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Assessment of Safety and Effectiveness of NovoSorb® BTM in Severe Burns
Sponsor: PolyNovo Biomaterials Pty Ltd.
Summary
This is a multi-center, pivotal study to assess the safety and effectiveness of a new method of treating severe burns using NovoSorb® Biodegradable Temporizing Matrix (BTM).
Official title: A Pivotal Study to Assess the Safety and Effectiveness of NovoSorb® Biodegradable Temporizing Matrix (BTM) in the Treatment of Severe Burn Skin Injuries
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2021-09-21
Completion Date
2026-12
Last Updated
2026-02-24
Healthy Volunteers
No
Conditions
Interventions
NovoSorb BTM
NovoSorb BTM comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a nonbiodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied.
Standard of Care
Burn wounds will be treated using the institution's standard of care, e.g. primary skin grafting, cadaveric allograft followed by skin grafting.
Locations (26)
Valleywise Health
Phoenix, Arizona, United States
Southern California Regional Burn Center at LAC+USC
Los Angeles, California, United States
University of California Davis Medical Center
Sacramento, California, United States
Bridgeport Hospital
Bridgeport, Connecticut, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Tampa General Hospital
Tampa, Florida, United States
Emory University at Grady Memorial Hospital
Atlanta, Georgia, United States
Loyola University of Chicago
Maywood, Illinois, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States
University of Kansas Hospital
Kansas City, Kansas, United States
University Medical Center, New Orleans
New Orleans, Louisiana, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
New York Presbyterian Weill Cornell Medicine
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
Akron Children's Hospital, Burn Center
Akron, Ohio, United States
The Ohio State University/ Wexner Medical Center
Columbus, Ohio, United States
Lehigh Valley Hospital and Health Network
Allentown, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States
UW Health University Hospital
Madison, Wisconsin, United States
Bembde Hospital
Aurangabad, Maharashtra, India
National Burns Centre
Mumbai, Maharashtra, India
Ganga Medical Centre and Hospitals PVT Ltd
Coimbatore, Tamil Nadu, India