Status:
ACTIVE_NOT_RECRUITING
Assessment of Safety and Effectiveness of NovoSorb® BTM in Severe Burns
Lead Sponsor:
PolyNovo Biomaterials Pty Ltd.
Collaborating Sponsors:
Biomedical Advanced Research and Development Authority
Conditions:
Burns
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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).
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Provide written informed consent directly or via legal representative prior to any clinical study procedures being performed
- Willing to comply with all study procedures and expects to be available for the duration of the study
- Male and females ≥ 18 years of age and ≤ 75 years of age
- 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
- 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.
- The minimum total area across all lesions to have NovoSorb® BTM applied is 3% TBSA
- Females, who are non-pregnant, naturally postmenopausal, or who agree to use effective contraceptive methods throughout the course of the study.
Exclusion
- Has a known hypersensitivity to polyurethane
- Only a non-burn injury has been experienced by the subject including soft-tissue degloving and friction burn/crush, i.e., road rash
- Multiple traumas, i.e., significant traumatic injury to a solid organ in addition to skin
- Presence of a medical condition with a life expectancy of less than 12 months, such as advanced malignancy
- 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
- For females - has known or suspected pregnancy, planned pregnancy, or during lactation
- Has exposure to any other investigational agent within the last 6 months
- Has exposure to any other treatment/device that will interfere with NovoSorb® BTM integration
- Anticipated inability to perform wound care and follow-up procedures
- Anticipates of a level of non-compliance
- The use of off-label treatments for full-thickness / deep-dermal burns is not permitted
- 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
- The use of NovoSorb® BTM on the face and in the perineum area is not permitted
Key Trial Info
Start Date :
September 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04090424
Start Date
September 21 2021
End Date
December 1 2026
Last Update
June 3 2025
Active Locations (26)
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1
Valleywise Health
Phoenix, Arizona, United States, 85008
2
Southern California Regional Burn Center at LAC+USC
Los Angeles, California, United States, 90033
3
University of California Davis Medical Center
Sacramento, California, United States, 95817
4
Bridgeport Hospital
Bridgeport, Connecticut, United States, 06610