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| Name | Class |
|---|---|
| University Hospital, Zürich | OTHER |
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The purpose of this study is the evaluation of the safety of autologous tissue-engineered dermal substitutes "denovoDerm" (first arm) and dermo-epidermal skin substitutes "denovoSkin" (second arm) transplanted onto the wound bed in children and adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| denovoDerm | Experimental | Autologous tissue-engineered dermal substitute |
|
| denovoSkin | Experimental | Autologous tissue-engineered dermo-epidermal skin substitute |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| denovoDerm | Biological | Transplantation of an autologous tissue-engineered dermal substitute, covered with autologous split-thickness skin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Assessment/reporting of local infection rate and graft take | denovoDerm: 4-6 days and 21 days after transplantation, denovoSkin 9-11 days and 21 days after transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Assessment/reporting of number of adverse events | until 90 days post transplantation |
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Inclusion Criteria:
Deep partial or full thickness skin defect of at least 9 cm2 requiring surgical wound coverage due to:
Informed consent by patients/parents or other legal representatives
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sophie Böttcher, PD Dr. med. | University Children's Hospital, Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Children's Hospital Zurich: denovoDerm | Zurich | Canton of Zurich | 8032 | Switzerland | ||
| University Children's Hospital Zurich: denovoSkin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39115183 | Derived | Schiestl C, Neuhaus K, Meuli M, Farkas M, Hartmann-Fritsch F, Elrod J, Bressan J, Reichmann E, Bottcher-Haberzeth S. Long-Term Outcomes of a Cultured Autologous Dermo-Epidermal Skin Substitute in Children: 5-Year Results of a Phase I Clinical Trial. J Burn Care Res. 2025 Mar 4;46(2):326-334. doi: 10.1093/jbcr/irae150. |
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| denovoSkin | Biological | Transplantation of autologous tissue-engineered dermo-epidermal skin substitute, no additional coverage needed |
|
| Zurich |
| Canton of Zurich |
| 8032 |
| Switzerland |
| ID | Term |
|---|---|
| D002056 | Burns |
| D017695 | Soft Tissue Injuries |
| D009336 | Necrosis |
| D002921 | Cicatrix |
| D012878 | Skin Neoplasms |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005355 | Fibrosis |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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