Safety and Efficacy of realSKIN® to Provide Complete Wound Closure of Burn Wounds as an Alternative to Autografting
Trial Parameters
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Brief Summary
To evaluate the safety and efficacy of realSKIN® to provide complete wound closure of mixed-depth, full-thickness burn wounds as an alternative treatment to autografting.
Eligibility Criteria
Inclusion Criteria: 1. The subject, or the subject's legally authorized representative (LAR), provides written informed consent to participate in this study 2. Males or females age greater than or equal to 18 years old 3. Total Burn Surface Area (TBSA) \<50% to include mixed depth and full-thickness burn wounds as defined as "primarily full-thickness (FT) and deep-partial (DPT) thermal burns (e.g. \>60% of the total burn area should be FT and DPT) before debridement", and full-thickness burns for which surgical intervention is clinically indicated 4. Having a mixed depth thermal burn wound including full thickness requiring skin grafting 5. Biological females must have a negative serum pregnancy test at Screening and must not be nursing 6. All subjects must agree to use a protocol-approved method of contraception for a minimum of 3 months following realSKIN placement, which includes a barrier method plus one or more of the following: * Hormonal contraceptives (e.g., birth control pills