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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

Sponsor: The Metis Foundation · Participants: 24 · Started: Jan 8, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT06503406

Locations in the U.S.

TexasThe 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.