Permeaderm Versus Homograft for Full-thickness Burns

Withdrawn before enrolling · Not applicable

Conditions studied: Full Thickness Burn

In brief

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 storage spaces in comparison to other products. The purpose of this study is to determine the extent to which PermeaDerm® dressing promotes wound bed maturation when used as a temporary dressing for excised full-thickness burn wounds. Efficacy and safety in promoting wound bed maturation for successive autografting will be determined through direct comparison to FHCA.

Key facts

Study ID

NCT04673435

Run by

The University of Texas Medical Branch, Galveston

People needed

0

Starts

2018-01-31

Expected to finish

2020-07-31

Last updated by the study team

2020-12-17

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 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.

You may not qualify if…

• 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)

Where it is running

• University of texas Medical Branch Galveston — Galveston, Texas, United States

Full record on ClinicalTrials.gov

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