NCT02731573

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

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.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: PolyPid Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

D-PLEX is a new formulation of extended controlled release Doxycycline. Subjects who meet the eligibility criteria and provide signed informed consent, will be enrolled into the study and will be treated with D-PLEX concomitantly with standard of care. D-PLEX will be administered as a single application during a cardiac surgery (index procedure) immediately prior to sternal closure, as an adjunct to the standard care. The study will assess the efficacy and safety of the controlled release antibiotic (doxycycline) by the reduction in the number of sternal infections observed during the treatment period in any subject above the age of 18 years, including patients with high risk for infection. Additional follow up for prolonged safety assessments only, will be done as follows until 24 weeks.

Conditions

• Postoperative Wound Infection Superficial Incisional
• Postoperative Wound Infection Deep Incisional Surgical Site

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-10-12
• Primary completion: 2018-02-01
• Completion: 2018-05-01
• First posted: 2016-04-07
• Last updated: 2026-04-13
• Results posted: 2026-04-13

Locations

5 sites across 1 country: Israel