Suprathel® Use During Prolonged Field Care to Promote Healing and Reduce the Need for Grafting of Burn Wounds
Part of paid clinical trials in Chapel Hill, North Carolina.
- Sponsor
- The Metis Foundation
- Study ID
- NCT05462860
- Status
- Recruiting
Conditions
- Burns
- Wound of Skin
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Suprathel® — OTHERApplication of standard of care dressing.®
Study Details
The purpose of this study is to determine the effect to which Suprathel® (Polymedics Innovations GmbH, Denkendorf, Germany) can reduce the need for grafting compared to Standard of Care (SoC). Furthermore, the study intends to evaluate if Suprathel® allows for a reduction of reduction of pain, infection, provider workload, scar development and costs compared to SoC.
Key Dates
- Start date
- Sep 18, 2024
- Status verified
- Apr 2025
- Primary completion
- Dec 29, 2025
- Completion
- Jun 29, 2026
Study Design
- Enrollment
- 21 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Suprathel® dressingThe Suprathel® dressing will be applied to the wound site after standard of care cleaning and debridement. The dressing will be maintained according to the manufacturer's instructions for use
- Active Comparator: Standard of CareThe Standard of care as prescribed will be followed for the dressing application for the wound site. Dressings will be applied to the wound site after standard of care cleaning and debridement.
Primary Outcome Measure
Need for autograft application [ Time Frame: 21 days ]
Central Contacts
- Victoria Diaz, RN2105691140
- Kristin Anselmo
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| North Carolina Jaycee Burn Center | Chapel Hill | North Carolina | 27599 | Carter Booker King, MD (PRINCIPAL_INVESTIGATOR) |
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