SkinTE

Supplied in sterile syringe.

SkinTE is a fully autologous homologous cutaneous construct that should only be used by licensed medical professionals. SkinTE is intended to be used by physicians or other appropriate health care providers for homologous uses of the skin and integumentary system. Patients who have suffered from an event, disease, process or who have an acquired defect that has resulted in the functional loss or absence of the skin and integumentary system 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. Each package of SkinTE is intended for autologous use that is patient-specific and for a single application.

SkinTE is for autologous use only. Aseptic technique is mandatory at all times when harvesting skin as well as during the deployment of SkinTE. Only use occlusive, non-meshed, non-adherent, non-absorbent primary dressings over the SkinTE treated wound bed (e.g., silicone). Do not use SkinTE if the patient identification number (PIN) and the patient name on the product does not match the patient identification number and name for the specific patient. Do not use antibiotics listed on the SkinTE packaging in patients who are allergic, may be hypersensitive or have had a previous reaction to them. Do not use SkinTE if the packaging or related contents appear to have been damaged, manipulated or opened prior to harvest or deployment. Do not use SkinTE if there is questionable contamination of the materials. Do not use SkinTE if the temperature tracker depicts a violation of the temperature boundaries (outside of 1C-10C). Do not use SkinTE if the expiration date on tissue product has passed. Do not use SkinTE if the tissue product has leaked outside of its intended carriers. Do not re-use SkinTE, as the product is packaged for deployment and is intended for single-use application. Cryopreservation: SkinTE active units can be cryopreserved for later autologous use following current good tissue practices (cGTP) processing, but this request must be communicated to and confirmed by PolarityTE prior to processing. Do not freeze SkinTE, it should be refrigerated upon receipt between 1C-10C (34F-50F) if not intending to use the SkinTE construct the same day as arrival. Do not sterilize SkinTE, as the product contains living autologous, homologous tissue for a specific indicated patient. Sterilization of the tissue product will result in death of the cells and tissues and prevent appropriate biological function.
Patients with multiple comorbidities, who are severely immunocompromised, who are in poor general health or who have any condition that could compromise recipient site vascularity and wound healing should be carefully evaluated prior to using SkinTE. Such conditions may prevent successful outcomes or lead to suboptimal results. Whenever clinical circumstances require use in a site that is contaminated or infected, appropriate local and/or systemic anti-infective measures must be taken. If there are signs of compromise of the tamper evident seal, please contact Clinical Operations immediately to determine if SkinTE can be transplanted or must be discarded. Unused or expired tissue product should be discarded according to local, state, federal and institutional regulations. 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 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 suboptimal outcomes, product failure and/or patient harm.

An "adverse reaction" for SkinTE, which is registered with the United States Food and Drug Administration as a human cells, tissues and cellular and tissue-based product (HCT/P) regulated solely under Section 361 of the Public Health Service Act, is defined as a noxious and unintended response to any HCT/P for which there is a reasonable possibility that the HCT/P caused the response (21 CFR 1271.3(y)). Whenever an HCT/P recipient experiences an unintended response, there may be multiple possible causes. Nevertheless, if one of the reasonable possibilities is that the HCT/P caused the response, then this would meet the definition of "adverse reaction." Adverse reactions potentially attributable to SkinTE must be reported promptly to PolarityTE. Adverse reactions can be reported to the Medical Affairs Division by calling 1-800-476-6057 or emailing medicalaffairs@polarityte.com.