About this trial
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.
Eligibility criteria
Qualifiers
Patient age ≥18 years and ≤85 years
Full-thickness traumatic injury, surgical wound, or excised full-thickness burn (e.g., friction, contact, flame, scalding etiology), where immediate grafting is not deemed suitable by the treating surgeon
Wound size ≥ 5cm2 not immediately suitable for graft application
Subject or legally authorized representative is able and willing to sign informed consent
Disqualifiers
Study wound may not include areas of the face, and neck and genitalia.
Wound with metal hardware exposure
Pressure sores
Wounds with residual malignancy
Trial design
Treatments tested in this trial
- SupraSDRM®
- NovoSorb® BTM
Treatment groups
Locations
Sponsors and collaborators
The Metis Foundation
Lead sponsor
The University of Texas Medical Branch, Galveston
Collaborator
United States Department of Defense
Collaborator
The United States Army Institute of Surgical Research
Collaborator