drugset / Trial / NCT03633123

D-PLEX 310: Safety and Efficacy of D-PLEX in the Prevention of Post Abdominal Surgery Incisional Infection

NCT03633123

Phase 2 Completed 202 enrolled PolyPid Ltd.
RandomizedParallel-groupDouble-blindPrevention

Summary

Subjects who are planned to undergo an abdominal (colon) surgery and who will meet the study entry criteria will be randomly divided into 2 groups: for half D-PLEX will be administered concomitantly with the standard of care (SOC). The other half will receive the Standard of Care treatment. Following the surgery subjects will be followed up for additional 5 visits, at least half are in line with the routine practice of surgery Follow-Ups. Visits will include patient safety and wound assessments.

Timeline

Start
2018-10-04
Primary completion
2019-09-06
Completion
2019-10-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Doxycycline Small molecule Topical

Indications

No indication recorded.