NCT06745557

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

A Multicentre, Intra-patient Randomised Controlled Phase III Study to Confirm the Efficacy and Safety of DenovoSkin™, a Bilayer Engineered Collagen-based Skin Graft Composed of Autologous Fibroblasts and Keratinocytes, for the Treatment of Patients with Deep Partial and Full-thickness Burns

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: CUTISS AG · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This multicentre phase III clinical trial will target adults and adolescents of 12 years and older with severe burns to confirm the efficacy and functionality of denovoSkin™ in achieving wound closure and reducing scarring in patients with deep partial and full-thickness burns as compared to split-thickness skin.

Conditions

• Burns

Interventions

Type	Name	Description
BIOLOGICAL	denovoSkin(TM)	Transplantation of autologous dermo-epidermal skin substitute denovoSkin(TM) to the experimental area
OTHER	STSG	Transplantation of autologous split-thickness skin to the control area

Timeline

• Start date: 2024-12-13
• Primary completion: 2026-12-31
• Completion: 2028-06-30
• First posted: 2024-12-20
• Last updated: 2025-01-28

Locations

1 site across 1 country: Netherlands