Clinical Trial

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

Study acronym: Swisskera
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Summary
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2026-02-09; most recent amendment 2026-05-20.
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 Burn Degree Second, Burn Degree Third, Skin Transplantation, Full Thickness Skin Defects
Enrollment 236 participants
Start Date 2026-12-01
Primary Completion 2029-12-31 (estimated)
Study Completion 2030-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-26