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

Multicenter Cohort Study for the Use of Cultured Epithelial Autografts (CEA) or Cultured Dermal Epidermal Autografts (CDEA) in Severely Burned Patients

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Full Thickness Skin Defects; Burn Degree Second; Burn Degree Third; Skin Transplantation
• Intervention / Treatment: Other: Standard of Care (SOC)

Detailed Description

The Swisskera project is a multicenter, observational long-term outcomes study conducted at the three Swiss burn centers. It evaluates scar and skin quality after burn wound coverage with lab-grown keratinocyte-based grafts, specifically cultured epithelial autograft (CEA) and, where applicable, cultured dermal-epidermal autograft (CDEA). Eligible patients are those who sustained a burn injury and were treated with CEA and/or CDEA since the introduction of CEA in Switzerland (1985-2023). Participants are invited for a dedicated study visit. The study uses routinely collected clinical data (at minimum demographics and date/time of CEA/CDEA transplantation) together with standardized long-term clinical and instrument-based assessments. Participation requires written informed consent from the patient or an authorized legal representative; patients who decline participation or cannot attend a study visit (at a study site or at home) are excluded.

At the study visit, long-term scar and skin quality are quantified using within-subject comparisons between the previously transplanted CEA/CDEA area and a comparable healthy skin reference site. The Primary Endpoint is the long term skin and scar quality evaluated by the POSAS. Non-invasive measurements are performed with the DermaLab Combo® system and include skin thickness, transepidermal water loss (TEWL), hydration, elasticity, and colorimetry, each recorded in the transplanted area and compared to the matched healthy site to characterize residual functional and aesthetic differences many years after transplantation.

In addition, participants may opt into a minimally invasive tissue assessment. Optional 4-mm punch biopsies can be taken from previously CEA-transplanted skin for histological and immunohistochemical analyses of long-term tissue remodeling. Biopsies are performed under local anesthesia or during clinically indicated general anesthesia/analgosedation if the participant is undergoing such anesthesia for other reasons. Histological endpoints include collagen fiber density and deposition pattern, elastin fiber density, vascular development and pattern, nerve fiber ingrowth, inflammatory/immunological cell presence and distribution (e.g., granulocytes and macrophages), and melanocyte presence/distribution. Together, the clinical record review, standardized non-invasive skin measurements, and optional tissue-level analyses aim to provide a comprehensive characterization of long-term outcomes after CEA/CDEA treatment in Switzerland.

• Study Type: Observational
• Enrollment (Estimated): 236

Contacts and Locations

• Study Contact: Name: Sophie Böttcher, PD Dr. med.; Phone Number: +41442497228; Email: sophie.boettcher@kispi.uzh.ch
• Study Contact Backup: Name: Sophie Böttcher, PD Dr. med.; Phone Number: +41442496115; Email: studien.plastische@kispi.uzh.ch

Study Locations

• Switzerland
  • Canton of Zurich
    • Zurich, Canton of Zurich, Switzerland, 8091
      • University Hospital Zurich
      • Contact: Bong-Sung Kim, Prof Dr. med.; Phone Number: +41432538932; Email: bong-sung.kim@usz.ch
      • Principal Investigator: Bong-Sung Kim, Prof. Dr. med.
    • Zurich, Canton of Zurich, Switzerland, 8008
      • University Children's Hospital Zurich
      • Principal Investigator: Sophie Böttcher, PD Dr. med.
      • Contact: Sophie Böttcher, PD Dr. med.; Phone Number: +41442497228; Email: sophie.boettcher@kispi.uzh.ch
      • Contact: Sophie Böttcher, PD Dr. med.; Phone Number: +41442496115; Email: studien.plastische@kispi.uzh.ch
  • Lausanne
    • Lausanne, Lausanne, Switzerland, 1005
      • Centre Hospitalier Universitaire Vaudois
      • Principal Investigator: Anthony de Buys-Roessingh, Prof. Dr. med.
      • Contact: Philippe Abdel-Sayed, PhD; Phone Number: +41213146928; Email: philippe.abdel-sayed@chuv.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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); Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Examining the incidence of skin tumours (melanoma passenger are known)	With Dermatoscope evaluations. Additionally, suspicious skin lesions, will undergo optional dermatopathological assessment, utilizing shave or punch biopsies. If the patient chooses further dermatopathological evaluation, we will obtain the histological findings as well as the diagnostic report, and ensure they are followed up and documented.	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	The need for secondary surgery due to instable scars, hypertrophic scaring or contractures and replacement.	Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline
Medical history	Evaluation of relevant medical history that might influence the skin and scar quality today, such as accidents, chronic illness or substance abuse.	Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline
Sensibility (2-point discrimination)	Sensibility testing by 2-point discrimination focusing on comparing the sensibility difference between the transplanted CEA/CDEA area and the adjacent healthy skin. Unit of Measure: mm	Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline
Sensibility (Vibration)	Sensibility testing by vibration with a Rydel-Seiffer tuning fork focusing on comparing the sensibility difference between the transplanted CEA/CDEA area and the adjacent healthy skin. Unit of measure: Hz	Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline
Sensibility (Temperature perception)	Participants will report perceived warm and cold sensibility in the transplanted CEA/CDEA area compared with adjacent healthy skin (e.g., reduced, unchanged, or increased). Unit of measure: Categorical (reduced / unchanged / increased)	Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline
Sensibility (Pain perception)	Monofilament touch will be applied to the transplanted CEA/CDEA area and to adjacent healthy skin. Participants will rate how strongly they perceive the stimulus on a numeric rating scale from 1 (not perceived/very weak) to 10 (very strong). The outcome is the within-participant difference in ratings (transplanted minus healthy). Unit of measure: Numeric rating scale (1-10)	Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline
Skin Thickness (DermaScan)	The Dermascan will be used to measure the thickness of the dermal skin layer. Unit of Measure: mm	Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline
Skin thickness (DermaLab Combo®)	Skin thickness will be measured in the transplanted CEA/CDEA area and at a matched adjacent healthy skin reference site. The outcome is the within-participant difference (transplanted minus healthy). Unit of Measure: mm	Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline
Health-related Quality of Life (HRQoL)	Health-related quality of life (HRQoL) will be evaluated using the Short Form-12 (SF-12),a shorter version from the SF-36, which is a for burn cohorts validated score. The score will undergo comparison with a control group matched for gender and age, utilizing established norm values from the University of Lucerne. If a significant variance is identified, it will be further analyzed and compared with HRQoL data from analogous studies in the existing literature (to be defined).	Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline
Transepidermal water loss (TEWL) difference (DermaLab Combo®)	Description: TEWL will be measured in the transplanted area and at a matched healthy reference site. The outcome is the within-participant difference (transplanted minus healthy). Unit of Measure: g/m²/h	Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline
Skin hydration difference (DermaLab Combo®)	Description: Hydration will be measured in the transplanted area and at a matched healthy reference site. The outcome is the within-participant difference (transplanted minus healthy). Unit of Measure: Arbitrary units (device output)	Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline
Skin elasticity difference (DermaLab Combo®)	Description: Elasticity will be measured in the transplanted area and at a matched healthy reference site. The outcome is the within-participant difference (transplanted minus healthy). Unit of Measure: Arbitrary units (device output)	Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline
Erythema index difference (DermaLab Combo®)	Erythema index will be measured in the transplanted area and at a matched healthy reference site. The outcome is the within-participant difference (transplanted minus healthy). Unit of Measure: Index units (device output)	Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline
Melanin index difference (DermaLab Combo®)	Melanin index will be measured in the transplanted area and at a matched healthy reference site. The outcome is the within-participant difference (transplanted minus healthy). Unit of Measure: Index units (device output)	Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunhistochemical analyses	Exploratory histology/immunohistochemistry from optional 4-mm punch biopsies collected at the on-site study visit (0-2 per participant) from transplanted skin and, when available, matched healthy skin. Analyses will characterize tissue architecture and cellular features using standard staining panels. Results will be summarized descriptively; no formal hypothesis testing is planned.	Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline
Composite skin quality score (DermaLab Combo®) - z-score	A unitless composite score will be calculated by standardizing each DermaLab parameter (skin thickness, TEWL, hydration, elasticity, erythema index, melanin index) to z-scores and averaging them. The outcome is the within-participant difference in the composite score (transplanted minus matched healthy reference site). Unit of Measure: Unitless (z-score composite)	Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline

Collaborators and Investigators

• Sponsor: University Children's Hospital, Zurich
• Collaborators: University of Zurich; Swiss National Science Foundation; Centre Hospitalier Universitaire Vaudois

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: January 14, 2026
• First Submitted That Met QC Criteria: February 9, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 2025-01449; 10.005.785 (Other Grant/Funding Number: Swiss National Science Foundation (SNSF))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No