Burn Degree SecondSwisskeraNCT07415577
The Use of Cultured (Dermal) Epithelial Autografts in Severely Burned Patients
An observational study of Burn Degree Second and Burn Degree Third, run by University Children's Hospital, Zurich at 3 sites in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Burn Degree Second, Burn Degree Third, Skin Transplantation
- How many people
- 236 participants
- Where
- 3 sitesSwitzerland
- Study dates
- 1 Dec 2026to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland3 sites
Centre Hospitalier Universitaire Vaudois
Lausanne, Lausanne, 1005
Philippe Abdel-Sayed, PhD, +41213146928, philippe.abdel-sayed@chuv.ch
Anthony de Buys-Roessingh, Prof. Dr. med.
University Children's Hospital Zurich
Zurich, Canton of Zurich, 8008
Sophie Böttcher, PD Dr. med., +41442497228, sophie.boettcher@kispi.uzh.ch
Sophie Böttcher, PD Dr. med., +41442496115, studien.plastische@kispi.uzh.ch
University Hospital Zurich
Zurich, Canton of Zurich, 8091
Bong-Sung Kim, Prof Dr. med., +41432538932, bong-sung.kim@usz.ch
Bong-Sung Kim, Prof. Dr. med.
About this study
Official title: 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.
Read the 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.
- Being tested
- Standard of Care (SOC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care (SOC)Other
Standard of Care
| Study group | Role | What they receive |
|---|---|---|
| Cultured Epithelial Autografts and Cultured Dermal Epithelial Autografts | The study population comprises patients treated at the three Swiss burn centers who sustained a burn injury and underwent grafting with cultured epithelial autograft (CEA) and/or cultured dermal-epidermal autograft (CDEA) since the introduction of CEA in Switzerland (1985-2023), with available clinical data (at minimum demographics and the date/time of CEA/CDEA transplantation) and written informed consent from the patient or an authorized legal representative. Receives: Other: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline
Secondary outcomes (15)
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.
Measured: 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
The need for secondary surgery due to instable scars, hypertrophic scaring or contractures and replacement.
Measured: Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline
Medical history
Evaluation of relevant medical history that might influence the skin and scar quality today, such as accidents, chronic illness or substance abuse.
Measured: Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline
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
Measured: Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline
Sensibility (Vibration)
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
Measured: Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline
Sensibility (Temperature perception)
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)
Measured: Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline
Sensibility (Pain perception)
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)
Measured: Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline
Skin Thickness (DermaScan)
The Dermascan will be used to measure the thickness of the dermal skin layer. Unit of Measure: mm
Measured: Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline
Skin thickness (DermaLab Combo®)
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
Measured: Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline
Health-related Quality of Life (HRQoL)
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).
Measured: Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline
Transepidermal water loss (TEWL) difference (DermaLab Combo®)
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
Measured: Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline
Skin hydration difference (DermaLab Combo®)
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)
Measured: Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline
Skin elasticity difference (DermaLab Combo®)
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)
Measured: Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline
Erythema index difference (DermaLab Combo®)
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)
Measured: Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline
Melanin index difference (DermaLab Combo®)
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)
Measured: Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start1 Dec 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn Degree SecondStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich, Centre Hospitalier Universitaire Vaudois, Swiss National Science Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07415577
- Sponsor's protocol ID
- 2025-01449
- Other IDs
- 10.005.785, 2025
- Acronym
- Swisskera
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Cohort Study for the Use of Cultured Epithelial Autografts (CEA) or Cultured Dermal Epidermal Autografts (CDEA) in Severely Burned Patients
- ClinicalTrials.gov ID
- NCT07415577
- Acronym / sponsor ID
- Swisskera / 2025-01449
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Collaborators
- University of Zurich, Centre Hospitalier Universitaire Vaudois, Swiss National Science Foundation
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cultured Epithelial Autografts and Cultured Dermal Epithelial Autografts | – | Other: Standard of Care (SOC)The study population comprises patients treated at the three Swiss burn centers who sustained a burn injury and underwent grafting with cultured epithelial autograft (CEA) and/or cultured dermal-epidermal autograft (CDEA) since the introduction of CEA in Switzerland (1985-2023), with available clinical data (at minimum demographics and the date/time of CEA/CDEA transplantation) and written informed consent from the patient or an authorized legal representative. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of Care (SOC)Standard of Care | Other | Cultured Epithelial Autografts and Cultured Dermal Epithelial Autografts |
Primary outcome
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
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).
15 secondary outcomes
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
Skin elasticity difference (DermaLab Combo®)
Time frame: Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline
Erythema index difference (DermaLab Combo®)
Time frame: Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline
Melanin index difference (DermaLab Combo®)
Time frame: Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burn Degree Second and Burn Degree Third, run by University Children's Hospital, Zurich at 3 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophie Böttcher, PD Dr. med. (+41442497228, sophie.boettcher@kispi.uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.