StrataGraft® Skin Tissue in the Promotion of Autologous Skin Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements

Phase 3

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
StrataGraft Skin Tissue	StrataGraft Skin Tissue	-
StrataGraft Skin Tissue	Autograft	-

Primary Outcome Measures

Name	Time	Method
Percent Area of Treatment Sites Requiring Autografting by Month 3	3 Months	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).
Number of Participants Classified as a Responder (Based on Durable Wound Closure at Month 3)	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.

Secondary Outcome Measures

Name	Time	Method
Pain at the Designated Donor Sites by Day 14	Day 3, Day 7 and Day 14, average of the 3 days reported	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.
Total Scar Assessment (POSAS) Score by Observer at Month 3	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.

Locations (16): Regional Medical Center Firefighters Burn Center
🇺🇸
Memphis, Tennessee, United States
Universtiy of California - Irvine Health Regional Burn Center
🇺🇸
Orange, California, United States
University of South Alabama Medical Center
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Mobile, Alabama, United States
MedStar Washington Hospital Center
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Washington, District of Columbia, United States
Baton Rouge Medical Center
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Baton Rouge, Louisiana, United States
University of Missouri
🇺🇸
Columbia, Missouri, United States
University of Iowa
🇺🇸
Iowa City, Iowa, United States
U.S. Army Institute of Surgical Research Adult Burn Center
🇺🇸
Fort Sam Houston, Texas, United States
Arizona Burn Center at Maricopa Medical Center
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Phoenix, Arizona, United States
University of Pittsburgh Medical Center
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Pittsburgh, Pennsylvania, United States
Wake Forest University Baptist Medical Center
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Winston-Salem, North Carolina, United States
University of Wisconsin Hospital
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Madison, Wisconsin, United States
UC Davis
🇺🇸
Sacramento, California, United States
University of Florida Health Shands Burn Center
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Gainesville, Florida, United States
Tampa General Hospital - Regional Burn Center
🇺🇸
Tampa, Florida, United States
University Medical Center
🇺🇸
New Orleans, Louisiana, United States