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

Not Applicable

Not yet recruiting

• Conditions: Trauma Injury; Surgical Wound; Burns
• Interventions: Device: SupraSDRM®; Device: NovoSorb® BTM

• Registration Number: NCT06503406
• Lead Sponsor: The Metis Foundation

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.

Study Timeline

• Study First Submitted: 2024-07-01
• Study First Submitted QC: 2024-07-09
• Study First Posted: 2024-07-16
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-21
• Study Start: 2025-03
• Primary Completion: 2025-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SupraSDRM®	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.
SOC Skin Substitute	NovoSorb® BTM	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 Measures

Name	Time	Method
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.	up to 5 weeks	This endpoint is based on the ability of the dermal substitute to rapidly vascularize and allow for placement of a skin graft.

Secondary Outcome Measures

Name	Time	Method
Days of skin graft application from time of SupraSDRM® or SoC application	up to 5 weeks	The wounds will be assessed for their readiness for grafting by their treating surgeon at minimum weekly
Skin graft contraction	up to 1 year	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.
Percentage graft survival as assessed 7 days after skin graft application	7 days	Percent of graft survival will be measured by clinical assessment
Wound Pain scale 1-10	up to 1 year	Patients will be asked to rate their pain 0-10 (0=no pain and 10=a lot of pain) at each visit
Clinical incidence of skin substitute infection	up to 5 weeks	Incidence of infections and inflammatory response and scar development
Number of return trips to the OR	up to 1 year	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.
Cost-effectiveness	up to 1 year	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