Autografting is a surgical procedure to transplant healthy skin (donor skin) from another part of the participant's own body (donor site) to the burned part. Autografting is the usual treatment for full-thickness (FT) burns. It works to close the wound, but can cause other problems: * Donor sites are painful, can become infected or scarred, or can even become FT wounds themselves * Treatment problems can require more grafting * Additional surgery increases risk of medical problems caused by the treatment Stratatech is trying to find a safe and effective treatment option for severe burns that uses less donor skin. All participants in this study received meshed autograft on one part of their burn (AG Tx). They received more widely meshed than AG Tx site autograft with a StrataGraft covering (SOMA Tx) on a different part of their burn.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Control treatment that is meshed autograft alone applied to a burn area.
Meshed autograft applied to the burn area and covered with StrataGraft.
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
Tampa General Hospital / University of South Florida
Tampa, Florida, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Stony Brook University
Stony Brook, New York, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Number of Treatment Sites With Complete Wound Closure Without Additional Autografting at Month 2
Confirmed complete wound closure was defined as complete skin re-epithelialization without drainage confirmed at 2 visits at least 2 weeks apart but no later than Week 20. Complete wound closure was considered to have occurred at the earlier of the 2 observations of complete skin re-epithelialization without drainage. The number of treatment sites with complete wound closure without additional autografting at Month 2 was reported.
Time frame: At Month 2
Number of Participants With Durable Wound Closure of Study Treatment Sites Without Additional Autografting at Month 12
Durable wound closure is defined as persistence of closure, maintained for at least 3 months after the initial observation of closure.
Time frame: At Month 12
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