Topical Antimicrobial Effectiveness Testing

Phase 4

Completed

• Conditions: Antimicrobial Effectiveness

• Registration Number: NCT01366417
• Lead Sponsor: CareFusion

Brief Summary

The primary objective of this study is to measure the antimicrobial effectiveness of ChloraPrep One-Step Frepp Applicator.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Study First Submitted: 2011-06-02
• Study First Submitted QC: 2011-06-03
• Study First Posted: 2011-06-06
• Results First Submitted: 2012-02-16
• Results First Submitted QC: 2012-07-31
• Results First Posted: 2012-08-31
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-10
• Last Update Posted: 2023-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• in good general health
• have skin within 6 inches of the test sites that is free of tattoos, dermatoses, abrasions, cuts, lesions or other skin disorders.

Read More

Exclusion Criteria

• topical or systemic antimicrobial exposure within 14 days prior to the Screen Visit

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Antimicrobial Efficacy	10 minutes after treatment	Antimicrobial efficacy will be measured by the change (+/-) in bacterial count on the skin 10 minutes after a single application of test material relative to the baseline bacterial count.

Trial Locations

Locations (1)

Microbiotest; 🇺🇸 Sterling, Virginia, United States