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Safety and Efficacy of D-PLEX in the Prevention of Sternal Infection Post Cardiac Surgery.
Sponsor: PolyPid Ltd.
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
Conditions
Interventions
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.
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