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

May 20, 2026 updated by: University Children's Hospital, Zurich

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
236

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Switzerland
    • Canton of Zurich
      • Zurich, Canton of Zurich, Switzerland, 8091
        • University Hospital Zürich
        • Contact:
        • 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:
        • Contact:
    • Lausanne
      • Lausanne, Lausanne, Switzerland, 1005
        • Centre hospitalier universitaire vaudois
        • Principal Investigator:
          • Anthony de Buys-Roessingh, Prof. Dr. med.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Long-term outcome of scar and skin quality (POSAS)
Time Frame: Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Examining the incidence of skin tumours (melanoma passenger are known)
Time Frame: Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline
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
Time Frame: Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline
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
Time Frame: Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline
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)
Time Frame: Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline

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

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

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

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

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

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

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

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

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

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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Immunhistochemical analyses
Time Frame: Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline
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
Time Frame: Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline

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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Children's Hospital, Zurich

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Zurich
Swiss National Science Foundation
Centre Hospitalier Universitaire Vaudois

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 14, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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