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The primary objective of this study is to measure the antimicrobial effectiveness of ChloraPrep One-Step Frepp Applicator.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ChloraPrep One-Step | Drug | 1.5 ml applicator patient preoperative skin preparation | ||
| 70% isopropyl alcohol | Drug | Curity Alcohol Prep Pads |
|
| Measure | Description | Time Frame |
|---|---|---|
| Antimicrobial Efficacy | 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. | 30 seconds after treatment |
| Antimicrobial Efficacy | 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 treatment |
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Inclusion Criteria:
Exclusion Criteria:
- topical or systemic antimicrobial exposure within 14 days prior to the Screen Visit
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| Name | Affiliation | Role |
|---|---|---|
| Muhammad H Bashir, MD | Microbiotest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Microbiotest | Sterling | Virginia | 20164 | United States |
43 subjects entered screening phase.25 subjects had qualifying treatment day baseline counts and completed the study.
First subject/first visit: May 12, 2011 Last subject/last visit: June 8, 2011
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| ID | Title | Description |
|---|---|---|
| FG000 | ChloraPrep One Step and 70% Isopropyl Alcohol | All subjects received a single topical treatment with both the test article (ChloraPrep One Step) and the positive control (Isopropyl Alcohol) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | ChloraPrep One Step and 70% Isopropyl Alcohol | All subjects received a single topical treatment with both the test article (ChloraPrep One Step) and the positive control (Isopropyl Alcohol) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Antimicrobial Efficacy | 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. | subjects whose treatment day baseline microbial count met the qualification criteria and completed all assessments. | Posted | Mean | 95% Confidence Interval | log 10 colony forming units / cm^2 | 30 seconds after treatment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ChloraPrep One Step and 70% Isopropyl Alcohol | All subjects received a single topical treatment with both the test article (ChloraPrep One Step) and the positive control (Isopropyl Alcohol) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Raeder-Devens | CareFusion | 847-454-4939 | jennifer.raeder-devens@carefusion.com |
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| ID | Term |
|---|---|
| D019840 | 2-Propanol |
| ID | Term |
|---|---|
| D020005 | Propanols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Antimicrobial Efficacy | 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. | Subjects whose Treatment Day Baseline bacterial counts met qualification criteria | Posted | Mean | 95% Confidence Interval | log 10 colony forming units / cm^2 | 10 minutes after treatment |
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| 0 |
| 28 |
| 0 |
| 28 |
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| ANOVA |
| <0.05 |
| Mean Difference (Net) |
| 2.60 |
| Standard Deviation |
| 0.133 |
| 2-Sided |
| 95 |
| 2.33 |
| 2.86 |
| Superiority or Other (legacy) |