Trial Outcomes & Findings for In Vivo Preoperative Skin Preparation Persistence Evaluation (NCT NCT03155178)
NCT ID: NCT03155178
Last Updated: 2024-10-02
Results Overview
The primary measure of persistence is the suppression of regrowth recovery relative to baseline (log10 CFU/cm\^2) of skin flora at 3 defined post-treatment sampling times.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
69 participants
Primary outcome timeframe
Baseline, 48-hours post-treatment, 72-hours post-treatment and 96-hours post-treatment
Results posted on
2024-10-02
Participant Flow
This is a randomized, paired-comparisons design where each subject will receive two of the planned treatments, one on the left side of body and one on the right. Each subject provides 2 abdomen test sites, left or right, and 2 inguen test sites, left or right. Therefore 69 subjects provide 276 potential test sites.
Unit of analysis: test sites on skin
Participant milestones
| Measure |
3M CHG/IPA Prep/Abdominal Region
Experimental CHG/IPA prep was randomly assigned to the left or right side of the abdominal test site
|
ChloraPrep/Abdominal Region
Active comparator CHG/IPA prep was randomly assigned to the left or right side of the abdominal test sites
|
3M CHG/IPA Prep/Inguinal Region
Experimental CHG/IPA prep was randomly assigned to the left or right side of the inguinal test site
|
ChloraPrep/Inguinal Region
Active comparator prep was randomly assigned to the left or right side of the inguinal test site
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
69 69
|
69 69
|
69 69
|
69 69
|
|
Overall Study
COMPLETED
|
62 62
|
62 62
|
62 62
|
62 62
|
|
Overall Study
NOT COMPLETED
|
7 7
|
7 7
|
7 7
|
7 7
|
Reasons for withdrawal
| Measure |
3M CHG/IPA Prep/Abdominal Region
Experimental CHG/IPA prep was randomly assigned to the left or right side of the abdominal test site
|
ChloraPrep/Abdominal Region
Active comparator CHG/IPA prep was randomly assigned to the left or right side of the abdominal test sites
|
3M CHG/IPA Prep/Inguinal Region
Experimental CHG/IPA prep was randomly assigned to the left or right side of the inguinal test site
|
ChloraPrep/Inguinal Region
Active comparator prep was randomly assigned to the left or right side of the inguinal test site
|
|---|---|---|---|---|
|
Overall Study
Did not meet treatment day baseline
|
7
|
7
|
7
|
7
|
Baseline Characteristics
In Vivo Preoperative Skin Preparation Persistence Evaluation
Baseline characteristics by cohort
| Measure |
3M CHG/IPA/Abdominal Region
n=69 test sites on skin
Investigational CHG/IPA Prep randomly assigned to the left or right abdominal region test sites
|
ChloraPrep/Abdominal Region
n=69 test sites on skin
Active marketed comparator CHG/IPA Prep randomly assigned to the left or right abdominal region test sites
|
3M CHG/IPA/Inguinal Region
n=69 test sites on skin
Investigational CHG/IPA Prep randomly assigned to the left or right inguiinal region test sites
|
ChloraPrep/Inguinal Region
n=69 test sites on skin
Active marketed comparator CHG/IPA Prep randomly assigned to the left or right abdominal region test sites
|
Total
n=276 test sites on skin
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
62 Participants
n=99 Participants
|
62 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
62 Participants
n=7 Participants
|
248 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
28 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
48 Participants
n=7 Participants
|
192 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
21 Participants
n=7 Participants
|
84 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
69 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
69 Participants
n=206 Participants
|
69 Participants
n=7 Participants
|
276 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
69 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
69 Participants
n=206 Participants
|
69 Participants
n=7 Participants
|
276 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Subjects meeting treatment day baseline requirement
|
69 test sites on skin
n=343 test sites on skin
|
69 test sites on skin
n=344 test sites on skin
|
69 test sites on skin
n=347 test sites on skin
|
69 test sites on skin
n=104 test sites on skin
|
276 test sites on skin
n=242 test sites on skin
|
PRIMARY outcome
Timeframe: Baseline, 48-hours post-treatment, 72-hours post-treatment and 96-hours post-treatmentPopulation: The primary analysis data set used a Modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of either \> or equal to 3.0 log10 CFU/cm\^2 on the abdomen test site or \> or equal to 5.0 log10 CFU/cm\^2 on the inguinal test site.
The primary measure of persistence is the suppression of regrowth recovery relative to baseline (log10 CFU/cm\^2) of skin flora at 3 defined post-treatment sampling times.
Outcome measures
| Measure |
Active Comparator Prep - Abdominal Site
n=62 Participants
Following baseline sample collection participants had ChloraPrep applied to their abdominal test site for 30 seconds and dry for 3 minutes.
|
Experimental Prep - Inguinal Site
n=62 Participants
Following baseline sample collection participants had 3M CHG/IPA Prep applied to their inguinal test site for 2 minutes and dry for 3 minutes.
|
Active Comparator Prep - Inguinal Site
n=62 Participants
Following baseline sample collection participants had ChloraPrep applied to their inguinal test site for 2 minutes and dry for 3 minutes.
|
Experimental Prep - Abdominal Site
n=62 Participants
Following baseline sample collection participants had 3M CHG/IPA Prep applied to their abdominal test site for 30 seconds and dry for 3 minutes.
|
|---|---|---|---|---|
|
Measurement of Skin Flora Recovery Post-prep Application
72 hour timepoint
|
0.92 log10 CFU/cm^2
Standard Deviation 1.05
|
1.94 log10 CFU/cm^2
Standard Deviation 1.41
|
2.13 log10 CFU/cm^2
Standard Deviation 1.30
|
0.89 log10 CFU/cm^2
Standard Deviation 1.11
|
|
Measurement of Skin Flora Recovery Post-prep Application
48 hour timepoint
|
1.15 log10 CFU/cm^2
Standard Deviation 1.02
|
1.97 log10 CFU/cm^2
Standard Deviation 1.19
|
1.82 log10 CFU/cm^2
Standard Deviation 1.10
|
1.39 log10 CFU/cm^2
Standard Deviation 1.27
|
|
Measurement of Skin Flora Recovery Post-prep Application
96 hour timepoint
|
1.17 log10 CFU/cm^2
Standard Deviation 1.18
|
2.39 log10 CFU/cm^2
Standard Deviation 1.48
|
2.46 log10 CFU/cm^2
Standard Deviation 1.52
|
1.21 log10 CFU/cm^2
Standard Deviation 1.20
|
SECONDARY outcome
Timeframe: 10-minute post-treatment, 48-hours post-treatment, 72-hours post-treatment and 96-hours post-treatmentPopulation: The secondary analysis data set used a Modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of either \> or equal to 3.0 log10 CFU/cm\^2 on the abdomen test site or 5.0 log10 CFU/cm\^2 on the inguinal test
Log10 CFU/cm\^2 regrowth of skin flora, relative to 10-minute post-treatment log10 CFU/cm\^2, at 3 defined post-treatment sampling times.
Outcome measures
| Measure |
Active Comparator Prep - Abdominal Site
n=62 Participants
Following baseline sample collection participants had ChloraPrep applied to their abdominal test site for 30 seconds and dry for 3 minutes.
|
Experimental Prep - Inguinal Site
n=62 Participants
Following baseline sample collection participants had 3M CHG/IPA Prep applied to their inguinal test site for 2 minutes and dry for 3 minutes.
|
Active Comparator Prep - Inguinal Site
n=62 Participants
Following baseline sample collection participants had ChloraPrep applied to their inguinal test site for 2 minutes and dry for 3 minutes.
|
Experimental Prep - Abdominal Site
n=62 Participants
Following baseline sample collection participants had 3M CHG/IPA Prep applied to their abdominal test site for 30 seconds and dry for 3 minutes.
|
|---|---|---|---|---|
|
Change in Skin Flora Relative to 10 Minutes Post-prep Application
72 hour timepoint
|
-0.49 log10 CFU/cm^2
Standard Deviation 1.35
|
0.21 log10 CFU/cm^2
Standard Deviation 1.63
|
0.75 log10 CFU/cm^2
Standard Deviation 1.78
|
-0.57 log10 CFU/cm^2
Standard Deviation 1.16
|
|
Change in Skin Flora Relative to 10 Minutes Post-prep Application
96 hour timepoint
|
-0.25 log10 CFU/cm^2
Standard Deviation 1.55
|
0.66 log10 CFU/cm^2
Standard Deviation 2.04
|
1.08 log10 CFU/cm^2
Standard Deviation 1.81
|
-0.24 log10 CFU/cm^2
Standard Deviation 1.35
|
|
Change in Skin Flora Relative to 10 Minutes Post-prep Application
48 hour timepoint
|
-0.26 log10 CFU/cm^2
Standard Deviation 1.37
|
0.24 log10 CFU/cm^2
Standard Deviation 1.42
|
0.44 log10 CFU/cm^2
Standard Deviation 1.56
|
-0.07 log10 CFU/cm^2
Standard Deviation 1.34
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Assessed at baseline (pre-treatment) and 10 minutes post-treatment, 48 hours post-treatment, 72 hours post-treatment, 96 hours post-treatmentPopulation: Subjects meeting required baseline counts: greater or equal to 3.00 log10 CFU/cm\^2 on the abdominal region and greater than or or equal to 5.00 log10 CFU/cm\^2 on the inguinal region.
Skin irritation (dryness, edema, erythema, rash) assessed on the test sites using a 0-3 rating scale: 0=no reaction, 1=mild, 2=moderate, 3=severe.
Outcome measures
| Measure |
Active Comparator Prep - Abdominal Site
n=62 Participants
Following baseline sample collection participants had ChloraPrep applied to their abdominal test site for 30 seconds and dry for 3 minutes.
|
Experimental Prep - Inguinal Site
n=62 Participants
Following baseline sample collection participants had 3M CHG/IPA Prep applied to their inguinal test site for 2 minutes and dry for 3 minutes.
|
Active Comparator Prep - Inguinal Site
n=62 Participants
Following baseline sample collection participants had ChloraPrep applied to their inguinal test site for 2 minutes and dry for 3 minutes.
|
Experimental Prep - Abdominal Site
n=62 Participants
Following baseline sample collection participants had 3M CHG/IPA Prep applied to their abdominal test site for 30 seconds and dry for 3 minutes.
|
|---|---|---|---|---|
|
Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment
Dryness:10-minute post-treatment rating=0
|
62 sites
|
62 sites
|
62 sites
|
62 sites
|
|
Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment
Dryness:48 hours post-treatment rating=0
|
62 sites
|
62 sites
|
62 sites
|
62 sites
|
|
Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment
Edema:10 min post-treatment rating=0
|
62 sites
|
62 sites
|
62 sites
|
62 sites
|
|
Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment
Edema:72 hours post-treatment rating=0
|
62 sites
|
62 sites
|
62 sites
|
62 sites
|
|
Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment
Erythema:Baseline pre-treatment rating=0
|
62 sites
|
62 sites
|
62 sites
|
62 sites
|
|
Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment
Erythema:10 min post-treatment rating=0
|
62 sites
|
62 sites
|
62 sites
|
62 sites
|
|
Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment
Erythema:48 hours post-treatment rating=0
|
62 sites
|
62 sites
|
62 sites
|
62 sites
|
|
Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment
Erythema:96 hours post-treatment rating=0
|
62 sites
|
62 sites
|
62 sites
|
62 sites
|
|
Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment
Rash:10 min post-treatment rating=0
|
62 sites
|
62 sites
|
62 sites
|
62 sites
|
|
Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment
Dryness:Baseline pre-treatment rating=0
|
62 sites
|
62 sites
|
62 sites
|
62 sites
|
|
Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment
Dryness:72 hours post-treatment rating=0
|
62 sites
|
62 sites
|
62 sites
|
62 sites
|
|
Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment
Dryness:96 hours post-treatment rating=0
|
62 sites
|
62 sites
|
62 sites
|
62 sites
|
|
Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment
Edema:Baseline pre-treatment rating=0
|
62 sites
|
62 sites
|
62 sites
|
62 sites
|
|
Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment
Edema:48 hours post-treatment rating=0
|
62 sites
|
62 sites
|
62 sites
|
62 sites
|
|
Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment
Edema:96 hours post-treatment rating=0
|
62 sites
|
62 sites
|
62 sites
|
62 sites
|
|
Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment
Erythema:72 hours post-treatment rating=0
|
62 sites
|
62 sites
|
62 sites
|
62 sites
|
|
Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment
Rash:Baseline pre-treatment rating=0
|
62 sites
|
62 sites
|
62 sites
|
62 sites
|
|
Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment
Rash:48 hours post-treatment rating=0
|
62 sites
|
62 sites
|
62 sites
|
62 sites
|
|
Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment
Rash:72 hours post-treatment rating=0
|
62 sites
|
62 sites
|
62 sites
|
62 sites
|
|
Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment
Rash:96 hours post-treatment rating=0
|
62 sites
|
62 sites
|
62 sites
|
62 sites
|
Adverse Events
3M CHG/IPA Prep Abdominal Region
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ChloraPrep CHG/IPA Abdominal Region
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
3M CHG/IPA Prep Inguinal Region
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ChloraPrep CHG/IPA Inguinal Region
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