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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

October 31, 2016

Primary Completion Date

February 28, 2018

Study Completion Date

May 31, 2018

Conditions
Postoperative Wound Infection Superficial IncisionalPostoperative 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

Trial Locations (5)

Unknown

Soroka Medical Center, Beersheba

Rambam Medical Center, Haifa

Assuta Medical Center, Tel Aviv

Sheba Medical Center, Tel Litwinsky

Poriya Medical Center, Tiberias

Sponsors

Lead Sponsor

All Listed Sponsors
lead

PolyPid Ltd.

INDUSTRY