Multicenter Cohort Study for the Use of Cultured Epithelial Autografts (CEA) or Cultured Dermal Epidermal Autografts (CDEA) in Severely Burned Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 236
- 试验地点
- 3
- 主要终点
- Long-term outcome of scar and skin quality (POSAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Standard of Care (SOC) (Other)
结局指标
主要结局
Long-term outcome of scar and skin quality (POSAS)
时间窗: 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).
次要结局
- Examining the incidence of skin tumours (melanoma passenger are known)(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(Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline)
- Medical history(Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline)
- Sensibility (2-point discrimination)(Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline)
- Sensibility (Vibration)(Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline)
- Sensibility (Temperature perception)(Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline)
- Sensibility (Pain perception)(Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline)
- Skin Thickness (DermaScan)(Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline)
- Skin thickness (DermaLab Combo®)(Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline)
- Health-related Quality of Life (HRQoL)(Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline)
- Transepidermal water loss (TEWL) difference (DermaLab Combo®)(Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline)
- Skin hydration difference (DermaLab Combo®)(Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline)
- Skin elasticity difference (DermaLab Combo®)(Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline)
- Erythema index difference (DermaLab Combo®)(Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline)
- Melanin index difference (DermaLab Combo®)(Baseline Day 0 (= First contact with patient) Visit 1 up to 12 month after Baseline)