New dressing may cut costs for skin graft patients
NCT ID NCT06750809
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares a new temporary dressing called PermeaDerm with a standard one (Allograft) for people who need a skin graft after surgery or injury. About 40 participants will have the dressing applied to their wound, then a skin graft a few days later. Researchers will check costs, how well the dressing sticks, wound healing, and complications over about 8 weeks.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Feb 2025
- Expected to finish
-
May 2026
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Subjects must meet all the following criteria to be eligible for participation: 1. The patient's wound requires temporary dressing coverage after surgical excision and prior to autografting. 2. The patient has a surgical wound up to 30% (inclusive) total body surface area (TBSA). 3. 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. 4. The patient is hospitalized within 3 days of injury. 5. The surgical excision occurs within 5 days post-injury. 6. The patient (or parent/guardian/legally authorized representative) is willing and able to comply with all study procedures and visit schedule. 7. 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). 8. In the opinion of the investigator, the patient (or parent/guardian/legally authorized representative) must be able to: 1. Understand the full nature and purpose of the study, including possible risks and adverse events, 2. Understand instructions, and 3. Provide voluntary written informed consent. Exclusion Criteria: Subjects who meet any of the following criteria are not eligible for participation: 1. The study area has received prior surgical intervention. 2. 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. 3. Clinical signs of wound infection at study area that in the investigator's opinion may compromise patient safety or trial objectives. 4. The patient has any of the following 1. morbid obesity (BMI \>40), 2. immunodeficiency, 3. venous insufficiency/PVD of the lower extremities (when study area is also in this location), 4. chronic malnourishment, 5. inhalation injury (\>Grade 1 based on AIS grading scale), 6. current abuser of alcohol and/or illicit drugs based upon medical history and/or lab results, 7. diabetes mellitus with HbA1c \>9.0%, and/or 8. advanced renal disease (eGFR \<59) or liver disease (LFTs \>2.5 times the upper limit). 5. The patient has any another condition, that in the investigator's opinion may compromise patient safety or the trial objectives. 6. The patient is unable to understand English or Spanish. 7. The patient has a known hypersensitivity to bovine-derived collagen materials, porcine, aloe vera materials, or contraindications to the frozen human cadaveric allograft. 8. The patient's life expectancy is less than 1 year. \-
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Autografts are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Akron Children's Hospital
Akron, Ohio, 44308, United States
-
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157, United States
-
Grady Memorial
Atlanta, Georgia, 30303, United States
-
Medstar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
-
Ohio State University
Columbus, Ohio, 43210, United States
-
Regional One Firefighter's Burn Center
Memphis, Tennessee, 38163, United States
-
Univ of Iowa
Iowa City, Iowa, 52242, United States
-
Univ of Louisville Burn Center
Louisville, Kentucky, 40202, United States
-
University Medical Center
New Orleans, Louisiana, 70112, United States
-
University of Kansas
Kansas City, Kansas, 66160, United States
-
University of Rochester
Rochester, New York, 14642, United States
-
Valleywise Health
Phoenix, Arizona, 85008, United States
-
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a simple ointment make surgical scars heal better?
- Can a dissolvable dressing get burn patients to skin grafts faster?
- Can glue and barbed sutures beat staples for joint surgery wounds?
- New Bandage-Like matrix could speed healing after skin cancer removal
- Eye drop gel shows promise for skin graft healing, but trial stalls
- 3D scanning could make facial fat grafting more predictable