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RECRUITING
NCT06745557
PHASE3

Phase III 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 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.

Official title: 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

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2024-12-13

Completion Date

2028-06-30

Last Updated

2025-01-28

Healthy Volunteers

No

Conditions

Interventions

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

Locations (1)

Rode Kruis Ziekenhuis

Beverwijk, Netherlands