Status:
TERMINATED
StrataGraft Overlay of Meshed Autograft in Full-thickness Thermal Burns
Lead Sponsor:
Stratatech, a Mallinckrodt Company
Conditions:
Full Thickness Thermal Burn
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
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 fu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 7 2024
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04765202
Start Date
October 10 2021
End Date
June 7 2024
Last Update
May 16 2025
Active Locations (5)
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1
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
2
Tampa General Hospital / University of South Florida
Tampa, Florida, United States, 33606
3
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
4
Stony Brook University
Stony Brook, New York, United States, 11794