Burn Degree Second, Burn Degree Third, Full Thickness Skin Defects, Skin Transplantation
Conditions
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.
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.
Interventions
OTHERStandard of Care (SOC)
Standard of Care
Sponsors
University Children's Hospital, Zurich
University of Zurich
Centre Hospitalier Universitaire Vaudois
Swiss National Science Foundation
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Long-term outcome of scar and skin quality (POSAS) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | The need for secondary surgery due to instable scars, hypertrophic scaring or contractures and replacement. |
| Medical history | 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. |
| Sensibility (2-point discrimination) | 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 |
| Sensibility (Vibration) | 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 |
| Sensibility (Temperature perception) | 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) |
| Sensibility (Pain perception) | 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) |
| Skin Thickness (DermaScan) | 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 |
| Skin thickness (DermaLab Combo®) | 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 |
| Health-related Quality of Life (HRQoL) | 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). |
| Transepidermal water loss (TEWL) difference (DermaLab Combo®) | 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 |
| Skin hydration difference (DermaLab Combo®) | 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) |
| Skin elasticity difference (DermaLab Combo®) | 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) |
| Erythema index difference (DermaLab Combo®) | 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) |
| Melanin index difference (DermaLab Combo®) | 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) |
Countries
Switzerland
Contacts
CONTACTSophie Böttcher, PD Dr. med.
Outcome results
None listed