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The primary objective of this study is to measure the antimicrobial effectiveness of ChloraPrep one-Step.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ChloraPrep One-Step | Drug | 10.5 ml applicator preoperative skin preparation | ||
| 70% isopropyl alcohol | Drug | 10.5 ml applicator |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 minutes after single application of test material |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
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.
Recruitment period: March 05-April 04, 2011. Location: Microbiotest,clinical study center
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| ID | Title | Description |
|---|---|---|
| FG000 | ChloraPrep and 70% Isopropyl Alcohol | All subjects received treatment with both the ChloraPrep and 70% Isopropyl Alcohol |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | All subjects received treatment with both the test article and the positive control |
| 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, Continuous | Mean |
| 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 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. | 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. | Posted | Jun 2011 | Mean | 95% Confidence Interval | log 10 colony forming units | 10 minutes after single application of test material |
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Study duration was approximately 21 days per study participant. Overall study duration was 28 days.
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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 | Group 1 | All subjects received treatment with both the test article and the positive control |
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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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| years |
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| 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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| OG001 | 70% Isopropyl Alcohol, 10.5 mL Applicator | All subjects received single application of treatment with 70% Isopropyl Alcohol 10.5 mL Applicator on two treatment sites (abdomen and groin). |
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| 0 |
| 27 |
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| 27 |
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