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

Launched by AVITA MEDICAL · Dec 20, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at two types of temporary dressings—Allograft and PermeaDerm—to see how they affect the healing of surgical wounds before a skin graft is placed. The study aims to compare not only the costs of using each dressing but also how well they stick to the skin, how ready the wound is for the skin graft, and whether there are any complications during the healing process. If you or a loved one is hospitalized due to a surgical wound that needs additional coverage, you might be eligible to participate.

To join the study, participants should have a wound that does not cover more than 30% of their body and needs a temporary dressing after surgery. They should also be hospitalized within three days of their injury and be willing to follow the study's requirements for about eight weeks. Throughout the study, photos of the wound will be taken during check-ups to track healing progress. This is a great opportunity to contribute to medical research while receiving care for a serious wound.

Gender

ALL

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.
• • -