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

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.

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.

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