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

NCT03227146 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2025-12-08

No results posted yet for this study

Summary

This phase IIb trial aims to evaluate the efficacy and safety of EHSG-KF (synonym denovoSkin) in comparison to meshed STSG in adults and adolescents with partial deep dermal and full thickness burns.

Conditions

  • Burns

Interventions

BIOLOGICAL

EHSG-KF

Transplantation of autologous dermo-epidermal skin substitute EHSG-KF to the experimental area

BIOLOGICAL

STSG

Transplantation of autologous split-thickness skin graft to the control area

Sponsors & Collaborators

  • Wyss Zurich

    collaborator UNKNOWN

  • Julius Clinical

    collaborator INDUSTRY

  • Sintesi Research Srl

    collaborator INDUSTRY

  • University Hospital, Zürich

    collaborator OTHER

  • University of Zurich

    collaborator OTHER

  • CUTISS AG

    lead INDUSTRY

Principal Investigators

  • Clemens Schiestl, Prof. · University Children's Hospital, Zurich

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-25
Primary Completion
2022-11-30
Completion
2025-12-31

Countries

  • Italy
  • Netherlands
  • Switzerland

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 NCT03227146 on ClinicalTrials.gov