MedTrace Logo

D-PLEX 312 - Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection (SHIELD II)

NCT04411199 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 975

Last updated 2026-07-13

Study results available
· View outcomes & findings →

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

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

Interventions

DRUG

D-PLEX

D-PLEX is a new formulation of extended release of Doxycycline.

OTHER

Standard of Care (SoC)

prophylactic, pre-operation per institution guidelines

Sponsors & Collaborators

  • PolyPid Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-12-15
Primary Completion
2025-04-14
Completion
2025-05-10
FDA Drug
Yes

Countries

  • United States
  • Bosnia and Herzegovina
  • Georgia
  • Germany
  • Hungary
  • Ireland
  • Israel
  • Moldova
  • North Macedonia
  • Poland
  • Portugal
  • Romania
  • Serbia

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 NCT04411199 on ClinicalTrials.gov