NCT06503406

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: The Metis Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	SupraSDRM®	SupraSDRM® Bidegradable Matrix Wound Dressing is a tri-polymber, Biodegrable dermal covering manufactured by PolyMedics Innovations, GmbH.
DEVICE	NovoSorb® BTM	NovoSorb® BTM absorbable synthetic wound dressing, PolyNovo Biomaterials, K172140

Timeline

• Start date: 2025-03-01
• Primary completion: 2025-10-01
• Completion: 2026-10-01
• First posted: 2024-07-16
• Last updated: 2025-02-21