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NCT Number: NCT07415577

The Use of Cultured (Dermal) Epithelial Autografts 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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

University Children's Hospital Zurich, Zurich, Canton of Zurich, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard of Care (SOC)

Other

Standard of Care

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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

  6. 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)

  7. 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)

  8. 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

  9. 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

  10. 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).

  11. 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

  12. 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)

  13. 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)

  14. 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)

  15. 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)

Other outcomes

  1. 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.

  2. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Sophie Böttcher, PD Dr. med.

CONTACT

[email protected]

+41442497228

Sophie Böttcher, PD Dr. med.

CONTACT

[email protected]

+41442496115

Sponsors and collaborators

Lead sponsor

University Children's Hospital, Zurich

Other

Collaborators

  • Centre Hospitalier Universitaire Vaudois
  • Swiss National Science Foundation
  • University of Zurich

Registry information

Official study title

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

Acronym: Swisskera

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Feb 17, 2026
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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