Assessment of Safety and Effectiveness of NovoSorb® BTM in Severe Burns
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 50
Summary
- Conditions
- Burns
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 21 years and 70 years
- Gender
- Both males and females
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 between burn wounds treated with BTM and the institution's standard of care (SOC).
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 between burn wounds treated with BTM and the institution's standard of care (SOC).
Tracking Information
- NCT #
- NCT04090424
- Collaborators
- Biomedical Advanced Research and Development Authority
- Investigators
- Study Director: Marcus Wagstaff, MBBS, PhD Royal Adelaide Hospital, Adelaide SA 5000. Australia
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