NCT03782103

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

Clinical Evaluation of the Antimicrobial Effectiveness of Topically Applied ZuraPrep

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: Zurex Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of the study is to demonstrate the antimicrobial efficacy of the Zurex Preoperative Prep (ZuraPrep - clear) on skin flora of the abdomen and inguinal regions of human subjects.

Detailed description

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.

Conditions

• Surgical Skin Preparation

Interventions

Type	Name	Description
DRUG	ZuraPrep Clear Solution	Apply topically.
DRUG	ChloraPrep	Apply topically.
DRUG	ZuraPrep Vehicle	Apply topically.

Timeline

• Start date: 2019-01-25
• Primary completion: 2019-05-12
• Completion: 2019-09-26
• First posted: 2018-12-20
• Last updated: 2023-02-08
• Results posted: 2022-07-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study