Assessment of Safety and Effectiveness of NovoSorb® BTM in Severe Burns
NCT ID: NCT04090424
Last Updated: 2025-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
150 participants
INTERVENTIONAL
2021-09-21
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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NovoSorb BTM
Application of NovoSorb BTM to study lesions
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
Application of the institution's standard of care to study lesions.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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Biomedical Advanced Research and Development Authority
FED
PolyNovo Biomaterials Pty Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Marcus Wagstaff, MBBS, PhD
Role: STUDY_DIRECTOR
Royal Adelaide Hospital, Adelaide SA 5000. Australia
Locations
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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
University Medical Center, New Orleans
New Orleans, Louisiana, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
New York Presbyterian Weill Cornell Medicine
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States
Akron Children's Hospital, Burn Center
Akron, Ohio, United States
The Ohio State University/ Wexner Medical Center
Columbus, Ohio, United States
Lehigh Valley Hospital and Health Network
Allentown, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States
UW Health University Hospital
Madison, Wisconsin, United States
Bembde Hospital
Aurangabad, Maharashtra, India
National Burns Centre
Mumbai, Maharashtra, India
Ganga Medical Centre and Hospitals PVT Ltd
Coimbatore, Tamil Nadu, India
Countries
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Related Links
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Sponsor website
Other Identifiers
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CP-003
Identifier Type: -
Identifier Source: org_study_id
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