150
Participants
Start Date
September 21, 2021
Primary Completion Date
April 30, 2026
Study Completion Date
December 31, 2026
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.
New York Presbyterian Weill Cornell Medicine, New York
Lehigh Valley Hospital and Health Network, Allentown
Temple University Hospital, Philadelphia
MedStar Washington Hospital Center, Washington D.C.
Virginia Commonwealth University Medical Center, Richmond
Wake Forest Baptist Health, Winston-Salem
University of North Carolina at Chapel Hill, Chapel Hill
Emory University at Grady Memorial Hospital, Atlanta
Tampa General Hospital, Tampa
The Ohio State University/ Wexner Medical Center, Columbus
Akron Children's Hospital, Burn Center, Akron
University of Iowa Hospital and Clinics, Iowa City
UW Health University Hospital, Madison
Loyola University of Chicago, Maywood
University of Kansas Hospital, Kansas City
University Medical Center, New Orleans, New Orleans
University of Texas Southwestern Medical Center, Dallas
Valleywise Health, Phoenix
Southern California Regional Burn Center at LAC+USC, Los Angeles
University of California Davis Medical Center, Sacramento
Bridgeport Hospital, Bridgeport
Brigham and Women's Hospital, Boston
Massachusetts General Hospital, Boston
Bembde Hospital, Aurangabad
National Burns Centre, Mumbai
Ganga Medical Centre and Hospitals PVT Ltd, Coimbatore
Biomedical Advanced Research and Development Authority
FED
PolyNovo Biomaterials Pty Ltd.
INDUSTRY