A Prospective Study Using SupraSDRM® in Promoting Healing and Reducing the Time to Grafting of Full-thickness Wounds
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: SupraSDRM® (Device)
SOC Skin Substitute
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.
Intervention: NovoSorb® BTM (Device)
Outcomes
Primary Outcomes
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.
Time Frame: 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 Outcomes
- Days of skin graft application from time of SupraSDRM® or SoC application(up to 5 weeks)
- Skin graft contraction(up to 1 year)
- Percentage graft survival as assessed 7 days after skin graft application(7 days)
- Wound Pain scale 1-10(up to 1 year)
- Clinical incidence of skin substitute infection(up to 5 weeks)
- Number of return trips to the OR(up to 1 year)
- Cost-effectiveness(up to 1 year)