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A Prospective Study Using SupraSDRM® in Promoting Healing and Reducing the Time to Grafting of Full-thickness Wounds

RecruitingNAAges 18 Years - 85 YearsAllThe Metis Foundation
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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
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What it tests

  • SupraSDRM®
  • NovoSorb® BTM
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Where

1 site
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.
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