NCT03227146

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

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)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: CUTISS AG · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Burns

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-10-25
• Primary completion: 2022-11-30
• Completion: 2025-12-31
• First posted: 2017-07-24
• Last updated: 2025-12-08

Locations

6 sites across 3 countries: Italy, Netherlands, Switzerland