Clinical trial
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.
NCT02731573 is registered in ClinicalTrials.gov with PolyPid Ltd. as lead sponsor.
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Registry record
As filed in ClinicalTrials.gov.
- 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.
- Lead sponsor
- PolyPid Ltd.
- Phase
- Phase 1/2
- Overall status
- Completed
- Start date
- October 12, 2016
- Completion date
- May 31, 2018
- Enrollment
- 81 (actual)
- Sites
- 5
Conditions
As the registry lists them; a condition with its own page is linked.
postoperative wound infection deep incisional surgical site, postoperative wound infection superficial incisional