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

Burns Clinical Trial

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)

Clinical Trial 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.

Clinical Trial 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, including the ratio of covered surface area to harvested surface area and scar quality, in comparison to meshed STSG. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03227146
Study type Interventional
Source CUTISS AG
Contact
Status Active, not recruiting
Phase Phase 2/Phase 3
Start date October 25, 2017
Completion date August 31, 2025
View Details
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