Assessment of Safety and Effectiveness of NovoSorb® BTM in Severe Burns
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|ClinicalTrials.gov Identifier: NCT04090424|
Recruitment Status : Recruiting
First Posted : September 16, 2019
Last Update Posted : September 8, 2022
|Condition or disease||Intervention/treatment||Phase|
|Burns||Device: NovoSorb BTM Procedure: Standard of Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||May 19, 2021|
|Estimated Primary Completion Date :||May 2023|
|Estimated Study Completion Date :||May 2025|
Experimental: NovoSorb BTM
Application of NovoSorb BTM to study lesions
Device: 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.
Active Comparator: Standard of Care
Application of the institution's standard to care to study lesions.
Procedure: 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.
- Proportion of study lesions in both groups with complete wound closure after skin grafting [ Time Frame: 4 weeks after skin grafting ]Assessment of clinical outcome by wound closure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04090424
|Contact: Kim Bradbury||+1(949) email@example.com|
|Study Director:||Marcus Wagstaff, MBBS, PhD||Royal Adelaide Hospital, Adelaide SA 5000. Australia|