Trial Outcomes & Findings for Effectiveness of an Antimicrobial Agent for Preoperative Skin Preparation (NCT NCT03224299)
NCT ID: NCT03224299
Last Updated: 2021-04-23
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
131 participants
Primary outcome timeframe
10 minutes
Results posted on
2021-04-23
Participant Flow
Number of participants enrolled is 131. Each participant has up to 4 sites on their body treated with assigned products. Participants are treated bilaterally on the abdomen and/or groin based on passing screening criteria.
Participant milestones
| Measure |
Number of Participants
Participants were treated with 2 of 4 study products (IP#1 \[OCT/IPA-clear\], IP#2 \[OCT/IPA-tinted\], AC \[ChloraPrep Hi-Lite Orange\], or NC \[0.9% saline\]), 1 on the left side of the body (abdomen and inguen received the same product) and 1 on the right (abdomen and inguen received the same product). Therefore, treatment groups are not discrete categories and cannot be described by treatment group.
|
Number of Sites
Test sites on body
|
|---|---|---|
|
Overall Study
STARTED
|
131
|
424
|
|
Overall Study
Treated With IP#1
|
65
|
101
|
|
Overall Study
Treated With IP#2
|
66
|
107
|
|
Overall Study
Treated With AC
|
66
|
110
|
|
Overall Study
Treated With NC
|
65
|
106
|
|
Overall Study
COMPLETED
|
131
|
424
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of an Antimicrobial Agent for Preoperative Skin Preparation
Baseline characteristics by cohort
| Measure |
Treated Subjects
n=131 Participants
All treated subjects
|
|---|---|
|
Age, Continuous
|
47 years
STANDARD_DEVIATION 17 • n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
81 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
119 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
119 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
131 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 minutesPopulation: Analysis only includes participants with required treatment day baseline bacterial counts at each anatomical site at baseline and non-missing data at 30 seconds and 10 minutes.
Outcome measures
| Measure |
Investigational Product #1
n=65 Participants
Octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - clear
|
Investigational Product #2
n=66 Participants
Octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - tinted
|
Active Control
n=66 Participants
ChloraPrep® - Hi-Lite Orange® applicator
|
Negative Control
n=65 Participants
Sterile 0.9% saline applied with single use applicator
|
|---|---|---|---|---|
|
Antimicrobial Activity of the Investigational Products Compared to Control.
Abdomen Baseline
|
3.85 log10 CFU/cm^2
Standard Deviation 0.51
|
3.91 log10 CFU/cm^2
Standard Deviation 0.52
|
3.87 log10 CFU/cm^2
Standard Deviation 0.55
|
3.84 log10 CFU/cm^2
Standard Deviation 0.55
|
|
Antimicrobial Activity of the Investigational Products Compared to Control.
Abdomen 30 seconds
|
0.98 log10 CFU/cm^2
Standard Deviation 1.31
|
1.05 log10 CFU/cm^2
Standard Deviation 1.23
|
1.34 log10 CFU/cm^2
Standard Deviation 1.24
|
3.42 log10 CFU/cm^2
Standard Deviation 0.72
|
|
Antimicrobial Activity of the Investigational Products Compared to Control.
Abdomen 10 minutes
|
1.20 log10 CFU/cm^2
Standard Deviation 1.30
|
0.91 log10 CFU/cm^2
Standard Deviation 1.15
|
1.08 log10 CFU/cm^2
Standard Deviation 1.10
|
3.12 log10 CFU/cm^2
Standard Deviation 0.87
|
|
Antimicrobial Activity of the Investigational Products Compared to Control.
Groin Baseline Groin Baseline
|
6.03 log10 CFU/cm^2
Standard Deviation 0.52
|
6.05 log10 CFU/cm^2
Standard Deviation 0.59
|
6.03 log10 CFU/cm^2
Standard Deviation 0.53
|
5.93 log10 CFU/cm^2
Standard Deviation 0.50
|
|
Antimicrobial Activity of the Investigational Products Compared to Control.
Groin 30 seconds
|
2.91 log10 CFU/cm^2
Standard Deviation 1.26
|
3.03 log10 CFU/cm^2
Standard Deviation 1.16
|
3.05 log10 CFU/cm^2
Standard Deviation 1.19
|
5.11 log10 CFU/cm^2
Standard Deviation 0.41
|
|
Antimicrobial Activity of the Investigational Products Compared to Control.
Groin 10 minutes
|
2.37 log10 CFU/cm^2
Standard Deviation 1.34
|
2.66 log10 CFU/cm^2
Standard Deviation 1.37
|
2.66 log10 CFU/cm^2
Standard Deviation 1.42
|
4.91 log10 CFU/cm^2
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: 6 hoursPopulation: Analysis only includes participants with required treatment day baseline bacterial counts at each anatomical site at baseline and non-missing data at 6 hours
Number of participants with bacterial reduction greater than or equal to baseline (0)
Outcome measures
| Measure |
Investigational Product #1
n=65 Participants
Octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - clear
|
Investigational Product #2
n=66 Participants
Octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - tinted
|
Active Control
n=66 Participants
ChloraPrep® - Hi-Lite Orange® applicator
|
Negative Control
n=65 Participants
Sterile 0.9% saline applied with single use applicator
|
|---|---|---|---|---|
|
Responder Rate at 6 Hours Post-application
Inguen
|
42 Participants
|
48 Participants
|
44 Participants
|
40 Participants
|
|
Responder Rate at 6 Hours Post-application
Abdomen
|
37 Participants
|
43 Participants
|
47 Participants
|
42 Participants
|
Adverse Events
IP#1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
IP#2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Negative Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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