A Prospective Study Using SupraSDRM® in Promoting Healing and Reducing the Time to Grafting of Full-thickness Wounds
NCT06503406 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2025-02-21
Summary
This is a prospective, randomized, controlled, multi-center clinical study comparing SupraSDRM® to standard of care wound dressing, BTM, in the treatment of full-thickness wounds deemed not immediately suitable for definitive grafting will be performed.
Conditions
- Surgical Wound
- Burns
- Trauma Injury
Interventions
- DEVICE
-
SupraSDRM®
SupraSDRM® Bidegradable Matrix Wound Dressing is a tri-polymber, Biodegrable dermal covering manufactured by PolyMedics Innovations, GmbH.
- DEVICE
-
NovoSorb® BTM
NovoSorb® BTM absorbable synthetic wound dressing, PolyNovo Biomaterials, K172140
Sponsors & Collaborators
-
The University of Texas Medical Branch, Galveston
collaborator OTHER -
United States Department of Defense
collaborator FED -
The United States Army Institute of Surgical Research
collaborator UNKNOWN -
The Metis Foundation
lead OTHER
Principal Investigators
-
Rodney Chan, MD · Metis Foundation
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-31
- Primary Completion
- 2025-10-31
- Completion
- 2026-10-31
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