RecruitingPhase 3NCT06745557

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

Sponsor

CUTISS AG

Enrollment

70 participants

Start Date

Dec 13, 2024

Study Type

INTERVENTIONAL

Conditions

Burns

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.

Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying STSG and a biological treatment called denovoSkin(TM) for people with burns. The study is currently recruiting participants at 19 locations. People eligible for this study include aged 12 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALdenovoSkin(TM)

Transplantation of autologous dermo-epidermal skin substitute denovoSkin(TM) to the experimental area

OTHERSTSG

Transplantation of autologous split-thickness skin to the control area

Locations(19)

CHU de Liège Département de pharmacie hospitalière - Secteur Essais cliniques

Liège, Belgium

Hopital Edouard Herriot Centre des Brûlés de Lyon

Lyon, France

Pharmacie Hôpital Conception

Marseille, France

Centre Hospitalier Universitaire de Montpellier

Montpellier, France

BG Klinikum Unfallkrankenhaus Berlin

Berlin, Germany

BG Klinikum Bergmannstrost Halle

Halle, Germany

Medizinische Hochschule Hannover

Hanover, Germany

BG-Unfallklinik Murnau

Murnau am Staffelsee, Germany

Santobono-Pausilipon

Naples, Italy

Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli

Naples, Italy

AOU Padova

Padova, Italy

Rode Kruis Ziekenhuis

Beverwijk, Netherlands

Maasstad Hospital Dep. Burn Wound Centre

Rotterdam, Netherlands

Samodzielny Zakład Opieki Zdrowotnej z siedzibą w Łęcznej

Łęczna, Poland

Unidade de Queimados do CHUC

Coimbra, Portugal

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Hospital Universitario La Paz Edificio Traumatología

Madrid, Spain

Hospital Universitatrio y Politécnico La Fe

Valencia, Spain

Universtitätsspital Zürich

Zurich, Switzerland

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NCT06745557

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