About 70 participants will be enrolled. They will have complex skin defects because of burns caused by heat. The burns will: * be on 3-49% of the participant's total body surface area (TBSA) * require surgery for skin replacement * include intact dermal elements The burns are called deep, partial-thickness thermal burns because the skin was damaged by heat but still has some dermis that was not damaged. The dermis is the layer of skin under the outer layer (epidermis). It is the thickest layer of the skin that provides strength and flexibility to the skin. All patients will receive both treatments, but on different areas of their burns. Their wounds will not be compared to other patients. One treatment area on their own body will be compared to the other one. This will help to find out if StrataGraft is safe and effective for deep partial thickness burns. It will also see if StrataGraft might help healing enough to use it instead of the patient's own healthy skin to repair the damage.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
71
StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®).
The current standard of care procedure for the treatment of severe burns. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original burn wound.
University of South Alabama Medical Center
Mobile, Alabama, United States
Arizona Burn Center at Maricopa Medical Center
Phoenix, Arizona, United States
Universtiy of California - Irvine Health Regional Burn Center
Orange, California, United States
UC Davis
Sacramento, California, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
University of Florida Health Shands Burn Center
Gainesville, Florida, United States
Tampa General Hospital - Regional Burn Center
Tampa, Florida, United States
University of Iowa
Iowa City, Iowa, United States
Baton Rouge Medical Center
Baton Rouge, Louisiana, United States
University Medical Center
New Orleans, Louisiana, United States
...and 6 more locations
Percent Area of Treatment Sites Requiring Autografting by Month 3
Percent area autografted by Month 3 is the sum of the percent areas at each study session/visit, up to and including Study Session 7/Month 3 (± 14 d).
Time frame: 3 Months
Number of Participants Classified as a Responder (Based on Durable Wound Closure at Month 3)
Wound closure of the treatment site was defined as complete skin re-epithelialization and the absence of drainage. A participant whose StrataGraft treatment site achieves durable wound closure without autograft placement is classified as a responder.
Time frame: Month 3
Pain at the Designated Donor Sites by Day 14
Pain scores from the FACES scale range from 0 (no pain) to 5 (worst pain). Pain scores from Day 3, Day 7, and Day 14 (where available) are averaged for the summary statistics.
Time frame: Day 3, Day 7 and Day 14, average of the 3 days reported
Total Scar Assessment (POSAS) Score by Observer at Month 3
Total Score is the sum of the scores for vascularization, pigmentation, thickness, relief, pliability, and surface area. For each of the 6 assessment categories, the scale ranged from 1=normal skin to 10=worst scar imaginable, with the highest possible score of 10. A higher score indicates worse scarring, so the best possible total score for the 6 categories is 6, and the worst possible score is 60.
Time frame: at Month 3
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