Randomized Controlled Trial to Investigate Clinical Outcomes and Associated Costs When PermeaDerm… (NCT06750809) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Randomized Controlled Trial to Investigate Clinical Outcomes and Associated Costs When PermeaDerm is Used as Temporary Dressing for Surgical Wounds
United States40 participantsStarted 2025-02-21
Plain-language summary
The goal of this study is to compare the cost and clinical outcomes for two temporary dressings (Allograft and PermeaDerm) used in patients that need a skin graft to heal their wound. The researchers will review cost and other treatment results including how well both temporary dressings attach to the skin, how prepared the wound bed is to receive a skin graft, how long it takes for the skin to be ready to receive a skin graft, how well the skin graft takes and any complications. Patients will first have the temporary dressing applied to their wound, then a few days later, a skin graft will be performed. Patients will have photos of their wounds taken throughout the study including at all the clinic check-ups with the last check-up occurring about 8 weeks after treatment.
Who can participate
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
. The patient's wound requires temporary dressing coverage after surgical excision and prior to autografting.
. The patient has a surgical wound up to 30% (inclusive) total body surface area (TBSA).
. The study area is a contiguous area. If the patient has other areas (non-study treatment area) that require temporary dressing, these areas must also be dressed according to the randomization.
. The patient is hospitalized within 3 days of injury.
. The surgical excision occurs within 5 days post-injury.
. The patient (or parent/guardian/legally authorized representative) is willing and able to comply with all study procedures and visit schedule.
. The patient (or parent/guardian/legally authorized representative) agrees to abstain from any other treatment of the study area or enrollment in another interventional clinical trial for the duration of his/her participation in the study (8 weeks post-autografting).
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
Reduction of Cost per Total Body Surface Area (TBSA)
. In the opinion of the investigator, the patient (or parent/guardian/legally authorized representative) must be able to:
Exclusion criteria
. The study area has received prior surgical intervention.
. The patient is currently using medications or treatments such as systemic corticosteroids, chemotherapy, or immunosuppressants, that in the investigator's opinion may compromise patient safety or trial objectives.
. Clinical signs of wound infection at study area that in the investigator's opinion may compromise patient safety or trial objectives.
. The patient has any of the following
. morbid obesity (BMI \>40),
. immunodeficiency,
. venous insufficiency/PVD of the lower extremities (when study area is also in this location),