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

NCT ID: NCT06503406

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2026-10-31

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.

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.

Conditions

Surgical Wound; Burns; Trauma Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

SupraSDRM®

Intervention Type: DEVICE

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

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.

Group Type: ACTIVE_COMPARATOR

NovoSorb® BTM

Intervention Type: DEVICE

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

Interventions

SupraSDRM®

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

Intervention Type: DEVICE

NovoSorb® BTM

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role: collaborator

United States Department of Defense

FED

Sponsor Role: collaborator

The United States Army Institute of Surgical Research

UNKNOWN

Sponsor Role: collaborator

The Metis Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rodney Chan, MD

Role: PRINCIPAL_INVESTIGATOR

Metis Foundation

Central Contacts

Victoria Diaz, RN

Role: CONTACT

Diaz@metisfoundationusa.org

2105691140

Kristin Anselmo

Role: CONTACT

kanselmo@metisfoundationusa.org

Other Identifiers

CDMRP-RC220169

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

E04634.1a

Identifier Type: OTHER

Identifier Source: secondary_id

Pro00076270

Identifier Type: -

Identifier Source: org_study_id