A Phase III Open-Label, Multicenter, Randomized, Controlled Clinical Trial to Evaluate the Safety and Efficacy of realSKIN® to Provide Complete Wound Closure of Mixed-Depth, Full-Thickness Burn Wounds as an Alternative to Autografting
XenoTherapeutics, Inc.
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.
Description
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…