Topical Antimicrobial Effectiveness Testing

Phase 4

Completed

• Conditions: Antimicrobial Effectiveness

• Registration Number: NCT01314703
• Lead Sponsor: CareFusion

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-10
• Study First Submitted QC: 2011-03-11
• Study First Posted: 2011-03-14
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Results First Submitted: 2012-02-08
• Results First Submitted QC: 2012-07-31
• Results First Posted: 2012-08-31
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-30
• Last Update Posted: 2012-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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.

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Exclusion Criteria

• topical or systemic antimicrobial exposure within 14 days prior to Screening Day

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.	10 minutes after single application of test material	the measure of antimicrobial efficacy was calculated by subtracting the 10 minute post test material application bacterial recovery from the baseline bacterial recovery.

Trial Locations

Locations (1)

Microbiotest; 🇺🇸 Sterling, Virginia, United States