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Suprathel® Use During Prolonged Field Care to Promote Healing and Reduce the Need for Grafting of Burn Wounds

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Dec 29, 2025 → Dec 9, 2026
See other at-risk trials from The Metis Foundation

Record History

  1. Notable Primary completion pushed from Dec 29, 2025 to Dec 9, 2026
    • Enrollment closed, study ongoing
    • Study completion pushed from Jun 29, 2026 to Dec 9, 2026
    • Site details revised
    v7
  2. Minor Primary completion date: Sep 29, 2025 to Dec 29, 2025
    • Study completion date: Sep 29, 2025 to Jun 29, 2026
    v6
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Aug 15, 2024 to Sep 18, 2024
    v5
  4. Minor Re-verified, no change to tracked fieldsv4
  5. Notable Primary and study completion dates: Sep 29, 2024 to Sep 29, 2025
    • Start date: Jan 15, 2023 to Aug 15, 2024
    v3
  6. Notable Start date: Sep 15, 2022 to Jan 15, 2023v2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05462860
Lead Sponsor The Metis Foundation
Conditions
(from sponsor)
Wound of Skin, Burns
Related terms Burns
Enrollment 21 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov