PermeaDerm Biosynthetic Wound MatrixFrozen Human Cadaveric Allograft (FHCA)
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.
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
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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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Primary outcome measure(s)
Reduction of Cost per Total Body Surface Area (TBSA) — 8 weeks post treatment. The reduction of cost per TBSA when PermeaDerm is used as a temporary dressing. The reduction in cost is hypothesized to be superior for PermeaDerm as compared to FHCA.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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