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ACTIVE NOT RECRUITING
NCT06750809
NA

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

Sponsor: Avita Medical

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-02-21

Completion Date

2026-05

Last Updated

2026-03-11

Healthy Volunteers

No

Interventions

DEVICE

PermeaDerm Biosynthetic Wound Matrix

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

DEVICE

Frozen Human Cadaveric Allograft (FHCA)

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

Locations (13)

Valleywise Health

Phoenix, Arizona, United States

Medstar Washington Hospital Center

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

Grady Memorial

Atlanta, Georgia, United States

Univ of Iowa

Iowa City, Iowa, United States

University of Kansas

Kansas City, Kansas, United States

Univ of Louisville Burn Center

Louisville, Kentucky, United States

University Medical Center

New Orleans, Louisiana, United States

University of Rochester

Rochester, New York, United States

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States

Akron Children's Hospital

Akron, Ohio, United States

Ohio State University

Columbus, Ohio, United States

Regional One Firefighter's Burn Center

Memphis, Tennessee, United States

Virginia Commonwealth University

Richmond, Virginia, United States