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

NCT07415577 | Not Yet Recruiting

• 2 other identifiers: 2025-0144910.005.785
• Study Type: observational
• Target: 236
• Locations: 1 country
• Sites: 3

Brief 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; Full Thickness Skin Defects; Skin Transplantation

Outcome Measures

Primary Outcomes (1)

• Long-term outcome of scar and skin quality (POSAS)

  The primary endpoint of this study is to assess scar quality in patients who have received a CEA within the past 40 years, as measured by the Patient and Observer Scar Assessment Scale (POSAS).

  Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline

Secondary Outcomes (15)

• Examining the incidence of skin tumours (melanoma passenger are known)

  Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline

• Evaluation of the requirement of secondary reconstructive surgical procedures and/or additional coverage of the transplanted CEAs/CDEAs

  Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline

• Medical history

  Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline

• Sensibility (2-point discrimination)

  Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline

• Sensibility (Vibration)

  Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline

Other Outcomes (2)

• Immunhistochemical analyses

  Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline

• Composite skin quality score (DermaLab Combo®) - z-score

  Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline

Study Arms (1)

Cultured Epithelial Autografts and Cultured Dermal Epithelial Autografts

The study population comprises patients treated at the three Swiss burn centers who sustained a burn injury and underwent grafting with cultured epithelial autograft (CEA) and/or cultured dermal-epidermal autograft (CDEA) since the introduction of CEA in Switzerland (1985-2023), with available clinical data (at minimum demographics and the date/time of CEA/CDEA transplantation) and written informed consent from the patient or an authorized legal representative.

Other: Standard of Care (SOC)

Interventions

Standard of Care (SOC) OTHER

Standard of Care

Cultured Epithelial Autografts and Cultured Dermal Epithelial Autografts

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes patients treated at the three Swiss burn centers who sustained a burn injury and received grafting with cultured epithelial autograft (CEA) and/or cultured dermal-epidermal autograft (CDEA) between 1985 and 2023. Participants must have available clinical data (at minimum demographics and the date/time of CEA/CDEA transplantation) and provide written informed consent (patient or authorized legal representative). Patients are excluded if they decline participation or are unable to attend a study visit at a study site or at home.

You may qualify if:

• Patients who have undergone treatment at the three Swiss burn centres and received grafts utilizing CEA since the introduction of the CEA technique in Switzerland (from 1985 to 2023) will be invited to participate in this study.
• Availability of clinical data, including at minimum demographic information and the date and time of CEA/CDEA transplantation.
• Signed informed consent from the patient or his/her legal representative/relatives.

You may not qualify if:

• Refusal of participation in the study by the patient or his/her legal representative/relatives.
• Patients, who are, of any reason, unable to attend a study visit at one of the study sites or in their home

Sponsors & Collaborators

• University Children's Hospital, Zurich: lead
• University of Zurich: collaborator
• Centre Hospitalier Universitaire Vaudois: collaborator
• Swiss National Science Foundation: collaborator

Study Sites (3)

University Children's Hospital Zurich

Zurich, Canton of Zurich, 8008, Switzerland

Location

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, Lausanne, 1005, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Punch biopsies

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Sophie Böttcher, PD Dr. med.

CONTACT

+41442497228; sophie.boettcher@kispi.uzh.ch

Sophie Böttcher, PD Dr. med.

CONTACT

+41442496115; studien.plastische@kispi.uzh.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: February 17, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (3)