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ACTIVE NOT RECRUITING
NCT03227146
PHASE2

Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Adults and Adolescents

Sponsor: CUTISS AG

View on ClinicalTrials.gov

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

BIOLOGICAL

EHSG-KF

Transplantation of autologous dermo-epidermal skin substitute EHSG-KF to the experimental area

BIOLOGICAL

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