drugset / Trial / NCT04411199

D-PLEX 312 - Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection (SHIELD II)

NCT04411199

Phase 3 Completed 975 enrolled PolyPid Ltd.
RandomizedParallel-groupTriple-blindPrevention

Summary

Phase III, Prospective, Multinational, Multicenter, Randomized, Controlled, Two-arm, Double Blind Study to Assess Efficacy and Safety of D-PLEX Administered Concomitantly with the Standard of Care (SoC), Compared to a SoC Treated Control Arm, in Prevention of Post Abdominal Surgery Incisional Infection.

Timeline

Start
2020-12-15
Primary completion
2025-04-14
Completion
2025-05-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Doxycycline Small molecule Other

Indications

No indication recorded.