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

NCT06745557 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-01-28

No results posted yet for this study

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

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

Sponsors & Collaborators

  • RCTs

    collaborator INDUSTRY

  • CUTISS AG

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-13
Primary Completion
2026-12-31
Completion
2028-06-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06745557 on ClinicalTrials.gov