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Safety and Efficacy of D-PLEX in the Prevention of Sternal Infection Post Cardiac Surgery.

NCT02731573 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2026-04-13

Study results available
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Summary

This study is aimed to assess the anti-infective efficacy of D-PLEX over a period of 3 months post operation as well as the safety over a period of 6 months, by preventing sternal infection post cardiac surgery in patients above the age of 18, including high risk patients for infection. This study is a 2 parts study: part 1 is a single arm, part 2 is randomized controlled study.

Conditions

  • Postoperative Wound Infection Superficial Incisional
  • Postoperative Wound Infection Deep Incisional Surgical Site

Interventions

DRUG

D-PLEX

D-PLEX will be administered as a single application during the open heart surgery (index procedure) immediately prior to sternal closure, as an adjunct to the standard care.

PROCEDURE

Open heart surgery

Subject will undergo open heart surgery according to standard of care

Sponsors & Collaborators

  • PolyPid Ltd.

    lead INDUSTRY

Principal Investigators

  • Erez V. Kachel, MD · Sheba MC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-12
Primary Completion
2018-02-28
Completion
2018-05-31

Countries

  • Israel

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 NCT02731573 on ClinicalTrials.gov