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A Phase I, Two Armed, Open, Prospective and Multicentre Study to Evaluate the Safety of Autologous Tissue-engineered Dermal Substitutes and Dermo-epidermal Skin Substitutes for the Treatment of Large Deep Partial and Full Thickness Skin Defects in Children and Adults
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.
Details
| Lead sponsor | University of Zurich |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 12 |
| Start date | 2014-05 |
| Completion | 2021-03 |
Conditions
- Burn Injury
- Soft Tissue Injury
- Skin Necrosis
- Scars
- Congenital Giant Nevus
- Skin Tumors
Interventions
- denovoDerm
- denovoSkin
Primary outcomes
- Safety — denovoDerm: 4-6 days and 21 days after transplantation, denovoSkin 9-11 days and 21 days after transplantation
Assessment/reporting of local infection rate and graft take
Countries
Switzerland