Recruiting

SupraSDRM® vs. BTM

Sponsor:

The Metis Foundation

Code:

NCT06503406

Conditions

Surgical Wound

Burns

Trauma Injury

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

SupraSDRM®

NovoSorb® BTM

Study Details

Brief 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.

Conditions

Surgical Wound

Burns

Trauma Injury

Study ID

NCT06503406

Start date

Jan 8, 2026

Status verified date

Aug, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

SupraSDRM®

SupraSDRM® Bidegradable Matrix Wound Dressing is a tri-polymber, Biodegrable dermal covering manufactured by PolyMedics Innovations, GmbH.

NovoSorb® BTM

NovoSorb® BTM absorbable synthetic wound dressing, PolyNovo Biomaterials, K172140

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 and Locations

Central contacts

Victoria Diaz, RN

2105691140Diaz@metisfoundationusa.org

Locations

The United States Army Institute of Surgical Research

Recruiting

Fort Sam Houston, Texas, United States, 78234

Contacts

Kristin Anselmo

210-539-9689kristin.k.anselmo.ctr@health.mil

Principal Investigator:

Alicia Williams

More Information

Sponsor

The Metis Foundation

Last update posted

Aug 13, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Metis Foundation on 2026-08-13.