-300 μm diameter made of cross-linked lyophilized porcine type I atelocollagen (≥90%) and glycosaminoglycans (GAG) (≤10%).

No website is devoted to this product for treating chronic wounds.

Stored at room temperature with a shelf life of 36 months.

Kerecis™ Omega3 Wound (originally Merigen wound dressing)Kerecis, Arlington, VA, USAKerecis MariGen Wound Dressing is processed fish dermal matrix composed of fish collagen and is supplied as a sterile, intact, or meshed sheet.Kerecis produces tissue-based, skin-substitute products for use in surgery and for treating wounds. Compared to other tissue-transplant products, the Kerecis Omega3 fish skin is cost-effective, offers improved clinical performance, reduces the risk of disease transfer, and has no cultural constraints on usage.” Store at 25°C (no more than 40°C).
Oasis® Wound MatrixSmith & Nephew, Inc., Fort Worth, TX, USAOasis Matrix products are naturally derived scaffolds of ECM, composed of porcine small intestinal submucosa (SIS), which help support the body’s own wound closure mechanisms.“Provides pathways for cellular migration and vascular growth.” Storage at room temperature with a shelf life of 2 years.
PriMatrix® Dermal Repair ScaffoldIntegra LifeSciences Corp., Plainsboro, NJ, USAAccording to the company, PriMatrix Dermal Repair Scaffold is a unique scaffold for the management of wounds. Derived from fetal bovine dermis, the acellular dermal matrix is designed to provide an environment to support cellular repopulation and revascularization processes for wound healing. PriMatrix contains type III collagen found in fetal dermis and believed to be active in developing and healing tissues.

“The PriMatrix proprietary processing technology preserves the beneficial properties of the natural dermal collagen fibers and generates a tissue matrix free of contaminants and artificial chemical crosslinks. When applied to the patient’s wound PriMatrix rapidly fills with blood, binding both cells and growth factors. The enriched dermal collagen fibers support cellular repopulation and revascularization processes critical in wound healing.”

Store at room temperature.

Puracol® and Puracol® Plus Collagen Wound DressingsMedline Industries, Northfield, IL, USAComposed of 100% bovine collagen.

“Our Puracol wound dressings (Puracol Plus, Puracol Plus Ag+ and Puracol Ultra Powder) promote natural healing with type I 100% native collagen. Our exclusive, gentle manufacturing technology preserves the collagen’s natural structure, resulting in dressings that provide more collagen to a wound for a longer period of time.”

“Native collagen wound dressings can be used to manage chronic wounds. The addition of collagen to the wound bed may reduce excess MMP activity to promote the wound healing cycle.”

PuraPly® Antimicrobial (PuraPly® AM) Wound Matrix (formally called FortaDerm)Organogenesis, Inc., Canton, MA, USAPuraPly Antimicrobial Wound Matrix (PuraPly AM) consists of a collagen sheet coated with 0.1% polyhex-methylenebiguanide hydrochloride (PHMB) intended for the management of wounds. PuraPly AM is supplied dry in sheet form. The device is packaged in sterile, sealed single pouches.

“PuraPly AM utilizes a purified native collagen matrix embedded with the antimicrobial [PHMB], a broad spectrum antimicrobial. It is this combination of native collagen and PHMB that helps manage the reformation of biofilm while supporting healing across a wide variety of wound types, regardless of severity or duration.”

Stored in a clean, dry location at room temperature.

Talymed®Marine Polymer Technologies, Inc., Burlington, MA, USATalymed advanced matrix is composed of shortened fibers of poly‑N‑acetyl glucosamine isolated from microalgae.
  • “86% of patients experienced complete wound healing.
  • Non-immunogenic.
  • Easy to apply.
  • Store at room temperature for up to 3 years.”
TheraForm™ Standard/Sheet Absorbable Collagen MembraneSewon Cellontech Co., Seoul, KoreaTheraForm is an absorbable and biocompatible implant to enhance tissue regeneration and can be used with human cell or tissue-specific ingredients. It is a sterile, pliable, porous scaffold made of biocollagen for wound dressing, soft-tissue regeneration scaffold agent, periodontal tissue repair agent, and the control of bleeding.“Absorbable collagen membrane is a sterile, pliable, porous surgical wound dressing. Standard and Sheet types are ideal wound healing biomatrix.”

ECM=extracellular matrix; MMP= matrix metalloproteinases

Table D-4Acellular/Dermal replacement from synthetic materials (2 products in this category)

ProductManufacturerManufacturer’s Product DescriptionManufacturer Claims
Hyalomatrix® tissue reconstruction matrixAnika Therapeutics, Bedford, MA, USAHyalomatrix is a bilayered, sterile, and flexible advanced wound care device. It is ideally suited for a range of wounds, including pressure ulcers, diabetic foot ulcers, and deep second-degree burns. Hyalomatrix is a nonwoven pad composed of a wound contact layer made of a derivative of hyaluronic acid (HA) in fibrous form with an outer layer composed of a semipermeable silicone membrane. The wound contact layer is biodegradable, and it acts as a 3D scaffold for cellular invasion and capillary growth. The silicone layer controls water vapor loss and provides protective coverage of the wound.

“The Hyalomatrix Advantage:

Conveniently conformable to a variety of wound sizes. Minimizes risk of bacterial contamination with protective and flexible covering.

Simplifies monitoring–wound can be inspected without matrix removal.

Controls water vapor loss with semipermeable layer.” Store at room temperature.

Restrata™Acera Surgical, Inc., St. Louis, MO, USA

Restrata is a fully synthetic electrospun wound dressing composed of randomly oriented nanofibers that create a highly porous scaffold for cellular infiltration and vascularization during wound repair. Its structure was engineered to be similar to that of native extracellular matrix, 1 of the key building blocks of newly forming tissue. The fibers comprising Restrata Wound Matrix are produced from polyglactin 910 and polydioxanone, both bioabsorbable polymers.

Product website not available

Table D-5Acellular/Dermal replacement from combined natural and synthetic materials (2 products in this category)

ProductManufacturerManufacturer’s Product DescriptionManufacturer Claims
Integra® Bilayer Matrix Wound DressingIntegra LifeSciences Corp., Plainsboro, NJ, USAIntegra Bilayer Wound Matrix is an advanced wound care device composed of a porous matrix of cross-linked bovine tendon collagen and glycosaminoglycan and a semi-permeable polysiloxane (silicone layer). Promoted for inpatient use.

“The semi-permeable silicone membrane controls water vapor loss, provides a flexible adherent covering for the wound surface and adds increased tear strength to the device. The collagen-glycosaminoglycan biodegradable matrix provides a scaffold for cellular invasion and capillary growth.”

Room temperature with a 24-month shelf life.

Integra® Dermal Regeneration Template and Integra Omnigraft Regeneration TemplateIntegra LifeSciencesIntegra Dermal Regeneration Template (Integra Template) has 2 layers: a thin outer layer of silicone and a thick inner matrix layer of pure bovine collagen and glycosaminoglycan (GAG). Both collagen and GAG are normal components of human skin. In Integra, the collagen is obtained from bovine tendon collagen, and the glycosaminoglycan is obtained from shark cartilage.

“Silicone layer: Enables immediate wound closure. Controls fluid loss. Provides mechanical protection. Provides a bacterial barrier. Water vapor transmission rate similar to that of normal skin.” “3-Dimensional matrix layer: Cross-linked collagen and glycosaminoglycan. Functions as an extracellular matrix. Promotes cellular growth and collagen synthesis. Biodegrades while being replaced by autologous dermal tissue.”

Room temperature with a 24-month shelf life.

Table D-6Acellular/Epidermal and Dermal replacement from human placental membrane (1 product in this category)

ProductManufacturerManufacturer’s Product DescriptionManufacturer Claims
AltiPly®Aziyo Biologics, Silver Spring, MD, USALyophilized Placental Membrane. The growth factor-rich matrix, with an outer basement membrane and epithelial layer, immediately serves as a scaffold for reepithelialization.

AltiPly is opaque, and thicker than other grafts. The dry graft is flexible and easy to handle. What you can’t see is the benefit of our proprietary processing on preserving the quality of the matrix. The growth factor-rich matrix, with an outer basement membrane and epithelial layer, immediately serves as a scaffold for reepithelialization.” “Supports wound closure of chronic diabetic foot ulcers (DFU), venous leg ulcers (VLU) and pressure wounds.”

“Proprietary processing improves growth factor levels over dehydration methods.”

Table D-7Cellular/Dermal replacement from human placental membrane (4 products in this category)

ProductManufacturerManufacturer’s Product DescriptionManufacturer Claims
Affinity® Human Amniotic AllograftOrganogenesis, Inc., Canton, MA, USAAffinity is a fresh amniotic membrane aseptically processed and hypothermically preserved using AlloFresh®, a proprietary storage system. The product is not dehydrated or frozen. Affinity can be applied to chronic wounds, such as diabetic foot ulcers, venous leg ulcers, and pressure ulcers.

Affinity is the only fresh amniotic membrane that contains: viable cells (including stromal cells, fibroblasts, and epithelial cells), angiogenenic, regenerative and anti-inflammatory growth factors and cytokines, and a native extracellular matrix and multiple important [extracellular matrix] proteins.”

“Organogenesis’ proprietary AlloFresh processing method allows for the fresh, hypothermic storage of the amniotic tissue while retaining its structural integrity, viability, and native benefits.”

All fresh allografts must be maintained at refrigerated temperature (between 1°C and 10°C) during storage.

FlōGraft® Amniotic Fluid-Derived AllograftApplied Biologics, Scottsdale, AZ, USAFlōGraft is chorion-free allograft composed of amnion and amniotic fluid derived from prescreened, live, healthy donors. Amniotic membrane and fluid act as a biologic system that ensures symmetrical structure development and growth, cushions and protects the embryo, has a significant defensive role as a part of the innate immune system, and protects the fetus by maintaining consistent pressure and temperature. FlōGraft retains this protective function as a versatile and manageable liquid allograft and is indicated as an additive in several general surgical applications, including soft-tissue defects, soft-tissue trauma, tendinitis, tendinosis, chronic wounds, and localized inflammation.FlōGraft is carefully processed to preserve the structural qualities of the amniotic membrane yet allow for the allograft to be implanted using a 22-23 gauge needle. Amnion is a native source of collagen types III, IV, V, and VII, as well as and fibronectin and laminin. It also contains fibroblasts and growth factors, modulates, cytokine, and growth factor levels, and has been shown to have unique properties, including the ability to suppress pain, fibrosis, and bacteria and to promote wound healing. These qualities may provide an ancillary benefit to the primary purpose of FlōGraft human allograft as a soft-tissue defect filler.
Grafix®Osiris Therapeutics, Inc., Columbia, MD, USAGrafix (cryopreserved placental membrane) is a cryopreserved amnion or chorion matrix retaining the extracellular matrix, growth factors, and endogenous neonatal mesenchymal stem cells, fibroblasts and epithelial cells of the native tissue.“Designed for application directly to acute and chronic wounds. Flexible, conforming cover that adheres to complex anatomies.” Minimum two year shelf life and should be stored frozen at -80°C.
GrafixPL PrimeOsiris TherapeuticsGrafixPL Prime (lyopreserved placental membrane) is a lyopreserved amnion matrix retaining the extracellular matrix, growth factors, and endogenous neonatal mesenchymal stem cells, fibroblasts and epithelial cells of the native tissue

“Both cryopreserved and lyopreserved products [Grafix Prime and GrafixPL Prime] retain the viable epithelial cells, fibroblasts, and mesenchymal stem cells found in fresh placental amnion. The extracellular matrix, including collagen, elastin, fibronectin, and laminin, is preserved in the native architecture within both products. The cytokines and growth factors for fresh amnion are preserved in both.”

Stored at room temperature

Table D-8Cellular/Dermal replacement from combined natural and synthetic materials (1 product in this category)

ProductManufacturerManufacturer’s Product DescriptionManufacturer Claims
Dermagraft®Organogenesis Inc., Canton, MA, USA"Dermagraft is a cryopreserved human fibroblast derived dermal substitute; it is composed of fibroblasts, extracellular matrix, and a bioabsorbable scaffold. Dermagraft is manufactured from human fibroblast cells derived from donated newborn foreskin tissue. During the manufacturing process, the human fibroblasts are seeded onto a bioabsorbable polyglactin mesh scaffold. The fibroblasts proliferate to fill the interstices of this scaffold and secrete human dermal collagen, matrix proteins, growth factors and cytokines, to create a three-dimensional human dermal substitute containing metabolically active, living cells. Dermagraft does not contain macrophages, lymphocytes, blood vessels, or hair follicles."

“Dermagraft helps to restore the compromised DFU [diabetic foot ulcer] dermal bed to facilitate healing by providing a substrate over which the patient’s own epithelial cells can migrate to close the wound.”

Must be stored continuously at -75°C ±10°C.

Table D-9Cellular/Epidermal and Dermal replacement from human skin (2 products in this category)

ProductManufacturerManufacturer’s Product DescriptionManufacturer Claims
SkinTE™PolarityTE, Salt Lake City, UTSkinTE is regenerative full thickness, functional skin. After a small full-thickness tissue sample from a patient is sent to PolarityTE, the construct will be created and returned for application on or in the same patient.SkinTE is a first-of-its-kind entirely autologous product for skin repair, reconstruction, replacement, supplementation and regeneration. SkinTE has resulted in regenerative full-thickness healing of skin with all its layers (epidermis, dermis and hypodermis) and its appendages (hair follicles, glands, etc.). SkinTE is for the repair, reconstruction and replacement of full-thickness skin. SkinTE can be used by physicians and other medical providers to repair, reconstruct, replace or supplement a patient’s damaged or missing skin tissue. It is currently being used by providers for the treatment of acute and chronic wounds.
Theraskin®LifeNet Health, Virginia Beach, VA, USA (procurement and processing) Solsys Medical, Newport News, VA, USA (distribution)According to the manufacturer, TheraSkin is a cryopreserved human, living, split-thickness allograft that contains living cells, growth factors, and an architecturally preserved human ECM scaffold that vascularizes. Around 7-14 days after application, the epidermal cells and any antigenic components are removed, but the dermal scaffold and the matrix is retained. The tissue is safely procured according to industry standards developed by AATB within 24-hours postmortem from an organ donor. The donor criteria for TheraSkin surpass those required by AATB and TheraSkin maintains a proven track record of zero disease transmission. When procured, the allograft is washed with a series of antibiotics and cryopreserved using a proprietary cryopreservation process.

“Application of TheraSkin—a real human skin allograft—can replace damaged skin and can assist in healing most chronic wounds, even wounds that have not progressed for many months and have failed to heal with other therapies.”

“TheraSkin is a biologically active, cryopreserved human skin allograft, composed of living cells, fibroblasts and keratinocytes, and a fully developed extracellular matrix (ECM) in its epidermal and dermal layers. TheraSkin provides, upon application, a supply of growth factors/cytokines, and a robust collagen scaffold to jumpstart healing in a chronic wound.”

AATB=the American Association of Tissue Banks

Table D-10Cellular/Epidermal and Dermal replacement from combined human and animal sources (1 product in this category)

ProductManufacturerManufacturer’s Product DescriptionManufacturer Claims
Apligraf®Organogenesis Inc., Canton, MA, USAApligraf is a living cell-based product for chronic venous leg ulcers and diabetic foot ulcers. Apligraf is supplied as a living, bilayered skin substitute. The lower dermal layer combines bovine type 1 collagen and human fibroblasts (dermal cells), which produce additional matrix proteins. The upper epidermal layer is formed by promoting human keratinocytes (epidermal cells) first to multiply and then to differentiate to replicate the architecture of the human epidermis..

Apligraf plays an active role in healing by providing to the wound living cells, proteins produced by the cells, and collagen, which are important for healing.”

Should be kept in its tray on the medium in the sealed bag under controlled temperature 68°F-73°F (20°C-23°C) until ready for use

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