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

Last updated: April 18, 2025
Sponsor: Avita Medical
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stasis Dermatitis

Ulcers

Diabetic Foot Ulcers

Treatment

PermeaDerm Biosynthetic Wound Matrix

Frozen Human Cadaveric Allograft (FHCA)

Clinical Study ID

NCT06750809
CTP012
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 andprior 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-studytreatment area) that require temporary dressing, these areas must also be dressedaccording 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 andable to comply with all study procedures and visit schedule.

  7. The patient (or parent/guardian/legally authorized representative) agrees to abstainfrom any other treatment of the study area or enrollment in another interventionalclinical trial for the duration of his/her participation in the study (8 weekspost-autografting).

  8. In the opinion of the investigator, the patient (or parent/guardian/legallyauthorized representative) must be able to:

  9. Understand the full nature and purpose of the study, including possible risksand adverse events,

  10. Understand instructions, and

  11. Provide voluntary written informed consent.

Exclusion

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 systemiccorticosteroids, chemotherapy, or immunosuppressants, that in the investigator'sopinion may compromise patient safety or trial objectives.

  3. Clinical signs of wound infection at study area that in the investigator's opinionmay compromise patient safety or trial objectives.

  4. The patient has any of the following

  5. morbid obesity (BMI >40),

  6. immunodeficiency,

  7. venous insufficiency/PVD of the lower extremities (when study area is also inthis location),

  8. chronic malnourishment,

  9. inhalation injury (>Grade 1 based on AIS grading scale),

  10. current abuser of alcohol and/or illicit drugs based upon medical historyand/or lab results,

  11. diabetes mellitus with HbA1c >9.0%, and/or

  12. advanced renal disease (eGFR <59) or liver disease (LFTs >2.5 times the upperlimit).

  13. The patient has any another condition, that in the investigator's opinion maycompromise patient safety or the trial objectives.

  14. The patient is unable to understand English or Spanish.

  15. The patient has a known hypersensitivity to bovine-derived collagen materials,porcine, aloe vera materials, or contraindications to the frozen human cadavericallograft.

  16. The patient's life expectancy is less than 1 year.

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: PermeaDerm Biosynthetic Wound Matrix
Phase:
Study Start date:
February 21, 2025
Estimated Completion Date:
February 28, 2026

Study Description

This is a prospective two-arm randomized multicenter controlled study to evaluate the clinical outcomes and economic impact of PermeaDerm and frozen human cadaveric allograft (FHCA) when they are used as a temporary dressing on surgical wounds where autografting is clinically indicated.

Patients hospitalized within 3 days of injury with a surgical wound up to 30% (inclusive) total body surface area (TBSA) will be considered for participation in this study.

Patients will undergo surgical excision within five days post-injury and will be randomly assigned (1:1) to receive PermeaDerm or FHCA as a temporary dressing. One contiguous area will be selected by the investigator as the study treatment area. Any other areas that require a temporary dressing must be dressed per the randomization.

In addition to economic impact, the two temporary dressings will be compared with respect to adherence, wound bed preparation, time to autografting, graft take, and safety-related adverse events.

Following placement of the temporary dressing, investigators will evaluate the wound every 2-3 days. The temporary dressing may be replaced, per the randomization, as clinically indicated. When the study area is ready for autografting, the temporary dressing will be removed, and the study area will be autografted per the investigative site's standard of care. The donor area(s) may be dressed in PermeaDerm or the investigative site's standard of care.

Post-autografting, subjects will be followed for 8 weeks. Treatment-related and serious adverse events will be reported through the duration of the study. At all visits, subjects' study treatment areas and donor sites that are dressed in PermeaDerm will be documented using digital photography.

Connect with a study center

  • Valleywise Health

    Phoenix, Arizona 85008
    United States

    Active - Recruiting

  • Grady Memorial

    Atlanta, Georgia 30303
    United States

    Site Not Available

  • University of Kansas

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • University Medical Center

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • University of Rochester

    Rochester, New York 14642
    United States

    Site Not Available

  • Atrium Health Wake Forest Baptist

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

  • Akron Children's Hospital

    Akron, Ohio 44308
    United States

    Site Not Available

  • Ohio State University

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Regional One Firefighter's Burn Center

    Memphis, Tennessee 38163
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.