WithdrawnNot Applicable

Permeaderm Versus Homograft for Full-thickness Burns

Stopped: Protocol was withdrawn and closed by IRB in April, 2018 prior to enrollment of first patient

United States0Started 2018-01-31

Plain-language 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 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.

Who can participate

Age range6 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * ≥ 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 Criteria: * 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)

What they're measuring

Time to heal

Timeframe: up to 8 weeks after initial grafting

Trial details

NCT IDNCT04673435

SponsorThe University of Texas Medical Branch, Galveston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-07-31

View on ClinicalTrials.gov More Full Thickness Burn trials