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

ConditionsSurgical WoundBurnsTrauma Injury
Trial statusRecruiting
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • SupraSDRM®

    Device

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

  • NovoSorb® BTM

    Device

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

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: SupraSDRM®Experimental treatment 1 intervention
Group B: SOC Skin SubstituteActive comparator 1 intervention

Trial outcomes

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.

Time frame
up to 5 weeks

Secondary outcomes

1

Clinical incidence of skin substitute infection

Incidence of infections and inflammatory response and scar development

Time frame
up to 5 weeks
2

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

Time frame
up to 5 weeks
3

Percentage graft survival as assessed 7 days after skin graft application

Percent of graft survival will be measured by clinical assessment

Time frame
7 days
4

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.

Time frame
up to 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Metis Foundation

Lead sponsor

The University of Texas Medical Branch, Galveston

Collaborator

United States Department of Defense

Collaborator

United States Army Institute of Surgical Research

Collaborator

Source ClinicalTrials.gov
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