The Use of Cultured (Dermal) Epithelial Autografts in Severely Burned Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard of Care (SOC).
- Who it may be relevant to
- Registry conditions: Burn Degree Second, Burn Degree Third, Skin Transplantation, Full Thickness Skin Defects. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Multicenter Cohort Study for the Use of Cultured Epithelial Autografts (CEA) or Cultured Dermal Epidermal Autografts (CDEA) in Severely Burned Patients
Overview
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
- Other Standard of Care (SOC)
Standard of Care
Primary outcome measures
- 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]
Secondary outcome measures (12)
- 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]
- 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]
- Medical history [Time frame: Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline]
- Sensibility (2-point discrimination) [Time frame: Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline]
- Sensibility (Vibration) [Time frame: Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline]
- Sensibility (Temperature perception) [Time frame: Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline]
- Sensibility (Pain perception) [Time frame: Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline]
- Skin Thickness (DermaScan) [Time frame: Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline]
- Skin thickness (DermaLab Combo®) [Time frame: Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline]
- Health-related Quality of Life (HRQoL) [Time frame: Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline]
- Transepidermal water loss (TEWL) difference (DermaLab Combo®) [Time frame: Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline]
- Skin hydration difference (DermaLab Combo®) [Time frame: Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Switzerland · 3 centers
- University Children's Hospital Zurich — Zurich
- University Hospital Zurich — Zurich
- Centre Hospitalier Universitaire Vaudois — Lausanne
Identifiers
NCT: NCT07415577 · 2025-01449 · 10.005.785