Actively Recruiting

Phase 3
Age: 12Years +
All Genders
NCT06745557

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

Led by CUTISS AG · Updated on 2025-01-28

70

Participants Needed

1

Research Sites

185 weeks

Total Duration

On this page

Sponsors

C

CUTISS AG

Lead Sponsor

R

RCTs

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 12Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with deep partial or full-thickness thermal burns covering 20% or more of total body surface area (TBSA) requiring excision and standard treatment
  • Patients aged 12 years or older
  • Signed informed consent from patient or legally authorized representative
Not Eligible

You will not qualify if you...

  • Burn wounds only on the head and neck
  • Patients who can have all areas grafted in a single surgery earlier than denovoSkin14 manufacturing allows
  • Active infection with hepatitis B, hepatitis C, HIV, or Treponema pallidum
  • Medical conditions that may significantly delay wound healing, including high HbA1c or systemic skin/connective tissue diseases
  • Pre-existing blood clotting disorders outside normal ranges
  • History of severe allergic reactions to amphotericin B, gentamicin, penicillin, streptomycin, or bovine collagen derivatives
  • Previous treatment with denovoSkin14
  • Participation in another clinical trial within 60 days (for monoclonal antibodies) or 30 days (for other investigational products)
  • Unable or unwilling to follow study procedures
  • Pregnant or breastfeeding women
  • Women of childbearing potential not using highly effective birth control and unwilling to undergo pregnancy testing
  • Investigator or related personnel involved in the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Rode Kruis Ziekenhuis

Beverwijk, Netherlands, 1942

Actively Recruiting

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Research Team

D

Daniela Marino

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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