D-PLEX 302: Efficacy and Safety of D-PLEX in the Prevention of Sternal Infection Post Cardiac Surgery
Trial details
- Registry ID
- NCT03558984
- Phase
- Phase 3
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Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.
| Trial | Sponsor | Phase | Status | Primary completion |
|---|---|---|---|---|
| D-PLEX 302: Efficacy and Safety of D-PLEX in the Prevention of Sternal Infection Post Cardiac SurgeryNCT03558984 | PYPD | Phase 3 | Terminated | 2022-10-24Actual |
| D-PLEX 310: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional InfectionNCT03633123 | PYPD | Phase 2 | Completed | 2019-09-06Actual |
| D-PLEX 311: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional InfectionNCT04233424 | PYPD | Phase 3 | Completed | 2022-09-02Actual |
| D-PLEX 312 - Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection (SHIELD II)NCT04411199 | PYPD | Phase 3 | Completed | 2025-04-14Actual |
NCT04411199 · PolyPid Ltd.
Text changed; whether the study measures changed has not been verified. Saved text may be shortened.
Measure: Infection Rate as Measured by the Proportion of Subjects With an Surgical Site Infection (SSI) Event in the Population of Subjects With Target Incision Length >20 cm
Measure: Infection Rate as Measured by the Percentage of Subjects With SSI Event in the Target Incision Within 30 Days Post Index Surgery or Re-interventions or Death [for Any Reason] in the Population of Subjects With Target Incision Length >20 cm
NCT03558984 · PolyPid Ltd.
Text changed; whether the study measures changed has not been verified. Saved text may be shortened.
Measure: Proportion of Participants With a Sternal Wound Infection Event
Measure: Number of Participants With a Sternal Wound Infection Event
NCT04411199 · PolyPid Ltd.
Text changed; whether the study measures changed has not been verified. Saved text may be shortened.
Measure: To assess the anti-infective efficacy of D-PLEX over a period of 30 days post operation, by preventing surgical site infection (SSI), defined as superficial and deep infection, in the target incision(s), compared to the SoC treated control.
Measure: Safety of D-PLEX in Prevention of Post Abdominal Surgery
Measure: Safety of D-PLEX in Prevention of Post Abdominal Surgery Incisional
Measure: Infection Rate as Measured by the Proportion of Subjects With an Surgical Site Infection (SSI) Event in the Population of Subjects With Target Incision Length >20 cm
800 participants (actual)
975 participants (actual)
NCT03558984 · PolyPid Ltd.
Text changed; whether the study measures changed has not been verified. Saved text may be shortened.
Measure: Sternal Wound Infection (SWI) Rate
Measure: Proportion of Participants With a Sternal Wound Infection Event
NCT03558984 · PolyPid Ltd.
Text changed; whether the study measures changed has not been verified. Saved text may be shortened.
Measure: Sternal Wound Infection Rate
Measure: Sternal Wound Infection (SWI) Rate
NCT03633123 · PolyPid Ltd.
Text changed; whether the study measures changed has not been verified. Saved text may be shortened.
Measure: Infection rate as measured by the proportion of subjects with abdominal incisional infection event
Measure: The Combined Infection and Mortality Rate Within 30 Days Post Index Surgery
200 participants (actual)
202 participants (actual)
NCT03558984 · PolyPid Ltd.
Text changed; whether the study measures changed has not been verified. Saved text may be shortened.
Measure: Sternal Wound Infection rate
Measure: Sternal Wound Infection Rate