Safety and Efficacy of realSKIN® to Provide Complete Wound Closure of Burn Wounds as an Alternative to Autografting

This study is a Phase 3 open-label, interventional, controlled, randomized, multicenter clinical trial. It is comprised of an estimated 50 men and women aged 18 years and older who experienced severe and extensive, mixed-depth and full-thickness thermal burn wounds up to 50% TBSA requiring surgical excision and skin grafting for which autografting is clinically indicated. The comparator control for the study is autografting, the current standard of care procedure for the treatment of severe burns, which involves the removal of healthy skin from an uninjured site on the patient and using it to cover the original burn wound to achieve complete and durable wound closure. After surgical preparation of the wound bed, subjects will receive approximately 100 square centimeters of realSKIN at a predesignated wound site and separately, autografting at an alternate site, per the standard of care, in accordance with the randomization schedule. Thus, each patient represents both the experimental and control group, to be evaluated in isolated but comparable settings. The use of an intra-patient comparator allows for a matched control to eliminate significant underlying differences, including immunologic, physiologic, and scarring variable inherent in this patient population that may impact wound healing at the treatment sites. After surgical excision to remove nonviable tissue or previously applied temporary wound dressings, two wound treatment sites of comparable area and depth will be identified. Treatment assignment will be randomized to receive either realSKIN or a surgically harvested autograft. The pre-identified treatment sites must each be a wound area of comparable depth that is not contiguous (e.g., "sharing a common border or touching") to ensure the interpretability of the efficacy results. Additionally, two unaffected areas of the patient's intact, healthy skin will be prospectively identified to provide sources of autografts for the control site and realSKIN treatment site (e.g., patient skin harvest sites.) These pre-identified regions may be in the same anatomic area or from two separate but comparable areas, depending on the amount of intact native patient skin available.