In-vivo Efficacy of Patient Preoperative Prep, ZuraPrep (ZP)

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2019
The primary objective of this study is to measure the antimicrobial effectiveness of a single investigational test article, ZuraPrep™ as specified by the Healthcare Antiseptics, Topical Antimicrobial Drug Products Final Rule of December 20, 2017. The treatments will be ZuraPrep™ as the investigational test article, ChloraPrep® as an active control, and ZuraPrep™ Vehicle as a negative control. For efficacy at 30 seconds post‐prep, the test article should be superior to the negative control using a margin of 1.2 log10 CFU/cm2 and non‐inferior to the active control using a margin of 0.5 log10 CFU/cm2.
Epistemonikos ID: 6b3d036af06761c157fcf37330caf8000422ab20
First added on: May 21, 2024