Trial | NCT01314703  Report issue

Title

Topical Antimicrobial Effectiveness Testing
Test for Preoperative Skin Preparations

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Study Participants

    27
The primary objective of this study is to measure the antimicrobial effectiveness of ChloraPrep one-Step.
Study Started
Mar 31
2011
Primary Completion
Apr 30
2011
Study Completion
Apr 30
2011
Results Posted
Aug 31
2012
Estimate
Last Update
Nov 01
2012
Estimate

Drug ChloraPrep One-Step

10.5 ml applicator preoperative skin preparation

Drug 70% isopropyl alcohol

10.5 ml applicator

  • Other names: Positive control

Criteria 

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.

Exclusion Criteria:

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

Summary

Group 1

All Events

Event Type Organ System Event Term

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.

the measure of antimicrobial efficacy was calculated by subtracting the 10 minute post test material application bacterial recovery from the baseline bacterial recovery.

ChloraPrep One Step, 10.5 mL Applicator

10 minute abdomen

2.8469
log 10 colony forming units (Mean)
95% Confidence Interval: 2.6699 to 3.0238

10 minute groin

4.038
log 10 colony forming units (Mean)
95% Confidence Interval: 3.7438 to 4.3322

70% Isopropyl Alcohol, 10.5 mL Applicator

10 minute abdomen

2.5328
log 10 colony forming units (Mean)
95% Confidence Interval: 2.3559 to 2.7097

10 minute groin

3.5295
log 10 colony forming units (Mean)
95% Confidence Interval: 3.2353 to 3.8237

Age Continuous

35
years (Mean)
Standard Deviation: 12.7

Region of Enrollment

Sex: Female, Male

Overall Study

ChloraPrep and 70% Isopropyl Alcohol

Drop/Withdrawal Reasons

ChloraPrep and 70% Isopropyl Alcohol