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

NCT07415577 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 236

Last updated 2026-05-26

No results posted yet for this study

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.

Conditions

  • Burn Degree Second
  • Burn Degree Third
  • Skin Transplantation
  • Full Thickness Skin Defects

Interventions

OTHER

Standard of Care (SOC)

Standard of Care

Sponsors & Collaborators

  • University of Zurich

    collaborator OTHER

  • Centre Hospitalier Universitaire Vaudois

    collaborator OTHER

  • Swiss National Science Foundation

    collaborator OTHER

  • University Children's Hospital, Zurich

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-01
Primary Completion
2029-12-31
Completion
2030-12-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07415577 on ClinicalTrials.gov