Antimicrobial Effectiveness
Conditions
Brief summary
The primary objective of this study is to measure the antimicrobial effectiveness of ChloraPrep one-Step.
Interventions
10.5 ml applicator preoperative skin preparation
10.5 ml applicator
Sponsors
C. R. Bard
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | 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. | 10 minutes after single application of test material | the measure of antimicrobial efficacy was calculated by subtracting the 10 minute post test material application bacterial recovery from the baseline bacterial recovery. |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Group 1 All subjects received treatment with both the test article and the positive control | 27 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | screen failure and closed enrollment | 8 |
Baseline characteristics
| Characteristic | Group 1 |
|---|---|
| Age, Continuous | 35 years STANDARD_DEVIATION 12.7 |
| Region of Enrollment United States | 27 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 27 |
| serious Total, serious adverse events | 0 / 27 |
Outcome results
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.
Time frame: 10 minutes after single application of test material
Population: 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 | Measure | Group | Value (MEAN) |
|---|---|---|---|
| ChloraPrep One Step, 10.5 mL Applicator | 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 minute abdomen | 2.8469 log 10 colony forming units |
| ChloraPrep One Step, 10.5 mL Applicator | 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 minute groin | 4.038 log 10 colony forming units |
| 70% Isopropyl Alcohol, 10.5 mL Applicator | 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 minute abdomen | 2.5328 log 10 colony forming units |
| 70% Isopropyl Alcohol, 10.5 mL Applicator | 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 minute groin | 3.5295 log 10 colony forming units |
Comparison: 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).95% CI: [2.66, 3.02]ANOVA
Comparison: 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).95% CI: [3.74, 4.33]ANOVA
Comparison: 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).95% CI: [2.36, 2.7]ANOVA
Comparison: 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).95% CI: [3.24, 3.82]ANOVA