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

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.

• Examining the incidence of skin tumours (melanoma passenger are known) [Срок оценки: 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 [Срок оценки: Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline]
• Medical history [Срок оценки: Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline]
• Sensibility (2-point discrimination) [Срок оценки: Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline]
• Sensibility (Vibration) [Срок оценки: Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline]
• Sensibility (Temperature perception) [Срок оценки: Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline]
• Sensibility (Pain perception) [Срок оценки: Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline]
• Skin Thickness (DermaScan) [Срок оценки: Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline]
• Skin thickness (DermaLab Combo®) [Срок оценки: Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline]
• Health-related Quality of Life (HRQoL) [Срок оценки: Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline]
• Transepidermal water loss (TEWL) difference (DermaLab Combo®) [Срок оценки: Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline]
• Skin hydration difference (DermaLab Combo®) [Срок оценки: Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline]