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

NCT06503406 | Not Yet Recruiting

• 3 other identifiers: Pro00076270CDMRP-RC220169E04634.1a
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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.

  This endpoint is based on the ability of the dermal substitute to rapidly vascularize and allow for placement of a skin graft.

  up to 5 weeks

Secondary Outcomes (7)

• Clinical incidence of skin substitute infection

  up to 5 weeks

• Days of skin graft application from time of SupraSDRM® or SoC application

  up to 5 weeks

• Percentage graft survival as assessed 7 days after skin graft application

  7 days

• Number of return trips to the OR

  up to 1 year

• Skin graft contraction

  up to 1 year

Study Arms (2)

SupraSDRM®

EXPERIMENTAL

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.

Device: SupraSDRM®

SOC Skin Substitute

ACTIVE COMPARATOR

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.

Device: NovoSorb® BTM

Interventions

SupraSDRM® DEVICE

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

SupraSDRM®

NovoSorb® BTM DEVICE

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

SOC Skin Substitute

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Metis Foundation: lead
• The University of Texas Medical Branch, Galveston: collaborator
• United States Department of Defense: collaborator
• The United States Army Institute of Surgical Research: collaborator

MeSH Terms

Conditions

Surgical Wound; Burns; Accidental Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Rodney Chan, MD

  Metis Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Victoria Diaz, RN

CONTACT

2105691140; Diaz@metisfoundationusa.org

Kristin Anselmo

CONTACT

kanselmo@metisfoundationusa.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 16, 2024
• Study Start: March 1, 2025
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share