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D-PLEX 311: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection

NCT04233424 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 977

Last updated 2026-04-21

Study results available
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Summary

Phase III, Prospective, Multinational, Multicenter, Randomized, Controlled, Two-arm, Double Blind Study to assess Efficacy and Safety of D-PLEX Administered Concomitantly with the Standard of Care (SoC), compared to a SoC treated control arm, in prevention of post abdominal surgery incisional infection.

Conditions

  • Abdominal Surgery
  • Surgical Site Infection
  • Colon Surgery
  • Post-Op Infection

Interventions

DRUG

D-PLEX

D-PLEX is a new formulation of extended release of Doxycycline. Each 5g D-PLEX vial contains 54.6mg Doxycycline free base (1.09%), which is equivalent to 63mg Doxycycline hyclate (1.26%). D-PLEX is supplied as a sterile powder to be reconstituted to paste in the operating room, using standard aseptic techniques and is intended for single administration. The non-active components of the extended release antibiotic formulation are β Tri-Calcium polymer and a lipid matrix. All formulation components are biodegradable.

DRUG

Standard of Care (SoC)

prophylactic, pre-operation per institution guidelines

Sponsors & Collaborators

  • PolyPid Ltd.

    lead INDUSTRY

Principal Investigators

  • Shmuel Sharoni, MD · PolyPid Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-24
Primary Completion
2022-09-02
Completion
2022-09-02
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Croatia
  • Czechia
  • Hungary
  • Israel
  • Moldova
  • Poland
  • Romania
  • Slovakia

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 NCT04233424 on ClinicalTrials.gov