Antimicrobial Effectiveness
Conditions
Brief summary
The primary objective of this study is to measure the antimicrobial effectiveness of ChloraPrep One-Step Frepp Applicator.
Interventions
1.5 ml applicator patient preoperative skin preparation
Curity Alcohol Prep Pads
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 90 Years
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 the Screen Visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antimicrobial Efficacy | 30 seconds after treatment | 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. |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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) | 28 |
| Total | 28 |
Baseline characteristics
| Characteristic | ChloraPrep One Step and 70% Isopropyl Alcohol |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants |
| Age, Continuous | 36 years STANDARD_DEVIATION 16.71105 |
| Region of Enrollment United States | 28 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 |
Outcome results
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.
Time frame: 30 seconds after treatment
Population: subjects whose treatment day baseline microbial count met the qualification criteria and completed all assessments.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ChloraPrep One Step | Antimicrobial Efficacy | 2.21 log 10 colony forming units / cm^2 | 95% Confidence Interval 0.1332 |
| 70% Isopropyl Alcohol | Antimicrobial Efficacy | 2.25 log 10 colony forming units / cm^2 | 95% Confidence Interval 0.1332 |
Comparison: Hypothesis: ChloraPrep will meet or exceed the 1.0 log reduction in colony forming units/cm\^2 at 30 seconds after application.p-value: <0.0595% CI: [1.95, 2.48]ANOVA
Comparison: hypothesis: 70% Isopropyl Alcohol will meet or exceed 1.0 log 10 colony forming units / cm\^2 at 30 seconds after treatmentp-value: <0.0595% CI: [1.99, 2.51]ANOVA
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.
Time frame: 10 minutes after treatment
Population: Subjects whose Treatment Day Baseline bacterial counts met qualification criteria
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ChloraPrep One Step | Antimicrobial Efficacy | 2.65 log 10 colony forming units / cm^2 |
| 70% Isopropyl Alcohol | Antimicrobial Efficacy | 2.60 log 10 colony forming units / cm^2 |
Comparison: Hypothesis: ChloraPrep One Step will meet or exceed 2.0 log 10 reduction at 10 minutes after treatment.p-value: <0.0595% CI: [2.39, 2.91]ANOVA
Comparison: Hypothesis: 70% Isopropyl Alcohol will meet or exceed 2.0 log 10 reduction at 10 minutes after treatmentp-value: <0.0595% CI: [2.33, 2.86]ANOVA