Randomized Controlled Trial to Investigate Clinical Outcomes and Associated Costs When PermeaDerm is Used as Temporary Dressing for Surgical Wounds

Running, not enrolling · Not applicable

Conditions studied: Surgical Wound, Trauma Wound, Autografts, Partial-thickness Burn, Partial Thickness Wounds

In brief

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.

Key facts

Study ID

NCT06750809

Run by

Avita Medical

People needed

40

Starts

2025-02-21

Expected to finish

2026-05-01

Last updated by the study team

2026-03-11

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must meet all the following criteria to be eligible for participation:
• 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:
• Understand the full nature and purpose of the study, including possible risks and adverse events,
• Understand instructions, and
• Provide voluntary written informed consent.

You may not qualify if…

• Subjects who meet any of the following criteria are not eligible for participation:
• 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),
• chronic malnourishment,
• inhalation injury (>Grade 1 based on AIS grading scale),
• current abuser of alcohol and/or illicit drugs based upon medical history and/or lab results,
• diabetes mellitus with HbA1c >9.0%, and/or
• advanced renal disease (eGFR <59) or liver disease (LFTs >2.5 times the upper limit).
• The patient has any another condition, that in the investigator's opinion may compromise patient safety or the trial objectives.
• The patient is unable to understand English or Spanish.
• The patient has a known hypersensitivity to bovine-derived collagen materials, porcine, aloe vera materials, or contraindications to the frozen human cadaveric allograft.
• The patient's life expectancy is less than 1 year.

Where it is running

• Valleywise Health — Phoenix, Arizona, United States
• Medstar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Grady Memorial — Atlanta, Georgia, United States
• Univ of Iowa — Iowa City, Iowa, United States
• University of Kansas — Kansas City, Kansas, United States
• Univ of Louisville Burn Center — Louisville, Kentucky, United States
• University Medical Center — New Orleans, Louisiana, United States
• University of Rochester — Rochester, New York, United States
• Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina, United States
• Akron Children's Hospital — Akron, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• Regional One Firefighter's Burn Center — Memphis, Tennessee, United States
• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.