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Human Skin Allografts

Human Skin Allografts

Human Skin Allografts

OVERVIEW

Human Skin Allografts are bioengineered from human skin components and human tissue which have had intact cells removed or treated to avoid immunologic rejection. They are available in different forms to allow scaffolding, soft tissue filling, growth factors and other bioavailable hormonal or enzymatic activity. [1]

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REFERENCES

  1. Administrators, CGS et al. Local Coverage Determination (LCD) - Wound Application of Cellular and/or Tissue Based Products (CTPs), Lower Extremities (L36690) . 2016;.
Topic 17 Version 1.0

Subtopics

Alloderm Tissue Matrix is a human skin allograft that can be used for wound coverage

CLINICALIndicationsFor homologous use in:Burns, skin cancer treatments, scar revisions, venous ulcers, diabetic foot ulcers, pressure (decubitus) ulcers, vascular (arterial) ulcers FDARegulated under PHS 361 [21 CFR

CLINICALIndicationsFor homologous use on any skin defect and is appropriate for use in traumatic and chronic wounds, including those where substructures such as bone, ligament, nerve or muscle are exposed. FDARegulated under PHS 361 [21 CFR 1270 & 1271]: Human cells, tissues, and cellular and tissue-based products. Creates a unified registration and listing system for establishments that manufacture HCT/Ps and establishes donor eligibility, current good t

CLINICALIndicationsFor homologous use on any skin defect and is appropriate for use in traumatic and chronic wounds, including those where substructures such as bone, ligament, nerve or muscle are exposed. FDARegulated under PHS 361 [21 CFR 1270 & 1271]: Human cells, tissues, and cellular and tissue-based products. Creates a unified registration and listing system for establishments that manufacture HCT/Ps and establishes donor eligibility, current good t

CLINICALIndicationsFor homologous use on any skin defect and is appropriate for use in traumatic and chronic wounds, including those where substructures such as bone, ligament, nerve or muscle are exposed. FDARegulated under PHS 361 [21 CFR 1270 & 1271]: Human cells, tissues, and cellular and tissue-based products. Creates a unified registration and listing system for establishments that manufacture HCT/Ps and establishes donor eligibility, current good t

CLINICALIndicationsDermaCell is a decellularized human dermis allograft designed for reconstruction surgical applications including chronic nonhealing wounds.Breast reconstruction FDARegulated under PHS 361 [21 CFR 1270 & 1271]: Human cells, tissues, and cellular and tissue-based products. Creates a unified registration and listing system for establishments that manufacture HCT/Ps and establishes donor eligibility, current good tissue

CLINICALIndicationsDermaPure® Decellularized Dermal Allogra provides a scaffold for the body’s repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument. FDARegulated under PHS 361 [21 CFR 1270 & 1271]: Human cells, tissues, and cellular and tissue-based products. Creates a unified registration and listing sys

FlowerDerm™ Acellular Dermal Allograft is intended to be used as a skin substitute for wound covering. It is commonly used for supplemental support and reinforcement of tendons.

CLINICALIndicationsVenous Stasis UlcersDiabetic Foot UlcersFull Thickness UlcersMohs Surgery SitesSkin Graft Donor SitesAreas of DermabrasionPartial Thickness BurnsPartial Thickness WoundsTemporary Coverage for Exposed Abdominal Viscera including Small Bowel and LiverExposed Peric

CLINICALIndicationsFor repair or replacement of damaged or inadequate integumental tissue, such as diabetic foot ulcers, venous leg ulcers, pressure ulcers, or for other homologous uses of human integument FDARegulated under PHS 361 [21 CFR 1270 & 1271]: Human cells, tissues, and cellular and tissue-based products. Creates a unified registration and listing system for establishments that manufacture HCT/Ps and establishes donor eligibility, current good t

CLINICALIndicationsFor homologous use in supporting the body’s repair of damaged or inadequate tissue, such as deep dermal wounds or diabetic ulcers. FDARegulated under PHS 361 [21 CFR 1270 & 1271]: Human cells, tissues, and cellular and tissue-based products. Creates a unified registration and listing system for establishments that manufacture HCT/Ps and establishes donor eligibility, current good tissue practice, and other procedures to prevent the intr

CLINICALIndicationsMatrix HD is a sterile acellular human dermis designed for reconstructive surgery and for treating chronic skin wounds FDARegulated under PHS 361 [21 CFR 1270 & 1271]: Human cells, tissues, and cellular and tissue-based products. Creates a unified registration and listing system for establishments that manufacture HCT/Ps and establishes donor eligibility, current good tissue practice, and other procedures to prevent the introduction, tr

CLINICALIndicationsFor homologous use in: Rotator Cuff, Anterior Shoulder Capsule, Flex/Extensor Tendon, Ulnar Collateral Ligament, Achilles Tendon, Lateral Ankle Complex, Chronic Diabetic Foot Ulcer. FDARegulated under PHS 361 [21 CFR 1270 & 1271]: Human cells, tissues, and cellular and tissue-based products. Creates a unified registration and listing system for est

Repriza is an acellular dermal matrix created from dermal cadaver tissue. See clinical, coding and reimbursement information.

CLINICALIndicationsFor homologous use in diabetic foot ulcers, venous stasis ulcers, and pressure ulcers. FDARegulated under PHS 361 [21 CFR 1270 & 1271]: Human cells, tissues, and cellular and tissue-based products. Creates a unified registration and listing system for establishments that manufacture HCT/Ps and establishes donor eligibility, current good tissue practice, and other procedures to prevent the introduction, transmission, and spread of commun