Clinical trial NCT06503406: A Prospective Study Using SupraSDRM® in Promoting Healing and Reducing the Time to Grafting of Full-thickness Wounds
Official title: A Prospective Study Using SupraSDRM® in Promoting Healing and Reducing the Time to Grafting of Full-thickness Wounds
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Surgical Wound
Burns
Trauma Injury
Lead sponsor: The Metis Foundation
Sponsor class: OTHER
Collaborators: name: The University of Texas Medical Branch, Galveston
name: United States Department of Defense
name: The United States Army Institute of Surgical Research
First posted: 2024-07-16
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: up to 5 weeks
Secondary outcomes:
measure: Clinical incidence of skin substitute infection
timeFrame: up to 5 weeks
measure: Days of skin graft application from time of SupraSDRM® or SoC application
timeFrame: up to 5 weeks
measure: Percentage graft survival as assessed 7 days after skin graft application
timeFrame: 7 days
measure: Number of return trips to the OR
timeFrame: up to 1 year
measure: Skin graft contraction
timeFrame: up to 1 year
measure: Wound Pain scale 1-10
timeFrame: up to 1 year
measure: Cost-effectiveness
timeFrame: up to 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Metis Foundation
name: Rodney Chan, MD
role: PRINCIPAL_INVESTIGATOR
References: