At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 2 clinical trial evaluating D-PLEX and Open heart surgery for Postoperative Wound Infection Superficial Incisional and Postoperative Wound Infection Deep Incisional Surgical Site. Completed, enrolled 81 participants across 5 sites.
Detailed 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.
Study Details
Timeline
Interventions
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.
Subject will undergo open heart surgery according to standard of care