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.
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
236
Standard of Care
University Children's Hospital Zurich
Zurich, Canton of Zurich, Switzerland
University Hospital Zurich
Zurich, Canton of Zurich, Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Lausanne, Switzerland
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).
Time frame: Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline
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