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Efficacy Study to Evaluate Antimicrobial Effectiveness of ZuraPrep™ (ZX-ZP-0055)

Surgical Site Infection Clinical Trial

Official title:
A Pilot Clinical Evaluation of the Antimicrobial Effectiveness of Topically Applied ZuraPrep™

Clinical Trial Summary

This is a randomized, paired-comparisons design where each subject receives two of the planned treatments.

Clinical Trial Description

ZuraPrep is being evaluated for safety and efficacy as a preoperative skin preparation against the Tentative Final Monograph (TFM) 10-minute end point recently revised by the FDA for the lower bound of a 95% confidence interval whereas there must be specific reductions of normal flora in the abdomen and groin areas. A positive control will be evaluated as well. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02296645
Study type Interventional
Source Zurex Pharma, Inc.
Contact
Status Completed
Phase Phase 2
Start date November 2014
Completion date January 2015
View Details
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