Trial Outcomes & Findings for In Vivo Patient Preoperative Skin Prep Persistence (NCT NCT02447497)
NCT ID: NCT02447497
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 two defined post-prep sampling times relative to baseline.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
Baseline, 48 hours and 72 hours post-prep application
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 provided two abdomen test sites, left or right, and/or two inguinal test sites, left or right. A total of 25 subjects were randomized to the abdomen region and 23 subjects were randomized to the inguinal region resulting in 27 subjects providing 96 application test sites on two anatomical regions.
Unit of analysis: Test sites on skin
Participant milestones
| Measure |
3M CHG/IPA - Abdominal Region
Experimental CHG/IPA Prep was randomly assigned to the left or right side of the abdominal test site
|
Normal Saline - Abdominal Region
Saline control was randomly assigned to the left or right side of the abdominal test site
|
3M CHG/IPA Prep - Inguinal Region
Experimental CHG/IPA Prep was randomly assigned to the left or right side of the inguinal test site
|
Normal Saline - Inguinal Region
Saline control was randomly assigned to the left or right side of the inguinal test site
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
25 25
|
25 25
|
23 23
|
23 23
|
|
Overall Study
COMPLETED
|
19 19
|
19 19
|
21 21
|
21 21
|
|
Overall Study
NOT COMPLETED
|
6 6
|
6 6
|
2 2
|
2 2
|
Reasons for withdrawal
| Measure |
3M CHG/IPA - Abdominal Region
Experimental CHG/IPA Prep was randomly assigned to the left or right side of the abdominal test site
|
Normal Saline - Abdominal Region
Saline control was randomly assigned to the left or right side of the abdominal test site
|
3M CHG/IPA Prep - Inguinal Region
Experimental CHG/IPA Prep was randomly assigned to the left or right side of the inguinal test site
|
Normal Saline - Inguinal Region
Saline control was randomly assigned to the left or right side of the inguinal test site
|
|---|---|---|---|---|
|
Overall Study
Did not meet treatment day baseline.
|
6
|
5
|
2
|
2
|
|
Overall Study
Dressing was compromised
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
Baseline characteristics by cohort
| Measure |
3M CHG/IPA - Abdominal Region - Left or Right
n=25 Test sites on skin
Experimental CHG/IPA Prep was randomly assigned to the left or right side of the abdominal test site
|
Normal Saline - Abdominal Region - Left or Right
n=25 Test sites on skin
Saline control was randomly assigned to the left or right side of the abdominal test site
|
3M CHG/IPA Prep - Inguinal Region - Left or Right
n=23 Test sites on skin
Experimental CHG/IPA Prep was randomly assigned to the left or right side of the inguinal test site
|
Normal Saline - Inguinal Region - Left or Right
n=23 Test sites on skin
Saline control was randomly assigned to the left or right side of the inguinal test site
|
Total
n=96 Test sites on skin
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
Between 18 and 65 years
|
22 Test sites on skin
n=247 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
22 Test sites on skin
n=74 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
20 Test sites on skin
n=246 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
20 Test sites on skin
n=245 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
84 Test sites on skin
n=236 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
|
Age, Customized
>=66 years
|
3 Test sites on skin
n=247 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
3 Test sites on skin
n=74 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
3 Test sites on skin
n=246 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
3 Test sites on skin
n=308 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
12 Test sites on skin
n=96 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
|
Sex/Gender, Customized
Female
|
5 Test sites on skin
n=247 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
5 Test sites on skin
n=74 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
3 Test sites on skin
n=246 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
3 Test sites on skin
n=308 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
16 Test sites on skin
n=96 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
|
Sex/Gender, Customized
Male
|
20 Test sites on skin
n=247 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
20 Test sites on skin
n=74 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
20 Test sites on skin
n=246 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
20 Test sites on skin
n=245 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
80 Test sites on skin
n=236 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Test sites on skin
n=247 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
0 Test sites on skin
n=74 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
0 Test sites on skin
n=246 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
0 Test sites on skin
n=245 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
0 Test sites on skin
n=236 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
|
Race/Ethnicity, Customized
Asian
|
12 Test sites on skin
n=247 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
12 Test sites on skin
n=74 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
11 Test sites on skin
n=246 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
11 Test sites on skin
n=245 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
46 Test sites on skin
n=236 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Test sites on skin
n=247 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
0 Test sites on skin
n=74 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
0 Test sites on skin
n=246 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
0 Test sites on skin
n=245 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
0 Test sites on skin
n=236 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Test sites on skin
n=247 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
3 Test sites on skin
n=74 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
4 Test sites on skin
n=246 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
4 Test sites on skin
n=245 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
14 Test sites on skin
n=236 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
|
Race/Ethnicity, Customized
White
|
10 Test sites on skin
n=247 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
10 Test sites on skin
n=74 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
8 Test sites on skin
n=246 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
8 Test sites on skin
n=245 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
36 Test sites on skin
n=236 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
|
Race/Ethnicity, Customized
More than one race
|
0 Test sites on skin
n=247 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
0 Test sites on skin
n=74 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
0 Test sites on skin
n=246 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
0 Test sites on skin
n=245 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
0 Test sites on skin
n=96 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
|
Race/Ethnicity, Customized
Unknown or not reported
|
0 Test sites on skin
n=247 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
0 Test sites on skin
n=74 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
0 Test sites on skin
n=246 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
0 Test sites on skin
n=245 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
0 Test sites on skin
n=236 Test sites on skin • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
25 participants
n=7 Participants • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
23 participants
n=5 Participants • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
23 participants
n=4 Participants • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
27 participants
n=21 Participants • Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left).
|
PRIMARY outcome
Timeframe: Baseline, 48 hours and 72 hours post-prep applicationPopulation: Number analyzed includes subjects who met baseline requirements
The primary measure of persistence is the suppression of regrowth recovery relative to baseline (log10 CFU/cm\^2) of skin flora at two defined post-prep sampling times relative to baseline.
Outcome measures
| Measure |
Normal Saline - Abdominal Region
n=20 Participants
Saline control was randomly assigned to the left or right side of the abdominal test site
|
3M CHG/IPA Prep - Abdominal Region
n=19 Participants
Experimental CHG/IPA Prep was randomly assigned to the left or right side of the abdominal test site
|
Normal Saline - Inguinal Region
n=21 Participants
Saline control was randomly assigned to the left or right side of the inguinal test site
|
3M CHG/IPA Prep - Inguinal Region
n=21 Participants
Experimental CHG/IPA Prep was randomly assigned to the left or right side of the inguinal test site
|
|---|---|---|---|---|
|
Measurement of Skin Flora Recovery Post-prep Application Relative to Baseline
48-hour timepoint
|
0.91 Log10 CFU/cm^2
Standard Deviation 0.78
|
2.81 Log10 CFU/cm^2
Standard Deviation 0.97
|
0.59 Log10 CFU/cm^2
Standard Deviation 0.79
|
2.96 Log10 CFU/cm^2
Standard Deviation 1.07
|
|
Measurement of Skin Flora Recovery Post-prep Application Relative to Baseline
72-hour timepoint
|
0.93 Log10 CFU/cm^2
Standard Deviation 1.07
|
2.44 Log10 CFU/cm^2
Standard Deviation 1.34
|
0.51 Log10 CFU/cm^2
Standard Deviation 0.73
|
2.91 Log10 CFU/cm^2
Standard Deviation 1.60
|
SECONDARY outcome
Timeframe: 48 hours and 72 hours post-product applicationPopulation: Data from the 48-hour and 72-hour timepoints were combined for each skin condition category of erythema, edema, rash and erythema since all ratings for all subjects at all timepoints were scored as zero (no reaction) for all subjects.
For the conditions of erythema, edema, rash, and dryness, a rating of 0 (no reaction), 1 (mild and/or transient, limited to sensitive area), 2 (moderate, persisting over much of the product-exposed area), or 3 (severe, extending over most or all of the product-exposed area) was recorded on the Skin Irritation Rating form of the eCRF.
Outcome measures
| Measure |
Normal Saline - Abdominal Region
n=25 Participants
Saline control was randomly assigned to the left or right side of the abdominal test site
|
3M CHG/IPA Prep - Abdominal Region
n=25 Participants
Experimental CHG/IPA Prep was randomly assigned to the left or right side of the abdominal test site
|
Normal Saline - Inguinal Region
n=23 Participants
Saline control was randomly assigned to the left or right side of the inguinal test site
|
3M CHG/IPA Prep - Inguinal Region
n=23 Participants
Experimental CHG/IPA Prep was randomly assigned to the left or right side of the inguinal test site
|
|---|---|---|---|---|
|
Safety as Assessed by Skin Irritation Scores Coded by Study Staff
Erythema: 48-hour timepoint
|
0 Score on a scale
Standard Deviation 0
|
0 Score on a scale
Standard Deviation 0
|
0 Score on a scale
Standard Deviation 0
|
0 Score on a scale
Standard Deviation 0
|
|
Safety as Assessed by Skin Irritation Scores Coded by Study Staff
Erythema: 72-hour timepoint
|
0 Score on a scale
Standard Deviation 0
|
0 Score on a scale
Standard Deviation 0
|
0 Score on a scale
Standard Deviation 0
|
0 Score on a scale
Standard Deviation 0
|
|
Safety as Assessed by Skin Irritation Scores Coded by Study Staff
Edema: 48-hour timepoint
|
0 Score on a scale
Standard Deviation 0
|
0 Score on a scale
Standard Deviation 0
|
0 Score on a scale
Standard Deviation 0
|
0 Score on a scale
Standard Deviation 0
|
|
Safety as Assessed by Skin Irritation Scores Coded by Study Staff
Edema: 72-hour timepoint
|
0 Score on a scale
Standard Deviation 0
|
0 Score on a scale
Standard Deviation 0
|
0 Score on a scale
Standard Deviation 0
|
0 Score on a scale
Standard Deviation 0
|
|
Safety as Assessed by Skin Irritation Scores Coded by Study Staff
Rash: 48-hour timepoint
|
0 Score on a scale
Standard Deviation 0
|
0 Score on a scale
Standard Deviation 0
|
0 Score on a scale
Standard Deviation 0
|
0 Score on a scale
Standard Deviation 0
|
|
Safety as Assessed by Skin Irritation Scores Coded by Study Staff
Rash: 72-hour timepoint
|
0 Score on a scale
Standard Deviation 0
|
0 Score on a scale
Standard Deviation 0
|
0 Score on a scale
Standard Deviation 0
|
0 Score on a scale
Standard Deviation 0
|
|
Safety as Assessed by Skin Irritation Scores Coded by Study Staff
Dryness: 48-hour timepoint
|
0 Score on a scale
Standard Deviation 0
|
0 Score on a scale
Standard Deviation 0
|
0 Score on a scale
Standard Deviation 0
|
0 Score on a scale
Standard Deviation 0
|
|
Safety as Assessed by Skin Irritation Scores Coded by Study Staff
Dryness: 72-hour timepoint
|
0 Score on a scale
Standard Deviation 0
|
0 Score on a scale
Standard Deviation 0
|
0 Score on a scale
Standard Deviation 0
|
0 Score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: To 72 hours post treatmentPopulation: Adverse event reports through the treatment period, that is both 48 and 72 hours post dose.
Number of subjects with adverse events as self-reported or identified by study staff
Outcome measures
| Measure |
Normal Saline - Abdominal Region
n=25 Participants
Saline control was randomly assigned to the left or right side of the abdominal test site
|
3M CHG/IPA Prep - Abdominal Region
n=25 Participants
Experimental CHG/IPA Prep was randomly assigned to the left or right side of the abdominal test site
|
Normal Saline - Inguinal Region
n=23 Participants
Saline control was randomly assigned to the left or right side of the inguinal test site
|
3M CHG/IPA Prep - Inguinal Region
n=23 Participants
Experimental CHG/IPA Prep was randomly assigned to the left or right side of the inguinal test site
|
|---|---|---|---|---|
|
Safety as Assessed by Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
3M CHG/IPA - Abdomen
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normal Saline - Abdomen
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
3M CHG/IPA - Inguinal
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normal Saline - Inguinal
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