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Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Children

NCT03229564 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-05-22

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 children 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
0 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-25
Primary Completion
2026-06-30
Completion
2028-06-30

Countries

  • Italy
  • Netherlands
  • Switzerland

Study Locations

More Related Trials

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 NCT03229564 on ClinicalTrials.gov