RECRUITING

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

Conditions

Burn Pressure Ulcer of Skin Venous Ulcer Diabetic Ulcers Chronic Vascular Ulcer Surgical Wound Donor Site Complication Mohs Surgery Skin Tear Draining Wound Trauma Wound Autografts Partial Thickness Burn Partial Thickness Wounds Skin graft, surgical wounds, temporary dressing, burn, ulcers, moh's, donor site healing, donor site coverage, coverage of meshed autograft, pressure ulcer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-02

Study Completion:2026-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06750809

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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, 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 pregnant (a pregnancy test is to be performed in accordance with local institutional requirements). 7. The patient is unable to understand English or Spanish. 8. The patient has a known hypersensitivity to bovine-derived collagen materials, porcine, aloe vera materials, or contraindications to the frozen human cadaveric allograft. 9. The patient's life expectancy is less than 1 year.

Inclusion Criteria

Exclusion 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.

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,
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 pregnant (a pregnancy test is to be performed in accordance with local institutional requirements).
7. The patient is unable to understand English or Spanish.
8. The patient has a known hypersensitivity to bovine-derived collagen materials, porcine, aloe vera materials, or contraindications to the frozen human cadaveric allograft.
9. The patient's life expectancy is less than 1 year.

Contacts and Locations

Study Contact

Elizabeth Kirshner

CONTACT

833-462-8482

ekirshner@avitamedical.com

Study Locations (Sites)

Valleywise Health

Phoenix, Arizona, 85008

United States

Collaborators and Investigators

Sponsor: Avita Medical

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02

Study Completion Date2026-02

Study Record Updates

Study Start Date2025-02

Study Completion Date2026-02

Terms related to this study

Keywords Provided by Researchers

Skin graft, surgical wounds, temporary dressing, burn, ulcers, moh's, donor site healing, donor site coverage, coverage of meshed autograft, pressure ulcer

Additional Relevant MeSH Terms

Burn
Pressure Ulcer of Skin
Venous Ulcer
Diabetic Ulcers
Chronic Vascular Ulcer
Surgical Wound
Donor Site Complication
Mohs Surgery
Skin Tear
Draining Wound
Trauma Wound
Autografts
Partial Thickness Burn
Partial Thickness Wounds