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COMPLETED
NCT02731573
PHASE1/PHASE2

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

Sponsor: PolyPid Ltd.

View on ClinicalTrials.gov

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.

Official title: A Phase Ib/II Prospective, Multicenter, Two Part Study; Part 1 - Open Label, Single Arm & Part 2 Randomized, Single-blinded Study to Assess Safety and Efficacy of D-PLEX Concomitantly With Standard of Care vs. Standard of Care Alone in the Prevention of Sternal Infection Post Cardiac Surgery.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

81

Start Date

2016-10-12

Completion Date

2018-05

Last Updated

2026-04-13

Healthy Volunteers

No

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

Locations (5)

Soroka Medical Center

Beersheba, Israel

Rambam Medical Center

Haifa, Israel

Assuta Medical Center

Tel Aviv, Israel

Sheba Medical Center

Tel Litwinsky, Israel

Poriya Medical Center

Tiberias, Israel