Comparing two temporary dressings for surgical wounds

A Prospective Post-Market Multicenter Randomized Controlled Clinical Study to Investigate Clinical Outcomes and Associated Costs When PermeaDerm is Used as Temporary Dressing for the Management of Surgical Wounds

This study is testing which of two temporary dressings for surgical wounds works better and costs less for patients who need skin grafts after surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sex: All
• Sponsor: Avita Medical (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 9 sites (Phoenix, Arizona and 8 other locations)
• Trial ID: NCT06750809 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the clinical outcomes and costs associated with two types of temporary dressings, PermeaDerm and frozen human cadaveric allograft (FHCA), used for surgical wounds requiring skin grafts. Patients hospitalized within three days of injury will be randomly assigned to receive one of the dressings after surgical excision of their wound. The study will assess factors such as adherence, wound bed preparation, time to autografting, graft take, and any safety-related adverse events. Participants will be monitored through regular evaluations and follow-ups for up to eight weeks post-treatment.

Who should consider this trial

Good fit: Ideal candidates are patients with surgical wounds up to 30% total body surface area who are hospitalized within three days of injury.

Not a fit: Patients with wounds that do not require temporary dressing coverage or those who are not hospitalized within the specified timeframe may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved healing outcomes and cost-effectiveness for patients requiring skin grafts.

How similar studies have performed: Other studies have shown promising results with similar approaches, but this specific comparison of dressings is novel.

Eligibility criteria

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.

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Where this trial is running

Phoenix, Arizona and 8 other locations

• Valleywise Health — Phoenix, Arizona, United States (Recruiting)
• Grady Memorial — Atlanta, Georgia, United States (Not_yet_recruiting)
• University of Kansas — Kansas City, Kansas, United States (Recruiting)
• University Medical Center — New Orleans, Louisiana, United States (Not_yet_recruiting)
• University of Rochester — Rochester, New York, United States (Not_yet_recruiting)
• Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina, United States (Recruiting)
• Akron Children's Hospital — Akron, Ohio, United States (Not_yet_recruiting)
• Ohio State University — Columbus, Ohio, United States (Recruiting)
• Regional One Firefighter's Burn Center — Memphis, Tennessee, United States (Not_yet_recruiting)

Study contacts

• Study coordinator: Elizabeth Kirshner

Conditions Surgical Wound; Trauma Wound; Autografts; Partial-thickness Burn; Partial Thickness Wounds; Skin graft, surgical wound, trauma wound