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| Name | Class |
|---|---|
| University of Zurich | OTHER |
| Kantonsspital Aarau | OTHER |
| Kantonsspital Winterthur KSW | OTHER |
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The goal of this observational study is to compare a novel dermal substitute to a the current standard procedure in the treatment of full thickness skin defects.
The main questions aim to answer are:
• Is the skin elasticity treated with the novel dermal substitute better than the skin elasticity treated with the current standard procedure Participants skin elasticity will be measured by Cutometer® MPA-580 assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NovoSorb® BTM and STSG | Full thickness skin defect qualifying for coverage with the dermal substitute NovoSorb® BTM before transplantation with a split-thickness skin graft (STSG) according to clinical routine |
| |
| STSG alone | Full thickness skin defect qualifying for coverage with split-thickness skin graft (STSG) alone according to clinical routine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of care | Other | Standard of care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Skin elasticity after 1year post-transplantation | Comparison of skin elasticity of treated skin versus adjacent normal skin | 1 year post-transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Histological staining | Histological characterisation of epidermal and dermal components | within 1 year after skin transplantation |
| Skin color assessment | Changes in skin color |
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Inclusion Criteria:
Age: 1 to 75 years
Full-thickness skin defect qualifying for coverage with the dermal substitute NovoSorb® BTM before transplantation with a STSG:
Documented medical treatment decision of covering the full-thickness skin defects with either the two-step BTM/STSG procedure or with STSG alone or by using both techniques on different wound areas
Informed consent by patients/parents or other legal representative
Exclusion Criteria:
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The project population will consist of children and adults that received surgical coverage of full-thickness skin defects either the two-step BTM/STSG procedure or with STSG alone under routine conditions.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sophie Böttcher, MD | Contact | +41442497228 | sophie.boettcher@kispi.uzh.ch | |
| Vivienne Woodtli, dipl. med. | Contact | +41442497586 | vivenne.woodtli@kispi.uzh.ch |
| Name | Affiliation | Role |
|---|---|---|
| Sophie Böttcher, MD | University Children's Hospital, Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cantonal Hospital Aarau | Recruiting | Aarau | Canton of Aargau | 5001 | Switzerland |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Punch biopsies
| within 1 year after skin transplantation |
| Photographical assessment | Changes in graft-size | within 1 year after skin transplantation |
| Change of quality of life within one year after skin transplantation | Quality of life assessed with standard EuroQoL questionnaire | within 1 year after skin transplantation |
| Immunohistochemical analyses | Histological characterisation of mature BTM | 14-21 days after BTM transplantation |
| University Children's Hospital Zurich | Recruiting | Zurich | Canton of Zurich | 8032 | Switzerland |
|
| University Hospital Zurich | Recruiting | Zurich | Canton of Zurich | 8090 | Switzerland |
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| Cantonal Hospital Winterthur | Recruiting | Winterthur | Winterthur | 8400 | Switzerland |
|