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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Burns; Surgical Wound; Trauma Injury
• Intervention / Treatment: Device: SupraSDRM®; Device: NovoSorb® BTM

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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Victoria Diaz, RN; Phone Number: 2105691140; Email: Diaz@metisfoundationusa.org
• Study Contact Backup: Name: Kristin Anselmo; Email: kanselmo@metisfoundationusa.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: SupraSDRM®; SupraSDRM® Bidegradable Matrix Wound Dressing is a tri-polymber, Biodegrable dermal covering manufactured by PolyMedics Innovations, GmbH.
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.	Device: NovoSorb® BTM; NovoSorb® BTM absorbable synthetic wound dressing, PolyNovo Biomaterials, K172140

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical incidence of skin substitute infection	Incidence of infections and inflammatory response and scar development	up to 5 weeks
Days of skin graft application from time of SupraSDRM® or SoC application	The wounds will be assessed for their readiness for grafting by their treating surgeon at minimum weekly	up to 5 weeks
Percentage graft survival as assessed 7 days after skin graft application	Percent of graft survival will be measured by clinical assessment	7 days
Number of return trips to the OR	The wounds will be assessed by their care team as part of standard care procedures. Research personal will document any areas of concern or additional surgeries required.	up to 1 year
Skin graft contraction	Patient and Observer Scar Assessment Scale (POSAS) Questionnaire will be used to assess scaring and contraction. This scale uses a 1-10 rating scale with 1 being normal and 10 being worst imaginable outcome.	up to 1 year
Wound Pain scale 1-10	Patients will be asked to rate their pain 0-10 (0=no pain and 10=a lot of pain) at each visit	up to 1 year
Cost-effectiveness	looking at the overall length of stay in the hospital, the number of trips to the operating room and cost of skin substitute will help determine if the study dressing is more or less cost affective	up to 1 year

Collaborators and Investigators

• Sponsor: The Metis Foundation
• Collaborators: United States Department of Defense; The University of Texas Medical Branch, Galveston; The United States Army Institute of Surgical Research
• Investigators: Principal Investigator: Rodney Chan, MD, Metis Foundation

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: July 1, 2024
• First Submitted That Met QC Criteria: July 9, 2024
• First Posted (Actual): July 16, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 19, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Surgical Wound; Wounds and Injuries
• Other Study ID Numbers: Pro00076270; CDMRP-RC220169 (Other Grant/Funding Number: Congressionally Directed Medical Research Program); E04634.1a (Other Identifier: Office of Human and Animal Research Oversight)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No