Autografting is a surgical procedure to transplant healthy skin (donor skin) from another part of the patient'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 will receive meshed autograft on one part of their burn (AG Tx). They will receive meshed autograft with a StrataGraft covering (SOMA Tx) on a different part of their burn. Each participant will be involved in the study up to about 14 months.
Full Title of Study: “A Phase 1/2a, Controlled, Randomized, Multicenter Study Evaluating the Efficacy, Safety, Tolerability of StrataGraft Overlay of Meshed Autograft (SOMA) in Treatment of Full-Thickness Thermal Burns”
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: October 2022
- Procedure: AG Tx
- The control treatment is meshed autograft applied to a FT burn area
- Biological: SOMA Tx
- The experimental treatment is meshed autograft applied to a FT burn area and covered with SOMA
Arms, Groups and Cohorts
- Experimental: All participants
- 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).
Clinical Trial Outcome Measures
- Number of treatment sites with complete wound closure without additional autografting at Month 2
- Time Frame: at Month 2
- Complete wound closure is defined as complete skin re-epithelialization without drainage confirmed at 2 visits at least 2 weeks apart.
- Number of subjects with durable wound closure of the study treatment sites without additional autografting at Month 12
- Time Frame: at Month 12
- Durable wound closure is defined as persistence of closure, maintained for at least 3 months after the initial observation of closure.
Participating in This Clinical Trial
- Has 10% 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 treatment of the burn 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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 75 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Stratatech, a Mallinckrodt Company
- Provider of Information About this Clinical Study
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