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

Part of paid clinical trials in Fort Sam Houston, Texas.

Sponsor
The Metis Foundation
Study ID
NCT06503406
Status
Recruiting
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Conditions

  • Burns
  • Surgical Wound
  • Trauma Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • SupraSDRM® — DEVICE
    SupraSDRM® Bidegradable Matrix Wound Dressing is a tri-polymber, Biodegrable dermal covering manufactured by PolyMedics Innovations, GmbH.
  • NovoSorb® BTM — DEVICE
    NovoSorb® BTM absorbable synthetic wound dressing, PolyNovo Biomaterials, K172140

Study Details

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.

Key Dates

First listed
Jul 16, 2024
Start date
Jan 8, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SupraSDRM®
    Once randomization is completed and the site is adequately debrided the assigned treatment dressing will be applied according to their respective instructions for use. Supplemental supportive dressings including negative pressure treatment may be used in conjunction with the study dressings.
  • Active Comparator: SOC Skin Substitute
    Once randomization is completed and the site is adequately debrided the assigned treatment dressing will be applied according to their respective instructions for use. Supplemental supportive dressings including negative pressure treatment may be used in conjunction with the study dressings.

Primary Outcome Measure

Number of days between the application of the dermal substitute to when the dermal substitute is deemed suitable for grafting by the treatment care team. [ Time Frame: up to 5 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The United States Army Institute of Surgical ResearchFort Sam HoustonTexas78234
Kristin Anselmo
[email protected]
210-539-9689
Alicia Williams (PRINCIPAL_INVESTIGATOR)

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By research site
The United States Army Institute of Surgical Research· Fort Sam Houston, TX

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