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SASS 2 : Self Assembled Skin Substitute for the Autologous Treatment of Severe Burn Wounds in Acute Stage of Burn Trauma

StatusRecruiting
PhasePhase 1/2
Started
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Record History

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  1. Study completion pushed from Jan 2029 to Jan 31, 2029
    • Study sites: 7 to 8
    v13
  2. Site details revised at 1 of 7 sitesv12
  3. Enrollment target: 17 to 52v11 Show 7 more changesShow less
    • Primary completion date: Jan 2024 to Jan 2028
    • Start date: Jan 2015 to Dec 2015
    • Primary endpoints revised (3)
    • Study completion date: Jan 2025 to Jan 2029
    • Interventions: Self assembled skin substitute (SASS) (Biological), Split-thickness autograft (Procedure) to Self assembled skin substitute (SASS) (Biological)
    • Secondary endpoints revised (6)
    • Study arms: 2 to 1
  4. Study sites: 6 to 7v10
  5. Study sites: 5 to 6v9
Show 7 earlier versionsHide 7 earlier versions
  1. Study sites: 2 to 5
    • Secondary endpoints revised (6)
    v8
  2. Primary completion date: Jan 2020 to Jan 2024
    • Study completion date: Jan 2021 to Jan 2025
    v7
  3. Re-verified, no change to tracked fieldsv6
  4. Study completion date: Jan 2021
    • Site details revised at 1 of 2 sites
    v5
  5. 2 versions Re-verified since Jan 27, 2016, no change to tracked fieldsv3-v4
  6. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 2 of 2 sites
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 clinical trial is designed to assess the safety, effectiveness and benefits of Self Assembled Skin Substitute SASS grafts as a permanent skin replacement for the treatment of full-thickness burn wounds that require permanent coverage where the availability of donor sites is limited.
Trial Details
NCT Number NCT02350205
Lead Sponsor CHU de Quebec-Universite Laval
Conditions
(from sponsor)		 Burns
Related terms Burns
Enrollment 52 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov