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NCT06503406NARecruiting

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

The Metis Foundation

Start Date

1/8/2026

Completion Date

12/1/2027

Summary

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.

Detailed Description

Twenty-four patients with full-thickness wounds fulfilling inclusion criteria of the study will be consented and enrolled into the clinical trial. An area (≥ 5 and ≤125 cm2) deemed not immediately ready to accept skin graft will be designated as the study site. The study site will be randomized to receive either SupraSDRM® or the SoC wound dressing, NovoSorb® BTM.

Eligibility Criteria

Age Range: 18 years to 85 years

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

Interventions

DEVICE

SupraSDRM®

DEVICE

NovoSorb® BTM

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Conditions

Surgical WoundBurnsTrauma Injury

Locations

The United States Army Institute of Surgical Research

Fort Sam Houston, Texas 78234

United States