Home › Surgical Wound › NCT06503406
A Prospective Study Using SupraSDRM® in Promoting Healing and Reducing the Time to Grafting of Full-thickness Wounds
Recruiting
Who can join
Ages 18 to 85 · All sexes
Full eligibility criteria
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 malignancy * Wound infection at the time of planned wound dressing application * Wound that is a part of an active treatment arm of an interventional study (within 90 days of Screening Visit) * Pregnancy/lactation * Subjects who are unable to follow the protocol or who are likely to be non-compliant * Subjects with uncontrolled diabetes (defined by Hgb A1C \>10) * Subjects who are receiving systemic steroids or immune suppressive treatment * Subject with a known allergy to polylactide, polycaprolactone, polyvinyl alcohol, trimethylene carbonate or resorbable suture materials. * Prisoners
About the study
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.
What is being tested
- SupraSDRM® (device)
- NovoSorb® BTM (device)
Sponsor: The Metis Foundation · Participants: 24 · Started: Jan 8, 2026
Contact the study team
- Victoria Diaz, RN · Phone: 2105691140
Official record on ClinicalTrials.gov — NCT06503406
Locations in the U.S.
| Texas | The United States Army Institute of Surgical Research, Fort Sam Houston |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.