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).
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). A comparison will be made between burn wounds treated with BTM and the institution's standard of care (SOC).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
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.
Burn wounds will be treated using the institution's standard of care, e.g. primary skin grafting, cadaveric allograft followed by skin grafting.
Proportion of study lesions in both groups with complete wound closure after skin grafting
Assessment of clinical outcome by wound closure
Time frame: 4 weeks after skin grafting
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 16 more locations