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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Provide written informed consent directly or via legal representative prior to any clinical study procedures being performed
2. Willing to comply with all study procedures and expects to be available for the duration of the study
3. Male and females ≥ 18 years of age and ≤ 75 years of age
4. Patients with deep dermal or full thickness burns between 3% and 60%, inclusive, of their total body surface area (TBSA).
Types of burns include the following:
* Scalding including from hot water, cooking oil, grease
* Flame
* Flash
* Contact
5. Subjects who have staged surgical procedures planned e.g., one procedure to excise the burn injury and a later procedure to prepare the wound bed and apply an autologous skin graft.
6. The minimum total area across all lesions to have NovoSorb® BTM applied is 3% TBSA
7. Females, who are non-pregnant, naturally postmenopausal, or who agree to use effective contraceptive methods throughout the course of the study.
Exclusion Criteria:
1. Has a known hypersensitivity to polyurethane
2. Only a non-burn injury has been experienced by the subject including soft-tissue degloving and friction burn/crush, i.e., road rash
3. Multiple traumas, i.e., significant traumatic injury to a solid organ in addition to skin
4. Presence of a medical condition with a life expectancy of less than 12 months, such as advanced malignancy
5. Presence of a medical condition that might interfere with treatment evaluation; or require a change in therapy including but not limited to, significant immune deficiency, or skin or vascular diseases in the area of the wound
6. For females - has known or suspected pregnancy, planned pregnancy, or during lactation
7. Has exposure to any other investigational agent within the last 6 months
8. Has exposure to any other treatment/device that will interfere with NovoSorb® BTM integration
9. Anticipated inability to perform wound care and follow-up procedures
10. Anticipates of a level of non-compliance
11. The use of off-label treatments for full-thickness / deep-dermal burns is not permitted
12. Clinical signs of wound infection at areas to be potentially treated using NovoSorb® BTM that in the opinion of the investigator may compromise safety and study objectives
13. The use of NovoSorb® BTM on the face and in the perineum area is not permitted
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
Official registry record
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.
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