- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04765202
StrataGraft Overlay of Meshed Autograft in Full-thickness Thermal Burns (StrataSOMA)
A Phase 1/2a, Controlled, Randomized, Multicenter Study Evaluating the Efficacy, Safety, and Tolerability of StrataGraft Overlay of Meshed Autograft (SOMA) in Treatment of Full-Thickness Thermal Burns
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 more widely meshed than AG Tx site 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20010
- MedStar Washington Hospital Center
-
-
Florida
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Tampa, Florida, United States, 33606
- Tampa General Hospital / University of South Florida
-
-
Iowa
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Iowa City, Iowa, United States, 52242
- University of Iowa Hospitals and Clinics
-
-
New York
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Stony Brook, New York, United States, 11794
- Stony Brook University
-
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Has 2% to 49% (inclusive) total body surface area (TBSA) thermal burn area, including areas of 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:
- the safety or well-being of the participant
- the study objectives
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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). |
The control treatment is meshed autograft applied to a FT burn area
Other Names:
The experimental treatment is more widely meshed autograft than the AG Tx site applied to a FT burn area and covered with SOMA
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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, and no later than Week 20.
|
At Month 2
|
Number of Participants 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.
|
At Month 12
|
Collaborators and Investigators
Investigators
- Study Director: Clinical Team Leader, Stratatech, a Mallinckrodt Company
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MNK01062117
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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