A Prospective Study Using SupraSDRM® in Promoting Healing and Reducing the Time to Grafting of Full-thickness Wounds
The Metis Foundation
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.
Description
Twenty-four patients with full-thickness wounds fulfilling inclusion criteria of the study will be consented and enrolled into the clinical trial. An area (≥ 5 and ≤125 cm2) deemed not immediately ready to accept skin graft will be designated as the study site. The study site will be randomized to receive either SupraSDRM® or the SoC wound dressing, NovoSorb® BTM.
Eligibility
- Age range
- 18–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 Exclusion Criteria: * Study wound may not include areas of the face, and neck and genitalia. * Wound with metal hardware exposure * Pressure sores * Wounds with residual mal…
Interventions
- DeviceSupraSDRM®
SupraSDRM® Bidegradable Matrix Wound Dressing is a tri-polymber, Biodegrable dermal covering manufactured by PolyMedics Innovations, GmbH.
- DeviceNovoSorb® BTM
NovoSorb® BTM absorbable synthetic wound dressing, PolyNovo Biomaterials, K172140
Location
- The United States Army Institute of Surgical ResearchFort Sam Houston, Texas