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Topical Antimicrobial Effectiveness Testing

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ClinicalTrials.gov Identifier: NCT01314703
Recruitment Status : Completed
First Posted : March 14, 2011
Results First Posted : August 31, 2012
Last Update Posted : November 1, 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 27
Recruitment Details Recruitment period: March 05-April 04, 2011. Location: Microbiotest,clinical study center
Pre-assignment Details 35 subjects entered pre-screening phase.2 subjects withdrew consent prior to the Screen Visit.33 subjects completed screen baseline.3 subjects did not meet screen baseline criteria.30 subjects qualified for treatment.3 subjects were discontinued prior to treatment because the required number of treatment sites were met. 27 subjects were treated.
Arm/Group Title ChloraPrep and 70% Isopropyl Alcohol
Hide Arm/Group Description All subjects received treatment with both the ChloraPrep and 70% Isopropyl Alcohol
Period Title: Overall Study
Started 35
Signed Informed Consent 35
Completed Screen Visit 33
Completed Treatment Visit 27
Completed Study 27
Excluded Prior to Screening Baseline 2
Non Qualified Bacterial Screening Counts 3
Discontinued When Enrollment Completed 3
Completed 27
Not Completed 8
Reason Not Completed
screen failure and closed enrollment             8
Arm/Group Title Group 1
Hide Arm/Group Description All subjects received treatment with both the test article and the positive control
Overall Number of Baseline Participants 27
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants
35  (12.7)
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants
35  (12.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants
Female
9
  33.3%
Male
18
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants
27
1.Primary Outcome
Title 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.
Hide Description the measure of antimicrobial efficacy was calculated by subtracting the 10 minute post test material application bacterial recovery from the baseline bacterial recovery.
Time Frame 10 minutes after single application of test material
Hide Outcome Measure Data
Hide Analysis Population Description
27 subjects were treated with ChloraPrep on the abdomen and groin treatment sites. 26 of the 27 abdomen sites met the qualifying bacterial baseline count and were included in the analysis. 25 of the groin sites met the qualifying bacterial baseline count and were included in the analysis.
Arm/Group Title ChloraPrep One Step, 10.5 mL Applicator 70% Isopropyl Alcohol, 10.5 mL Applicator
Hide Arm/Group Description:
All subjects received single application of treatment with ChloraPrep One Step 10.5 mL Applicator on two treatment sites (abdomen and groin).
All subjects received single application of treatment with 70% Isopropyl Alcohol 10.5 mL Applicator on two treatment sites (abdomen and groin).
Overall Number of Participants Analyzed 27 27
Mean (95% Confidence Interval)
Unit of Measure: log 10 colony forming units
10 minute abdomen
2.8469
(2.6699 to 3.0238)
2.5328
(2.3559 to 2.7097)
10 minute groin
4.038
(3.7438 to 4.3322)
3.5295
(3.2353 to 3.8237)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ChloraPrep One Step, 10.5 mL Applicator
Comments Hypothesis: ChloraPrep will exceed 3 log 10 reduction for the groin at 10 minutes and 2 log 10 reduction for the abdomen at 10 minutes. The 70% Isopropyl Alcohol was used as a positive control. All calculations were performed after taking the base-10 logarithm of the original values. The model was a mixed model Analysis of Variance (ANOVA).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.85
Confidence Interval (2-Sided) 95%
2.66 to 3.02
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.089
Estimation Comments ChloraPrep 10 minute abdomen
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection ChloraPrep One Step, 10.5 mL Applicator
Comments Hypothesis: ChloraPrep will exceed 3 log 10 reduction for the groin at 10 minutes and 2 log 10 reduction for the abdomen at 10 minutes. The 70% Isopropyl Alcohol was used as a positive control. All calculations were performed after taking the base-10 logarithm of the original values. The model was a mixed model Analysis of Variance (ANOVA).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 4.038
Confidence Interval (2-Sided) 95%
3.74 to 4.33
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.149
Estimation Comments ChloraPrep 10 minute groin
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 70% Isopropyl Alcohol, 10.5 mL Applicator
Comments Hypothesis: ChloraPrep will exceed 3 log 10 reduction for the groin at 10 minutes and 2 log 10 reduction for the abdomen at 10 minutes. The 70% Isopropyl Alcohol was used as a positive control. All calculations were performed after taking the base-10 logarithm of the original values. The model was a mixed model Analysis of Variance (ANOVA).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.53
Confidence Interval (2-Sided) 95%
2.36 to 2.70
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.089
Estimation Comments 70%Isopropyl Alcohol 10 minute abdomen
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection 70% Isopropyl Alcohol, 10.5 mL Applicator
Comments Hypothesis: ChloraPrep will exceed 3 log 10 reduction for the groin at 10 minutes and 2 log 10 reduction for the abdomen at 10 minutes. The 70% Isopropyl Alcohol was used as a positive control. All calculations were performed after taking the base-10 logarithm of the original values. The model was a mixed model Analysis of Variance (ANOVA).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 3.53
Confidence Interval (2-Sided) 95%
3.24 to 3.82
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.149
Estimation Comments 70% Isopropyl Alcohol 10 minute groin
Time Frame Study duration was approximately 21 days per study participant. Overall study duration was 28 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1
Hide Arm/Group Description All subjects received treatment with both the test article and the positive control
All-Cause Mortality
Group 1
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group 1
Affected / at Risk (%)
Total   0/27 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group 1
Affected / at Risk (%)
Total   0/27 (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: NCT01314703     History of Changes
Other Study ID Numbers: 371.1.02.15.11
First Submitted: March 10, 2011
First Posted: March 14, 2011
Results First Submitted: February 8, 2012
Results First Posted: August 31, 2012
Last Update Posted: November 1, 2012