Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Adults
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Burns
- Type
- Interventional
- Phase
- Phase 2Phase 3
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 12 years and 125 years
- Gender
- Both males and females
Description
This multicentre phase IIb clinical trial will target adults and adolescents with severe burns to elucidate the benefit of a tissue-engineered autologous skin substitute for the patient group with the highest mortality rates. Particular emphasis, apart from safety, will be placed on efficacy, includ...
This multicentre phase IIb clinical trial will target adults and adolescents with severe burns to elucidate the benefit of a tissue-engineered autologous skin substitute for the patient group with the highest mortality rates. Particular emphasis, apart from safety, will be placed on efficacy, including the ratio of covered surface area to harvested surface area and scar quality, in comparison to meshed STSG.
Tracking Information
- NCT #
- NCT03227146
- Collaborators
- Wyss Zurich
- Julius Clinical, The Netherlands
- Sintesi Research Srl
- University Hospital, Zürich
- CUTISS AG
- Investigators
- Study Chair: Clemens Schiestl, Prof. University Children's Hospital, Zurich
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