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Topical Antimicrobial Effectiveness Testing

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ClinicalTrials.gov Identifier: NCT01366417
Recruitment Status : Completed
First Posted : June 6, 2011
Results First Posted : August 31, 2012
Last Update Posted : September 10, 2012
Sponsor:
Information provided by (Responsible Party):
CareFusion

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: Single (Outcomes Assessor)
Condition Antimicrobial Effectiveness
Interventions Drug: ChloraPrep One-Step
Drug: 70% isopropyl alcohol
Enrollment 25
Recruitment Details First subject/first visit: May 12, 2011 Last subject/last visit: June 8, 2011
Pre-assignment Details 43 subjects entered screening phase.25 subjects had qualifying treatment day baseline counts and completed the study.
Arm/Group Title ChloraPrep One Step and 70% Isopropyl Alcohol
Hide Arm/Group Description All subjects received a single topical treatment with both the test article (ChloraPrep One Step) and the positive control (Isopropyl Alcohol)
Period Title: Overall Study
Started 43
Signed Informed Consent 43 [1]
Completed Screen Visit 33 [2]
Completed Treatment Visit 28 [3]
Completed the Study 28 [4]
Discontinued Prior to Treatment 5 [5]
Excluded From Analysis 3 [6]
Completed 25 [7]
Not Completed 18
[1]
Microbial samples were taken from 43 subjects for screening baseline.
[2]
33 subjects had qualifying screening bacterial counts and were eligible for the Treatment Visit
[3]
28 subjects were treated with ChloraPrep and 70% Isopropyl Alcohol (single topical treatment)
[4]
treatment baseline microbial counts not available until after treatment; subjects not evaluable
[5]
5 eligible subjects were not treated because enrollment target of 25 was met and enrollment closed.
[6]
3 subjects did not have qualifying Treatment Day microbial counts and were excluded from analysis
[7]
25 subjects included in the analysis
Arm/Group Title ChloraPrep One Step and 70% Isopropyl Alcohol
Hide Arm/Group Description All subjects received a single topical treatment with both the test article (ChloraPrep One Step) and the positive control (Isopropyl Alcohol)
Overall Number of Baseline Participants 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
<=18 years
0
   0.0%
Between 18 and 65 years
28
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants
36  (16.71105)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Female
16
  57.1%
Male
12
  42.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants
28
1.Primary Outcome
Title Antimicrobial Efficacy
Hide Description Antimicrobial efficacy will be measured by the change (+/-) in bacterial count on the skin 30 seconds after a single application of test material relative to the baseline bacterial count.
Time Frame 30 seconds after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
subjects whose treatment day baseline microbial count met the qualification criteria and completed all assessments.
Arm/Group Title ChloraPrep One Step 70% Isopropyl Alcohol
Hide Arm/Group Description:
All subjects received a single topical application of ChloraPrep One Step.
All subjects received a single topical application of 70% Isopropyl Alcohol.
Overall Number of Participants Analyzed 25 25
Mean (95% Confidence Interval)
Unit of Measure: log 10 colony forming units / cm^2
2.21
(1.95 to 2.48)
2.25
(1.99 to 2.51)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ChloraPrep One Step
Comments Hypothesis: ChloraPrep will meet or exceed the 1.0 log reduction in colony forming units/cm^2 at 30 seconds after application.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.21
Confidence Interval (2-Sided) 95%
1.95 to 2.48
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.133
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 70% Isopropyl Alcohol
Comments hypothesis: 70% Isopropyl Alcohol will meet or exceed 1.0 log 10 colony forming units / cm^2 at 30 seconds after treatment
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.25
Confidence Interval (2-Sided) 95%
1.99 to 2.51
Parameter Dispersion
Type: Standard Deviation
Value: 0.133
Estimation Comments [Not Specified]
2.Primary Outcome
Title Antimicrobial Efficacy
Hide Description 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.
Time Frame 10 minutes after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects whose Treatment Day Baseline bacterial counts met qualification criteria
Arm/Group Title ChloraPrep One Step 70% Isopropyl Alcohol
Hide Arm/Group Description:
All subjects received a single topical application of ChloraPrep One Step.
All subjects received a single topical application of 70% Isopropyl Alcohol.
Overall Number of Participants Analyzed 25 25
Mean (95% Confidence Interval)
Unit of Measure: log 10 colony forming units / cm^2
2.65
(2.39 to 2.92)
2.60
(2.33 to 2.86)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ChloraPrep One Step
Comments Hypothesis: ChloraPrep One Step will meet or exceed 2.0 log 10 reduction at 10 minutes after treatment.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.65
Confidence Interval (2-Sided) 95%
2.39 to 2.91
Parameter Dispersion
Type: Standard Deviation
Value: 0.133
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 70% Isopropyl Alcohol
Comments Hypothesis: 70% Isopropyl Alcohol will meet or exceed 2.0 log 10 reduction at 10 minutes after treatment
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.60
Confidence Interval (2-Sided) 95%
2.33 to 2.86
Parameter Dispersion
Type: Standard Deviation
Value: 0.133
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ChloraPrep One Step and 70% Isopropyl Alcohol
Hide Arm/Group Description All subjects received a single topical treatment with both the test article (ChloraPrep One Step) and the positive control (Isopropyl Alcohol)
All-Cause Mortality
ChloraPrep One Step and 70% Isopropyl Alcohol
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ChloraPrep One Step and 70% Isopropyl Alcohol
Affected / at Risk (%)
Total   0/28 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ChloraPrep One Step and 70% Isopropyl Alcohol
Affected / at Risk (%)
Total   0/28 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Jennifer Raeder-Devens
Organization: CareFusion
Phone: 847-454-4939
Responsible Party: CareFusion
ClinicalTrials.gov Identifier: NCT01366417     History of Changes
Other Study ID Numbers: 371.1.04.19.11
First Submitted: June 2, 2011
First Posted: June 6, 2011
Results First Submitted: February 16, 2012
Results First Posted: August 31, 2012
Last Update Posted: September 10, 2012