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D-PLEX 312 - 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 II)

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Trial Profile

D-PLEX 312 - 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 II)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 16 Jun 2025

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At a glance

  • Drugs Doxycycline hyclate (Primary) ; Antibacterials; Antibacterials
  • Indications Surgical wound infections
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms D-PLEX 312; SHIELD II
  • Sponsors POLYPID

Most Recent Events

  • 10 Jun 2025 Status changed from active, no longer recruiting to completed.
  • 09 Jun 2025 According to a POLYPID media release, additional results from the SHIELD II trial will be presented at an upcoming medical conference.
  • 09 Jun 2025 Primary endpoint (To assess the anti-infective efficacy of D-PLEX over a period of 30 days post operation, by preventing surgical site infection (SSI), defined as superficial and deep infection, in the target incision(s), compared to the SoC treated control.) has been met as per POLYPID Media Release

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