Human Skin Allografts
Last updated on 8/26/18 | First published on 9/18/17 | Literature review current through Nov. 2024
[cite]
(2018).
"Human Skin Allografts". In
(Eds.)
, WoundReference.
Available from: https://woundreference.com/app/topic?id=ctp-human-skin-allografts. Retrieved on 12/18/24.
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
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CGS Administrators, LLC et al. LCD: Wound Application of Cellular and/or Tissue Based Products (CTPs), Lower Extremities (L36690) . 2022;.
Topic 17 Version 1.0
SUBTOPICS
Alloderm Tissue Matrix is a human skin allograft that can be used for wound coverage
CODING, COVERAGE AND REIMBURSEMENTThis section currently focuses primarily on Medicare. It may be expanded in the future to include information on private insurers as well.
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
CODING, COVERAGE AND REIMBURSEMENTThis section currently focuses primarily on Medicare. It may be expanded in the future to include information on private insurers as well.
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
RELATED TOPICS
Allogeneic Matrices are cellular and/or tissue products usually derived from human neonatal fibroblasts of the foreskin, and may contain metabolically active or regenerative components
Composite Matrices are a type of cellular and/or tissue products derived from human keratinocytes and fibroblasts supported by a scaffold of synthetic mesh or xenogeneic collagen.
Skin Substitute:Duration of ulcer - approximately 89 weeksWound free of infection, osteomyelitis, surrounding cellulitis, tunnels/tracts, necrotic tissue - yesInitial Application/Reapplication - 3rd applicationSkin substitute used - Grafix PrimeMethod of fixation - Mepitel, steristripsLot # - A160300Unit # - 16003Part # - PS60013Expiration date - 6/14/18
