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The Use of Cultured (Dermal) Epithelial Autografts in Severely Burned Patients

Study acronym: Swisskera
StatusNot Yet Recruiting
PhaseNot specified
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv3
  2. Primary completion date: Nov 1, 2027 to Dec 31, 2029v2 Show 5 more changesShow less
    • Start date: Jun 1, 2026 to Dec 1, 2026
    • Study completion date: May 1, 2028 to Dec 31, 2030
    • Study sites revised (3)
    • Collaborators: 2 to 3
    • Study title shortened, about 6 words
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 Swisskera project is a multicenter follow-up study at the three Swiss burn centers evaluating long-term outcomes after burn wound coverage with lab-grown epithelial grafts, specifically cultured epithelial autograft (CEA) and, where applicable, cultured dermal-epidermal autograft (CDEA). Patients who received CEA/CDEA between 1985 and 2023 will be invited for a study visit , using available clinical records and standardized long-term scar and skin assessments. Long-term skin quality will be evaluated by comparing the previously transplanted area with a matched healthy skin reference site using non-invasive measurements (e.g., thickness, transepidermal water loss, hydration, elasticity, and color). Optional small punch biopsies may be obtained from transplanted areas (under local anesthesia or during clinically indicated anesthesia) for histological and immunohistochemical characterization of scar tissue remodeling, including collagen and elastin architecture, vascularization, nerve fiber ingrowth, inflammatory cell patterns, and melanocyte distribution.
Trial Details
NCT Number NCT07415577
Lead Sponsor University Children's Hospital, Zurich
Collaborators: University of Zurich, Centre Hospitalier Universitaire Vaudois, Swiss National Science Foundation
Conditions
(from sponsor)		 Burn Degree Second, Burn Degree Third, Skin Transplantation, Full Thickness Skin Defects
Enrollment 236 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov