CompletedPhase 1/2

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

Israel81 participantsStarted 2016-10-12

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or non-pregnant female above 18 years old
✓. Female of childbearing potential should have a negative serum pregnancy test prior to index procedure.
✓. Subjects undergoing elective or urgent cardiac surgery, who are preoperative stable hemodynamically.
✓. Subjects with (20≤BMI≤40)
✓. Subjects who sign a written informed consent.

Exclusion criteria

✕. Received any investigational drug within 30 days of start of study or within 5½ half-lives (pharmacokinetic or pharmacodynamics) prior to enrollment (whichever is longer).
✕. Are ineligible to receive treatment with:
✕. Pregnant or breastfeeding women.
✕. Subjects who have taken oral or IV doxycycline during the last 4 weeks prior to screening.
✕. Subjects who undergo cardiac/open chest surgeries, which are classified as emergency.
✕. Immunocompromised subjects from any reason, at screening.
✕. Subjects that undergone TIA/ CVA within the last 3 months prior to enrollment.
✕. Subjects that previously underwent any cardiac surgery through mid-sternum.

What they're measuring

Decrease of Infection Rate as Measured by the Proportion of Subjects With at Least 1 Identified Sternal Infection Within 90 Days Post-cardiac Surgery.

Timeframe: Within 90 days post-cardiac surgery.

Trial details

NCT IDNCT02731573

SponsorPolyPid Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-02

Results submitted2026-01-07

View on ClinicalTrials.gov More Postoperative Wound Infection Superficial Incisional trials