💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
The United States Army Institute of Surgical Research
Fort Sam Houston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.