Permeaderm Versus Homograft for Full-thickness Burns (NCT04673435) | Clinical Trial Compass
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Stopped: Protocol was withdrawn and closed by IRB in April, 2018 prior to enrollment of first patient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 range
6 Months
Sex
ALL
See this in plain English?
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to heal
Timeframe: up to 8 weeks after initial grafting
Trial details
NCT IDNCT04673435
SponsorThe University of Texas Medical Branch, Galveston