Clinical Evaluation of Patient Preoperative Prep

Phase 3 Completed 640 enrolled Zurex Pharma, Inc.

RandomizedParallel-groupSingle-blindPrevention

Summary

The objective of the study is to demonstrate the antimicrobial efficacy of the ZP Preoperative Prep on skin flora of the abdomen and inguinal regions of human subjects.

Timeline

Start: 2016-08-03
Primary completion: 2017-08-03
Completion: 2017-08-03

Publications

Edmiston CE, Lavin P, Spencer M, Borlaug G, Seabrook GR, Leaper D. Antiseptic efficacy of an innovative perioperative surgical skin preparation: A confirmatory FDA phase 3 analysis. Infect Control Hosp Epidemiol. 2020 Jun;41(6):653-659. doi: 10.1017/ice.2020.27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Chlorhexidine	Small molecule	2 %	Topical
Comparator	Chlorhexidine	Small molecule	70 %	Topical
Subject	ZuraPrep	Unknown	2 %	Topical
Subject	ZuraPrep	Unknown	70 %	Topical

Indications

No indication recorded.