Status:
COMPLETED
StrataGraft® Skin Tissue Expanded Access at Specific Study Sites ( StrataCAT )
Lead Sponsor:
Stratatech, a Mallinckrodt Company
Conditions:
Deep Partial-thickness Burn
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
An autograft is a piece of skin taken from a healthy area of the body to be used to treat severe burns on another part of the same body. StrataGraft skin tissue was an investigational tissue that cou...
Detailed Description
The primary purpose of this trial was to provide expanded access to StrataGraft for thermally induced DPT burns that contained intact dermal elements and for which surgical excision and autograft woul...
Eligibility Criteria
Inclusion
- To be considered for inclusion, a participant must:
- Provide written informed consent
- Have enough healthy skin to reserve as donor site(s), in case autografting becomes necessary
- Have protocol-defined thermal burn(s) on the torso, upper extremities and lower extremities:
- that are the right size for treatment areas,
- with intact dermal elements for which excision and autografting are clinically indicated, and
- have not been previously excised and grafted.
Exclusion
- A participant must be excluded from participation if he/she:
- Is pregnant, a prisoner, or expected to live less than 3 months
- Has any other condition that, per protocol or in the opinion of the investigator, may compromise the participant's safety or the study objectives
- Has participated in an investigational study within 90 days before enrollment
Key Trial Info
Start Date :
February 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 26 2022
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04123548
Start Date
February 18 2020
End Date
January 26 2022
Last Update
November 9 2023
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California Irvine
Orange, California, United States, 92868-3298
2
MedStar Health Research Institute
Washington D.C., District of Columbia, United States, 20010
3
University of Florida (Health Shands Burn Center)
Gainesville, Florida, United States, 32610
4
University of Iowa
Iowa City, Iowa, United States, 52242