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