drugset / Trial / NCT02731573

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

NCT02731573

Phase 1/2 Completed 81 enrolled PolyPid Ltd.
RandomizedParallel-groupSingle-blindPrevention

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.

Timeline

Start
2016-10-12
Primary completion
2018-02
Completion
2018-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Doxycycline Small molecule

Indications

No indication recorded.