Assessment of Safety and Effectiveness of NovoSorb® BTM in Severe Burns
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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).
Eligibility
Primary outcome measure(s)
- Proportion of study lesions in both groups with complete wound closure after skin grafting — 4 weeks after skin grafting
Assessment of clinical outcome by wound closure
Trial sites (26)
| Facility | City | Region | Status |
|---|---|---|---|
| Valleywise Health | Phoenix | Arizona | |
| Southern California Regional Burn Center at LAC+USC | Los Angeles | California | |
| University of California Davis Medical Center | Sacramento | California | |
| Bridgeport Hospital | Bridgeport | Connecticut | |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | |
| Tampa General Hospital | Tampa | Florida | |
| Emory University at Grady Memorial Hospital | Atlanta | Georgia | |
| Loyola University of Chicago | Maywood | Illinois | |
| University of Iowa Hospital and Clinics | Iowa City | Iowa | |
| University of Kansas Hospital | Kansas City | Kansas | |
| University Medical Center, New Orleans | New Orleans | Louisiana | |
| Brigham and Women's Hospital | Boston | Massachusetts | |
| Massachusetts General Hospital | Boston | Massachusetts | |
| New York Presbyterian Weill Cornell Medicine | New York | New York | |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | |
| Akron Children's Hospital, Burn Center | Akron | Ohio | |
| The Ohio State University/ Wexner Medical Center | Columbus | Ohio | |
| Lehigh Valley Hospital and Health Network | Allentown | Pennsylvania | |
| Temple University Hospital | Philadelphia | Pennsylvania | |
| University of Texas Southwestern Medical Center | Dallas | Texas | |
| Virginia Commonwealth University Medical Center | Richmond | Virginia | |
| UW Health University Hospital | Madison | Wisconsin | |
| Bembde Hospital | Aurangabad | Maharashtra | |
| National Burns Centre | Mumbai | Maharashtra | |
| Ganga Medical Centre and Hospitals PVT Ltd | Coimbatore | Tamil Nadu |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04090424 on ClinicalTrials.gov ↗ ← All trials in the USA