Randomized Controlled Trial to Investigate Clinical Outcomes and Associated Costs When PermeaDerm is Used as Temporary Dressing for Surgical Wounds
NCT ID: NCT06750809
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2025-02-21
2026-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PermeaDerm Temporary Biosynthetic Wound Matrix
PermeaDerm Biosynthetic Wound Matrix
Study participants randomized (1:1) to this arm will receive PermeaDerm Biosynthetic Wound Matrix prior to skin graft.
Frozen Human Cadaveric Allograft (FHCA)
Frozen Human Cadaveric Allograft (FHCA)
Study participant randomized (1:1) to this arm will receive Frozen Human Cadaveric Allograft (FHCA) prior to skin graft.
Interventions
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PermeaDerm Biosynthetic Wound Matrix
Study participants randomized (1:1) to this arm will receive PermeaDerm Biosynthetic Wound Matrix prior to skin graft.
Frozen Human Cadaveric Allograft (FHCA)
Study participant randomized (1:1) to this arm will receive Frozen Human Cadaveric Allograft (FHCA) prior to skin graft.
Eligibility Criteria
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Inclusion Criteria
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
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.
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ALL
No
Sponsors
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Avita Medical
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Kylie Wentworth
Role: primary
Role: backup
Other Identifiers
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CTP012
Identifier Type: -
Identifier Source: org_study_id
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