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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorThe Metis Foundation

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Study wound may not include areas of the face, and neck and genitalia.

Wound with metal hardware exposure

Pressure sores

Wounds with residual malignancy

Trial design

Treatments tested in this trial

  • SupraSDRM®
  • NovoSorb® BTM

Treatment groups

24 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

The Metis Foundation

Lead sponsor

The University of Texas Medical Branch, Galveston

Collaborator

United States Department of Defense

Collaborator

The United States Army Institute of Surgical Research

Collaborator