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

NCT06750809 | Active Not Recruiting FDA Device

• 1 other identifier: CTP012
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 13

Brief 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.

Conditions

Surgical Wound; Trauma Wound; Autografts; Partial-thickness Burn; Partial Thickness Wounds

Keywords

Skin graft, surgical wound, trauma wound

Outcome Measures

Primary Outcomes (1)

• Reduction of Cost per Total Body Surface Area (TBSA)

  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.

  8 weeks post treatment.

Study Arms (2)

PermeaDerm Temporary Biosynthetic Wound Matrix

EXPERIMENTAL

Device: PermeaDerm Biosynthetic Wound Matrix

Frozen Human Cadaveric Allograft (FHCA)

EXPERIMENTAL

Device: Frozen Human Cadaveric Allograft (FHCA)

Interventions

Frozen Human Cadaveric Allograft (FHCA) DEVICE

Study participant randomized (1:1) to this arm will receive Frozen Human Cadaveric Allograft (FHCA) prior to skin graft.

Frozen Human Cadaveric Allograft (FHCA)

PermeaDerm Biosynthetic Wound Matrix DEVICE

Study participants randomized (1:1) to this arm will receive PermeaDerm Biosynthetic Wound Matrix prior to skin graft.

PermeaDerm Temporary Biosynthetic Wound Matrix

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must meet all the following criteria to be eligible for participation:
• The patient's wound requires temporary dressing coverage after surgical excision and prior to autografting.
• The patient has a surgical wound up to 30% (inclusive) total body surface area (TBSA).
• 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.
• The patient is hospitalized within 3 days of injury.
• The surgical excision occurs within 5 days post-injury.
• The patient (or parent/guardian/legally authorized representative) is willing and able to comply with all study procedures and visit schedule.
• 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).
• In the opinion of the investigator, the patient (or parent/guardian/legally authorized representative) must be able to:
• Understand the full nature and purpose of the study, including possible risks and adverse events,
• Understand instructions, and
• Provide voluntary written informed consent.

You may not qualify if:

• Subjects who meet any of the following criteria are not eligible for participation:
• The study area has received prior surgical intervention.
• 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.
• Clinical signs of wound infection at study area that in the investigator's opinion may compromise patient safety or trial objectives.
• The patient has any of the following
• morbid obesity (BMI \>40),
• immunodeficiency,
• venous insufficiency/PVD of the lower extremities (when study area is also in this location),
• chronic malnourishment,
• inhalation injury (\>Grade 1 based on AIS grading scale),
• current abuser of alcohol and/or illicit drugs based upon medical history and/or lab results,
• diabetes mellitus with HbA1c \>9.0%, and/or
• advanced renal disease (eGFR \<59) or liver disease (LFTs \>2.5 times the upper limit).
• The patient has any another condition, that in the investigator's opinion may compromise patient safety or the trial objectives.
• The patient is unable to understand English or Spanish.

Sponsors & Collaborators

• Avita Medical: lead

Study Sites (13)

Valleywise Health

Phoenix, Arizona, 85008, United States

Location

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Grady Memorial

Atlanta, Georgia, 30303, United States

Location

Univ of Iowa

Iowa City, Iowa, 52242, United States

Location

University of Kansas

Kansas City, Kansas, 66160, United States

Location

Univ of Louisville Burn Center

Louisville, Kentucky, 40202, United States

Location

University Medical Center

New Orleans, Louisiana, 70112, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

Location

Akron Children's Hospital

Akron, Ohio, 44308, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Regional One Firefighter's Burn Center

Memphis, Tennessee, 38163, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 27, 2024
• Study Start: February 21, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)