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D-PLEX 311- Phase III, Prospective, Multinational, Multicenter, Randomized, Controlled, Two-arm, Double Blind Study to Assess Efficacy and Safety of D-PLEX In Prevention of Post Abdominal Surgery Incisional Infection(SHIELD I)

Trial Profile

D-PLEX 311- Phase III, Prospective, Multinational, Multicenter, Randomized, Controlled, Two-arm, Double Blind Study to Assess Efficacy and Safety of D-PLEX In Prevention of Post Abdominal Surgery Incisional Infection(SHIELD I)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Oct 2024

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At a glance

  • Drugs Doxycycline hyclate (Primary) ; Antibacterials
  • Indications Surgical wound infections
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms SHIELD I
  • Sponsors POLYPID
  • Most Recent Events

    • 21 Oct 2024 According to a POLYPID media release, today announced a publication in the International Journal of Surgery (IJS), the article highlights the full dataset from the first Phase 3 study of D-PLEX100, from which top-line results were announced in September 2022.
    • 09 Oct 2023 According to a POLYPID media release, data from this study will be presented at the American College of Surgeons Clinical Congress 2023.
    • 12 Dec 2022 According to POLYPID media release, the company provided the FDA with currently available data from this study.

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