SupraSDRM vs standard dressing for full-thickness wounds requiring grafting

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized, controlled, multicenter study enrolling adults with full-thickness wounds not yet ready for grafting. Participants are assigned to SupraSDRM® or NovoSorb® BTM as the wound dressing. The trial assesses time to graft readiness and healing outcomes over a defined wound area (5–125 cm2). Twenty-four patients will be enrolled across participating centers, following standard inclusion and exclusion criteria. The study aims to determine whether SupraSDRM® can promote faster healing and reduce the time to grafting compared with current standard care.

Why it matters

Who can join: the full rules

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

Where it's running

• The United States Army Institute of Surgical Research
  Fort Sam Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Rodney Chan, MD — Metis Foundation
• Study coordinator: Victoria Diaz, RN
• Email: Diaz@metisfoundationusa.org
• Phone: 2105691140

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.