Status:
WITHDRAWN
Permeaderm Versus Homograft for Full-thickness Burns
Lead Sponsor:
The University of Texas Medical Branch, Galveston
Collaborating Sponsors:
Shriners Hospitals for Children
Conditions:
Full Thickness Burn
Eligibility:
All Genders
6+ years
Phase:
NA
Brief Summary
Frozen Human Cadaver Allograft (FHCA) is, nowadays, the gold standard for temporary coverage of excised full-thickness burns, but is also very expensive and requires additional personnel and major sto...
Detailed Description
In this prospective, randomized, matched design pilot study, we aim to compare the current standard of care FHCA to PermeaDerm®. 30 patients for each study arm (n total = 60) meeting the inclusion cr...
Eligibility Criteria
Inclusion
- ≥ 2 % total body surface area (TBSA) full thickness burned.
- Patients with two adjacent or body symmetrical full thickness burned areas (each ≥ 1 TBSA) and comparable in size (TBSA ± 0.5), that require debridement and autografting.
Exclusion
- Time from injury to admission \>= 5 days
- Sepsis on admission or clinically suspected infection (as per attending physician)
- Pregnancy or childbearing
- Positive HIV or hepatitis screens
- History of active malignancy
- Patients who do not require surgical debridement and autografting
- Patient with burn injuries originating from other causes (chemical, and frostbite)
Key Trial Info
Start Date :
January 31 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04673435
Start Date
January 31 2018
End Date
July 31 2020
Last Update
December 17 2020
Active Locations (1)
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1
University of texas Medical Branch Galveston
Galveston, Texas, United States, 77555