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® — OTHER
    Application 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® dressing
    The 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 Care
    The 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

Locations (1)

FacilityCityStateZIPSite coordinators
North Carolina Jaycee Burn CenterChapel HillNorth Carolina27599
Carter
Booker King, MD (PRINCIPAL_INVESTIGATOR)

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