Trial Outcomes & Findings for Topical Antimicrobial Effectiveness Testing (NCT NCT01314703)
NCT ID: NCT01314703
Last Updated: 2012-11-01
Results Overview
the measure of antimicrobial efficacy was calculated by subtracting the 10 minute post test material application bacterial recovery from the baseline bacterial recovery.
COMPLETED
PHASE4
27 participants
10 minutes after single application of test material
2012-11-01
Participant Flow
Recruitment period: March 05-April 04, 2011. Location: Microbiotest,clinical study center
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.
Participant milestones
| Measure |
ChloraPrep and 70% Isopropyl Alcohol
All subjects received treatment with both the ChloraPrep and 70% Isopropyl Alcohol
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
Signed Informed Consent
|
35
|
|
Overall Study
Completed Screen Visit
|
33
|
|
Overall Study
Completed Treatment Visit
|
27
|
|
Overall Study
Completed Study
|
27
|
|
Overall Study
Excluded Prior to Screening Baseline
|
2
|
|
Overall Study
Non Qualified Bacterial Screening Counts
|
3
|
|
Overall Study
Discontinued When Enrollment Completed
|
3
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
ChloraPrep and 70% Isopropyl Alcohol
All subjects received treatment with both the ChloraPrep and 70% Isopropyl Alcohol
|
|---|---|
|
Overall Study
screen failure and closed enrollment
|
8
|
Baseline Characteristics
Topical Antimicrobial Effectiveness Testing
Baseline characteristics by cohort
| Measure |
Group 1
n=27 Participants
All subjects received treatment with both the test article and the positive control
|
|---|---|
|
Age Continuous
|
35 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 minutes after single application of test materialPopulation: 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.
the measure of antimicrobial efficacy was calculated by subtracting the 10 minute post test material application bacterial recovery from the baseline bacterial recovery.
Outcome measures
| Measure |
ChloraPrep One Step, 10.5 mL Applicator
n=27 Participants
All subjects received single application of treatment with ChloraPrep One Step 10.5 mL Applicator on two treatment sites (abdomen and groin).
|
70% Isopropyl Alcohol, 10.5 mL Applicator
n=27 Participants
All subjects received single application of treatment with 70% Isopropyl Alcohol 10.5 mL Applicator on two treatment sites (abdomen and groin).
|
|---|---|---|
|
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
Interval 2.6699 to 3.0238
|
2.5328 log 10 colony forming units
Interval 2.3559 to 2.7097
|
|
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
Interval 3.7438 to 4.3322
|
3.5295 log 10 colony forming units
Interval 3.2353 to 3.8237
|
Adverse Events
Group 1
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place