The Use of Cultured (Dermal) Epithelial Autografts in Severely Burned Patients
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversity Children's Hospital, Zurich
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
The study population includes patients treated at the three Swiss burn centers who sustained a burn injury and received grafting with cultured epithelial autograft (CEA) and/or cultured dermal-epidermal autograft (CDEA) between 1985 and 2023. Participants must have available clinical data (at minimum demographics and the date/time of CEA/CDEA transplantation) and provide written informed consent (patient or authorized legal representative). Patients are excluded if they decline participation or are unable to attend a study visit at a study site or at home.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Standard of Care (SOC)
Other interventionStandard of Care
Treatment groups
236 Participants
are divided into 1 treatment groupGroup A: Cultured Epithelial Autografts and Cultured Dermal Epithelial Autografts1 intervention
Trial outcomes
Primary outcomes
1
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 BaselineSecondary outcomes
1
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 Baseline2
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 Baseline3
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 Baseline4
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 BaselineOther outcomes
1
Immunhistochemical analyses
Exploratory histology/immunohistochemistry from optional 4-mm punch biopsies collected at the on-site study visit (0-2 per participant) from transplanted skin and, when available, matched healthy skin. Analyses will characterize tissue architecture and cellular features using standard staining panels. Results will be summarized descriptively; no formal hypothesis testing is planned.
Time frame
Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline2
Composite skin quality score (DermaLab Combo®) - z-score
A unitless composite score will be calculated by standardizing each DermaLab parameter (skin thickness, TEWL, hydration, elasticity, erythema index, melanin index) to z-scores and averaging them. The outcome is the within-participant difference in the composite score (transplanted minus matched healthy reference site). Unit of Measure: Unitless (z-score composite)
Time frame
Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Children's Hospital, Zurich
Lead sponsor
University of Zurich
Collaborator
Centre Hospitalier Universitaire Vaudois
Collaborator
Swiss National Science Foundation
Collaborator
Source ClinicalTrials.gov
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