Burns Clinical Trial
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
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).
Status | Recruiting |
Enrollment | 150 |
Est. completion date | December 2025 |
Est. primary completion date | March 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Sunnybrook Health Sciences Centre, Ross Tilley Burn Centre | Toronto | Ontario |
India | Bembde Hospital | Aurangabad | Maharashtra |
India | Ganga Medical Centre and Hospitals PVT Ltd | Coimbatore | Tamil Nadu |
India | National Burns Centre | Mumbai | Maharashtra |
United States | Akron Children's Hospital, Burn Center | Akron | Ohio |
United States | Lehigh Valley Hospital and Health Network | Allentown | Pennsylvania |
United States | Emory University at Grady Memorial Hospital | Atlanta | Georgia |
United States | University of Colorado Hospital, Burn Center and Frost Center | Aurora | Colorado |
United States | Baton Rouge General Medical Center | Baton Rouge | Louisiana |
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Bridgeport Hospital | Bridgeport | Connecticut |
United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
United States | Loyola University of Chicago | Chicago | Illinois |
United States | The Ohio State University/ Wexner Medical Center | Columbus | Ohio |
United States | University of Texas Southwestern Medical Center | Dallas | Texas |
United States | University of Iowa Hospital and Clinics | Iowa City | Iowa |
United States | University of Kansas Hospital | Kansas City | Kansas |
United States | University of Nevada, Las Vegas, School of Medicine | Las Vegas | Nevada |
United States | Southern California Regional Burn Center at LAC+USC | Los Angeles | California |
United States | UW Health University Hospital | Madison | Wisconsin |
United States | Loyola University of Chicago | Maywood | Illinois |
United States | University Medical Center, New Orleans | New Orleans | Louisiana |
United States | New York Presbyterian Weill Cornell Medicine | New York | New York |
United States | Temple University Hospital | Philadelphia | Pennsylvania |
United States | Valleywise Health | Phoenix | Arizona |
United States | Legacy Emanuel Medical Center, and the Oregon Burn Center | Portland | Oregon |
United States | Virginia Commonwealth University Medical Center | Richmond | Virginia |
United States | University of California Davis Medical Center | Sacramento | California |
United States | Tampa General Hospital | Tampa | Florida |
United States | MedStar Washington Hospital Center | Washington | District of Columbia |
United States | Wake Forest Baptist Health | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
PolyNovo Biomaterials Pty Ltd. | Biomedical Advanced Research and Development Authority |
United States, Canada, India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of study lesions in both groups with complete wound closure after skin grafting | Assessment of clinical outcome by wound closure | 4 weeks after skin grafting |
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