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

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.

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.

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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