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Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Adults and Adolescents
Sponsor: CUTISS AG
Summary
This phase IIb trial aims to evaluate the efficacy and safety of EHSG-KF (synonym denovoSkin) in comparison to meshed STSG in adults and adolescents with partial deep dermal and full thickness burns.
Official title: A Phase IIb, Prospective, Intra-patient Randomised Controlled, Multicentre Study to Evaluate the Safety and Efficacy of an Autologous Bio-engineered Dermo-epidermal Skin Substitute (EHSG-KF) for the Treatment of Partial Deep Dermal and Full Thickness Burns in Adults and Adolescents in Comparison to Autologous Split-thickness Skin Grafts (STSG)
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
14
Start Date
2017-10-25
Completion Date
2025-12-31
Last Updated
2025-12-08
Healthy Volunteers
No
Conditions
Interventions
EHSG-KF
Transplantation of autologous dermo-epidermal skin substitute EHSG-KF to the experimental area
STSG
Transplantation of autologous split-thickness skin graft to the control area
Locations (6)
Chirurgia Plastica e Centro Grandi Ustioni Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli
Naples, Italy
Unità di Chirurgia Plastica e Ustioni Ospedale Santobono
Naples, Italy
Rode Kruis Ziekenhuis
Beverwijk, Netherlands
Maasstad Ziekenhuis
Rotterdam, Netherlands
University Children's Hospital Zurich
Zurich, Canton of Zurich, Switzerland
University Hospital Zurich
Zurich, Switzerland