SkinTE is a fully autologous (from the patient for the patient), homologous (utilized as a skin substrate) cutaneous construct which should only be used by skilled medical professionals.
SkinTE is intended to be used by physicians or other appropriate healthcare providers for homologous uses of skin tissues/integument. Patients who have suffered from an event, disease, process or acquired deficit that results in the functional loss or void of skin/integument systems can use SkinTE as an adjunct and/or in place of split-thickness skin grafting full-thickness grafting temporizing skin coverage and/or skin substitute products.
SkinTE is regulated by the FDA as an HCT/P solely under Section 361 of the Public Health Service Act and 21 CFR 1271. The FDA has specific regulations governing HCT/Ps. HCT/Ps that meet the criteria for regulation solely under Section 361 of the Public Health Service Act and 21 CFR 1271 (361 HCT/Ps) are not subject to pre-market clearance or approval requirements, but are subject to post-market regulatory requirements.
SkinTE is processed and marketed in accordance with the FDA's requirements for human tissue and current good tissue practices (21 CFR 1271).
Important Safety Information
Poor general medical condition or any pathology that would limit the blood supply and compromise healing, as well as nonvascular surgical sites, should be considered when selecting patients for SkinTE, as such conditions may compromise successful outcomes or lead to sub-optimal results.
Whenever clinical circumstances require implantation in a site that is contaminated or infected, appropriate local and/or systemic anti-infective measures must be taken. Unused or expired tissue product should be discarded according to local, state, federal and institutional requirements. Utilization of the SkinTE construct, process and/or technology is limited to healthcare professionals and facilities that are capable of handling such tissue products.
Proper aseptic procedural and/or surgical handling is mandatory when using SkinTE. Failure to ensure proper aseptic technique may result in contamination of the tissue product and wound bed. Contamination of the tissue product and/or wound bed due to failure to ensure aseptic technique could result in local, regional, or systemic infection, partial or complete failure of graft take, healing, and/or regeneration, serious injury, and/or death. Failure to follow instructions may lead to sub-optimal outcomes and/or product failure.
Potential adverse effects may include but are not limited to the following: local tissue, wound bed, regional tissue, or systemic infection, hypersensitive, allergic, or other immune response to the product or trace amounts of antibiotic retained from primary harvest, deleterious effects on potential surrounding or adjacent autologous, allogeneic, or xenogeneic grafts, skin substitutes, or other reconstructions including infection and/or failure of adjacent grafted material to take and heal, requirement for further surgical operations(s) and/or debridement, or death.