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
SexALL
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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).
✓. In the opinion of the investigator, the patient (or parent/guardian/legally authorized representative) must be able to:
Exclusion criteria
✕
What they're measuring
1
Reduction of Cost per Total Body Surface Area (TBSA)
. 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),