StrataGraft Overlay of Meshed Autograft in Full-thickness Thermal Burns

Phase 1

Terminated

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Has 2% to 49% (inclusive) total body surface area (TBSA) thermal burn area, including areas of full thickness (FT) injury clinically indicated for surgical excision and autografting, appropriate for protocol-defined treatment areas
Meets protocol-specified criteria for qualification and contraception
Is willing and able to comply with all study procedures and requirements
Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures

Exclusion Criteria

Is a prisoner, pregnant, or had previous autografting to treatment sites
Is expected to survive less than 3 months
Is participating in another interventional trial, or did within 30 days before enrollment
Has anticipated treatment sites that are outside protocol-specified parameters
Has concurrent clinically significant inhalation injury, inadequate fluid resuscitation, or burns of chemical or electrical (non-thermal) etiology
Has other signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:
1. The safety or well-being of the participant
2. The study objectives

Arm && Interventions

Group	Intervention	Description
All participants	AG Tx	Each participant will receive both treatments. On each participant, similar wounds will be identified as treatment sites. Treatment sites will be randomized to receive either AG Tx (control) or SOMA Tx (experimental).
All participants	SOMA Tx	Each participant will receive both treatments. On each participant, similar wounds will be identified as treatment sites. Treatment sites will be randomized to receive either AG Tx (control) or SOMA Tx (experimental).
Cohort1 Group1: AG Tx Sites	AG Tx	Participants received autograft treatment (AG Tx) consisting of autograft alone (mesh ratio "m", per clinical judgment) at the treatment site on Day 1.
Cohort1 Group1: SOMA Tx Sites	SOMA Tx	Participants received StrataGraft overlay of meshed autograft (SOMA Tx) at the treatment site in which m+1:1 meshed autograft was overlaid with StrataGraft, and applied to wounds of 100 to 400 square centimeters (cm\^2) in area on Day 1.
Cohort1 Group 2: AG Tx Sites	AG Tx	Participants received AG Tx consisting of autograft alone (mesh ratio "m", per clinical judgment) at the treatment site on Day 1.
Cohort1 Group2: SOMA Tx Sites	SOMA Tx	Participants received SOMA Tx on the treatment site in which m+2:1 meshed autograft was overlaid with StrataGraft, and applied to wounds of 100 to 400 cm\^2 in area on Day 1.

Primary Outcome Measures

Name	Time	Method
Number of Treatment Sites With Complete Wound Closure Without Additional Autografting at Month 2	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.
Number of Participants With Durable Wound Closure of Study Treatment Sites Without Additional Autografting at Month 12	At Month 12	Durable wound closure is defined as persistence of closure, maintained for at least 3 months after the initial observation of closure.

Secondary Outcome Measures

Name	Time	Method

Locations (5): University of Iowa Hospitals and Clinics
🇺🇸
Iowa City, Iowa, United States
Stony Brook University
🇺🇸
Stony Brook, New York, United States
Medstar Washington Hospital Center
🇺🇸
Washington, District of Columbia, United States
Tampa General Hospital / University of South Florida
🇺🇸
Tampa, Florida, United States
Medical University of South Carolina
🇺🇸
Charleston, South Carolina, United States