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A Phase IIb, Prospective, Intra-patient Randomised Controlled, Multicentre Study to Evaluate the Safety and Efficacy of an Autologous Bio-engineered Dermo-epidermal Skin Substitute (EHSG-KF) for the Treatment of Partial Deep Dermal and Full Thickness Burns in Children in Comparison to Autologous Split-thickness Skin Grafts (STSG)

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A Phase IIb, Prospective, Intra-patient Randomised Controlled, Multicentre Study to Evaluate the Safety and Efficacy of an Autologous Bio-engineered Dermo-epidermal Skin Substitute (EHSG-KF) for the Treatment of Partial Deep Dermal and Full Thickness Burns in Children in Comparison to Autologous Split-thickness Skin Grafts (STSG)

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 28 Feb 2025

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At a glance

  • Drugs EHSG-KF (Primary)
  • Indications Burns
  • Focus Therapeutic Use
  • Sponsors CUTISS

    • Most Recent Events

    • 24 Feb 2025 Planned primary completion date changed from 1 Jun 2025 to 1 Jun 2026.
    • 13 Jan 2025 Number of arms changed from 1 to 2, treatment allocation changed to randomized, phase changed from phase 2/3 to phase 2, hence protocol was amended.
    • 27 Aug 2024 Planned End Date changed from 1 Dec 2025 to 1 Jun 2028.

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