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Differential Pressure Distribution Orthosis by 3D Printing Process in the Treatment of Post-burn Hypertrophic Scarring

Study acronym: EPIDERM
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion dates: Jan 10, 2026 to Jan 10, 2027
    • Site contact updated
    v6
  2. Trial status: Not Yet Recruiting to Recruitingv5 Show 4 more changesShow less
    • Primary completion date: Jan 30, 2025 to Jan 10, 2026
    • Study completion date: Jan 30, 2026 to Jan 10, 2026
    • Start date changed from estimate of Jan 30, 2025 to Jan 10, 2025
    • Site details revised
  3. Start date: Dec 1, 2024 to Jan 30, 2025
    • Primary completion date: Dec 1, 2025 to Jan 30, 2025
    • Study completion date: Dec 1, 2026 to Jan 30, 2026
    v4
  4. Start date: Sep 1, 2024 to Dec 1, 2024
    • Primary completion date: Sep 1, 2025 to Dec 1, 2025
    • Study completion date: Sep 1, 2026 to Dec 1, 2026
    v3
  5. Start date: Jul 8, 2024 to Sep 1, 2024
    • Primary completion date: Jul 8, 2025 to Sep 1, 2025
    • Study completion date: Jul 8, 2026 to Sep 1, 2026
    v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a pilot, single-center, feasibility study to evaluate a new 3D printing method for ORDP design. To our knowledge, there is no technical or clinical evaluation of ORDPs, particularly in the treatment of hypertrophic scars. The aim of our study is therefore to assess the feasibility of an innovative method of designing ORDPs for the curative treatment of post-burn hypertrophic scars, using a 3D printing process, and to describe the procedures (production time and cost).
Trial Details
NCT Number NCT06487910
Lead Sponsor Centre Hospitalier Régional Metz-Thionville
Conditions
(from sponsor)		 Burns, Hypertrophic Scar
Related terms Burns, Cicatrix, Hypertrophic
Enrollment 25 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov