Trial Outcomes & Findings for In Vivo Efficacy Study of Patient Preoperative Preps (NCT NCT02203591)
NCT ID: NCT02203591
Last Updated: 2020-11-23
Results Overview
On the abdominal region a responder is a subject with a 2 log10/cm\^2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at the 6-hour sample collection time. On the inguinal region a responder is a subject with a 3 log10/cm\^2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at the 6-hour sample collection time.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
738 participants
Primary outcome timeframe
baseline, 10 minutes post-product application and 6 hours post-product application
Results posted on
2020-11-23
Participant Flow
This is a randomized, paired comparison design where each subject received 2 of the planned treatments, 1 on the left side \& 1 on the right. Each subject provided 2 abdomen test sties, left \& right and/or 2 inguen test sites, left \& right. 569 subjects were randomized for the abdomen region \& 404 subjects randomized for the inguen region resulting in 738 subjects providing 1946 applications of test products on 2 anatomical regions.
Unit of analysis: test sites on skin
Participant milestones
| Measure |
3M CHG/IPA Prep C - Abdominal
Applied topically to the abdominal region for 30 seconds.
|
3M CHG/IPA Prep CH - Abdominal
Applied topically to the abdominal region for 30 seconds.
|
ChloraPrep - Abdominal
Applied topically to the abdominal region for 30 seconds.
|
Normal Saline - Abdominal
Applied topically to the abdominal region for 30 seconds.
|
3M CHG/IPA Prep C - Inguinal
Applied topically to the inguinal region for 2 minutes.
|
3M CHG/IPA Prep CH - Inguinal
Applied topically to the inguinal region for 2 minutes.
|
ChloraPrep - Inguinal
Applied topically to the inguinal region for 2 minutes.
|
Normal Saline - Inguinal
Applied topically to the inguinal region for 2 minutes.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
343 343
|
344 344
|
347 347
|
104 104
|
242 242
|
244 244
|
248 248
|
74 74
|
|
Overall Study
COMPLETED
|
196 196
|
202 202
|
196 196
|
59 59
|
208 208
|
209 209
|
219 219
|
61 61
|
|
Overall Study
NOT COMPLETED
|
147 147
|
142 142
|
151 151
|
45 45
|
34 34
|
35 35
|
29 29
|
13 13
|
Reasons for withdrawal
| Measure |
3M CHG/IPA Prep C - Abdominal
Applied topically to the abdominal region for 30 seconds.
|
3M CHG/IPA Prep CH - Abdominal
Applied topically to the abdominal region for 30 seconds.
|
ChloraPrep - Abdominal
Applied topically to the abdominal region for 30 seconds.
|
Normal Saline - Abdominal
Applied topically to the abdominal region for 30 seconds.
|
3M CHG/IPA Prep C - Inguinal
Applied topically to the inguinal region for 2 minutes.
|
3M CHG/IPA Prep CH - Inguinal
Applied topically to the inguinal region for 2 minutes.
|
ChloraPrep - Inguinal
Applied topically to the inguinal region for 2 minutes.
|
Normal Saline - Inguinal
Applied topically to the inguinal region for 2 minutes.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Did not meet treatment day baseline
|
147
|
141
|
150
|
45
|
33
|
35
|
29
|
12
|
|
Overall Study
Discontinued early due to compromised test sites
|
0
|
1
|
1
|
0
|
1
|
0
|
0
|
1
|
Baseline Characteristics
In Vivo Efficacy Study of Patient Preoperative Preps
Baseline characteristics by cohort
| Measure |
3M CHG/IPA Prep C - Abdominal
n=343 test sites on skin
Applied topically for 30 seconds to the abdominal test site
|
3M CHG/IPA Prep CH - Abdominal
n=344 test sites on skin
Applied topically for 30 seconds to the abdominal test site
|
ChloraPrep - Abdominal
n=347 test sites on skin
Applied topically for 30 seconds to the abdominal test site
|
Saline - Abdominal
n=104 test sites on skin
Applied topically for 30 seconds to the abdominal test site
|
3M CHG/IPA Prep C - Inguinal
n=242 test sites on skin
Applied topically for 2 minutes to the inguinal test site
|
3M CHG/IPA Prep CH - Inguinal
n=244 test sites on skin
Applied topically for 2 minutes to the inguinal test site
|
ChloraPrep - Inguinal
n=248 test sites on skin
Applied topically for 2 minutes to the inguinal test site
|
Saline - Inguinal
n=74 test sites on skin
Applied topically for 2 minutes to the inguinal test site
|
Total
n=1946 test sites on skin
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
333 Participants
n=5 Participants
|
338 Participants
n=7 Participants
|
332 Participants
n=5 Participants
|
102 Participants
n=4 Participants
|
236 Participants
n=21 Participants
|
236 Participants
n=8 Participants
|
245 Participants
n=8 Participants
|
73 Participants
n=24 Participants
|
1895 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
51 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
92 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
64 Participants
n=8 Participants
|
67 Participants
n=8 Participants
|
23 Participants
n=24 Participants
|
538 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
251 Participants
n=5 Participants
|
245 Participants
n=7 Participants
|
242 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
186 Participants
n=21 Participants
|
180 Participants
n=8 Participants
|
181 Participants
n=8 Participants
|
51 Participants
n=24 Participants
|
1408 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
28 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
48 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
18 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Hispanic / Latino
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
14 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
76 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiin or Other Pacific Islander
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
10 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
White
|
308 Participants
n=5 Participants
|
320 Participants
n=7 Participants
|
316 Participants
n=5 Participants
|
96 Participants
n=4 Participants
|
222 Participants
n=21 Participants
|
222 Participants
n=8 Participants
|
221 Participants
n=8 Participants
|
71 Participants
n=24 Participants
|
1776 Participants
n=42 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
28 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
343 participants
n=5 Participants
|
344 participants
n=7 Participants
|
347 participants
n=5 Participants
|
104 participants
n=4 Participants
|
242 participants
n=21 Participants
|
244 participants
n=8 Participants
|
248 participants
n=8 Participants
|
74 participants
n=24 Participants
|
973 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: baseline, 10 minutes post-product application and 6 hours post-product applicationOn the abdominal region a responder is a subject with a 2 log10/cm\^2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at the 6-hour sample collection time. On the inguinal region a responder is a subject with a 3 log10/cm\^2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at the 6-hour sample collection time.
Outcome measures
| Measure |
3M CHG/IPA Prep CH - Inguinal
n=209 Participants
Applied topically to the inguinal region for 2 minutes.
|
ChloraPrep - Inguinal
n=219 Participants
Applied topically to the inguinal region for 2 minutes.
|
Normal Saline - Inguinal
n=61 Participants
Applied topically to the inguinal region for 2 minutes.
|
3M CHG/IPA Prep C - Abdominal
n=196 Participants
Applied topically to the abdominal region for 30 seconds.
|
3M CHG/IPA Prep CH - Abdominal
n=202 Participants
Applied topically to the abdominal region for 30 seconds.
|
ChloraPrep - Abdominal
n=196 Participants
Applied topically to the abdominal region for 30 seconds.
|
Normal Saline - Abdominal
n=59 Participants
Applied topically to the abdominal region for 30 seconds.
|
3M CHG/IPA Prep C - Inguinal
n=208 Participants
Applied topically to the inguinal region for 2 minutes.
|
|---|---|---|---|---|---|---|---|---|
|
Responder Rate
|
98 Participants
|
116 Participants
|
1 Participants
|
159 Participants
|
165 Participants
|
163 Participants
|
5 Participants
|
81 Participants
|
PRIMARY outcome
Timeframe: Baseline and 10 minutes10 minute log reduction
Outcome measures
| Measure |
3M CHG/IPA Prep CH - Inguinal
Applied topically to the inguinal region for 2 minutes.
|
ChloraPrep - Inguinal
Applied topically to the inguinal region for 2 minutes.
|
Normal Saline - Inguinal
Applied topically to the inguinal region for 2 minutes.
|
3M CHG/IPA Prep C - Abdominal
n=208 Participants
Applied topically to the abdominal region for 30 seconds.
|
3M CHG/IPA Prep CH - Abdominal
n=209 Participants
Applied topically to the abdominal region for 30 seconds.
|
ChloraPrep - Abdominal
n=219 Participants
Applied topically to the abdominal region for 30 seconds.
|
Normal Saline - Abdominal
Applied topically to the abdominal region for 30 seconds.
|
3M CHG/IPA Prep C - Inguinal
Applied topically to the inguinal region for 2 minutes.
|
|---|---|---|---|---|---|---|---|---|
|
Alternative Primary
|
—
|
—
|
—
|
2.84 log10/cm^2
Standard Deviation 1.19
|
2.99 log10/cm^2
Standard Deviation 1.12
|
3.17 log10/cm^2
Standard Deviation 1.24
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 hoursPopulation: The primary analysis dataset used a mITT population. Subjects were excluded who did not meet the treatment day baseline requirements (stated in the Inclusion/Exclusion criteria).
Log10/cm\^2 reduction of skin flora, relative to treatment day baseline, 6 hours post-treatment application
Outcome measures
| Measure |
3M CHG/IPA Prep CH - Inguinal
n=209 Participants
Applied topically to the inguinal region for 2 minutes.
|
ChloraPrep - Inguinal
n=219 Participants
Applied topically to the inguinal region for 2 minutes.
|
Normal Saline - Inguinal
n=61 Participants
Applied topically to the inguinal region for 2 minutes.
|
3M CHG/IPA Prep C - Abdominal
n=196 Participants
Applied topically to the abdominal region for 30 seconds.
|
3M CHG/IPA Prep CH - Abdominal
n=202 Participants
Applied topically to the abdominal region for 30 seconds.
|
ChloraPrep - Abdominal
n=196 Participants
Applied topically to the abdominal region for 30 seconds.
|
Normal Saline - Abdominal
n=59 Participants
Applied topically to the abdominal region for 30 seconds.
|
3M CHG/IPA Prep C - Inguinal
n=208 Participants
Applied topically to the inguinal region for 2 minutes.
|
|---|---|---|---|---|---|---|---|---|
|
Reduction of Skin Flora 6 Hours Post-treatment
|
3.49 log10/cm^2 skin flora
Standard Deviation 1.329
|
3.69 log10/cm^2 skin flora
Standard Deviation 1.286
|
1.23 log10/cm^2 skin flora
Standard Deviation 0.732
|
2.83 log10/cm^2 skin flora
Standard Deviation 0.851
|
2.86 log10/cm^2 skin flora
Standard Deviation 0.899
|
2.83 log10/cm^2 skin flora
Standard Deviation 0.971
|
1.00 log10/cm^2 skin flora
Standard Deviation 0.971
|
3.46 log10/cm^2 skin flora
Standard Deviation 1.312
|
SECONDARY outcome
Timeframe: 10 minutesPopulation: The primary analysis dataset used a mITT population. Subjects were excluded who did not meet the treatment day baseline requirements (stated in the Inclusion/Exclusion criteria).
Log10/cm\^2 reduction of skin flora, relative to treatment day baseline (log10/cm\^2) at 10 minutes post-treatment application
Outcome measures
| Measure |
3M CHG/IPA Prep CH - Inguinal
n=209 Participants
Applied topically to the inguinal region for 2 minutes.
|
ChloraPrep - Inguinal
n=219 Participants
Applied topically to the inguinal region for 2 minutes.
|
Normal Saline - Inguinal
n=61 Participants
Applied topically to the inguinal region for 2 minutes.
|
3M CHG/IPA Prep C - Abdominal
n=196 Participants
Applied topically to the abdominal region for 30 seconds.
|
3M CHG/IPA Prep CH - Abdominal
n=202 Participants
Applied topically to the abdominal region for 30 seconds.
|
ChloraPrep - Abdominal
n=196 Participants
Applied topically to the abdominal region for 30 seconds.
|
Normal Saline - Abdominal
n=59 Participants
Applied topically to the abdominal region for 30 seconds.
|
3M CHG/IPA Prep C - Inguinal
n=208 Participants
Applied topically to the inguinal region for 2 minutes.
|
|---|---|---|---|---|---|---|---|---|
|
Reduction of Skin Flora 10 Minutes Post-treatment
|
2.99 log10/cm^2 skin flora
Standard Deviation 1.125
|
3.17 log10/cm^2 skin flora
Standard Deviation 1.243
|
1.01 log10/cm^2 skin flora
Standard Deviation 0.668
|
2.78 log10/cm^2 skin flora
Standard Deviation 0.935
|
2.73 log10/cm^2 skin flora
Standard Deviation 1.002
|
2.75 log10/cm^2 skin flora
Standard Deviation 0.973
|
0.76 log10/cm^2 skin flora
Standard Deviation 0.814
|
2.84 log10/cm^2 skin flora
Standard Deviation 1.191
|
SECONDARY outcome
Timeframe: 6 hours post-treatmentPopulation: The primary analysis dataset used a mITT population. Subjects were excluded who did not meet the treatment day baseline requirements (stated in the Inclusion/Exclusion criteria).
Log10/cm\^2 recovery of skin flora at 6 hours following application of treatment
Outcome measures
| Measure |
3M CHG/IPA Prep CH - Inguinal
n=209 Participants
Applied topically to the inguinal region for 2 minutes.
|
ChloraPrep - Inguinal
n=219 Participants
Applied topically to the inguinal region for 2 minutes.
|
Normal Saline - Inguinal
n=60 Participants
Applied topically to the inguinal region for 2 minutes.
|
3M CHG/IPA Prep C - Abdominal
n=196 Participants
Applied topically to the abdominal region for 30 seconds.
|
3M CHG/IPA Prep CH - Abdominal
n=201 Participants
Applied topically to the abdominal region for 30 seconds.
|
ChloraPrep - Abdominal
n=196 Participants
Applied topically to the abdominal region for 30 seconds.
|
Normal Saline - Abdominal
n=59 Participants
Applied topically to the abdominal region for 30 seconds.
|
3M CHG/IPA Prep C - Inguinal
n=208 Participants
Applied topically to the inguinal region for 2 minutes.
|
|---|---|---|---|---|---|---|---|---|
|
Skin Flora Recovery 6-hours Post-treatment
|
2.73 log10/cm^2 skin flora
Standard Deviation 1.220
|
2.58 log10/cm^2 skin flora
Standard Deviation 1.182
|
4.85 log10/cm^2 skin flora
Standard Deviation 0.749
|
0.80 log10/cm^2 skin flora
Standard Deviation 0.840
|
0.74 log10/cm^2 skin flora
Standard Deviation 0.789
|
0.81 log10/cm^2 skin flora
Standard Deviation 0.935
|
2.65 log10/cm^2 skin flora
Standard Deviation 0.886
|
2.76 log10/cm^2 skin flora
Standard Deviation 1.202
|
SECONDARY outcome
Timeframe: 10 minute post-product applicationPopulation: The primary analysis dataset used a mITT population. Subjects were excluded who did not meet the treatment day baseline requirements (stated in the Inclusion/Exclusion criteria).
Log10/cm\^2 recovery of skin flora at 10 minutes following application of study treatments.
Outcome measures
| Measure |
3M CHG/IPA Prep CH - Inguinal
n=208 Participants
Applied topically to the inguinal region for 2 minutes.
|
ChloraPrep - Inguinal
n=218 Participants
Applied topically to the inguinal region for 2 minutes.
|
Normal Saline - Inguinal
n=60 Participants
Applied topically to the inguinal region for 2 minutes.
|
3M CHG/IPA Prep C - Abdominal
n=196 Participants
Applied topically to the abdominal region for 30 seconds.
|
3M CHG/IPA Prep CH - Abdominal
n=201 Participants
Applied topically to the abdominal region for 30 seconds.
|
ChloraPrep - Abdominal
n=196 Participants
Applied topically to the abdominal region for 30 seconds.
|
Normal Saline - Abdominal
n=59 Participants
Applied topically to the abdominal region for 30 seconds.
|
3M CHG/IPA Prep C - Inguinal
n=208 Participants
Applied topically to the inguinal region for 2 minutes.
|
|---|---|---|---|---|---|---|---|---|
|
Skin Flora Recovery 10 Minutes Post-treatment
|
3.21 log10/cm^2 skin flora
Standard Deviation 1.042
|
3.08 log10/cm^2 skin flora
Standard Deviation 1.137
|
5.08 log10/cm^2 skin flora
Standard Deviation 0.676
|
0.85 log10/cm^2 skin flora
Standard Deviation 0.947
|
0.88 log10/cm^2 skin flora
Standard Deviation 0.984
|
0.90 log10/cm^2 skin flora
Standard Deviation 0.938
|
2.88 log10/cm^2 skin flora
Standard Deviation 0.703
|
3.39 log10/cm^2 skin flora
Standard Deviation 1.096
|
SECONDARY outcome
Timeframe: BaselinePopulation: The primary analysis dataset used a mITT population. Subjects were excluded who did not meet the treatment day baseline requirements (stated in the Inclusion/Exclusion criteria).
Log10/cm\^2 baseline skin flora for abdominal and inguinal regions
Outcome measures
| Measure |
3M CHG/IPA Prep CH - Inguinal
n=209 Participants
Applied topically to the inguinal region for 2 minutes.
|
ChloraPrep - Inguinal
n=219 Participants
Applied topically to the inguinal region for 2 minutes.
|
Normal Saline - Inguinal
n=61 Participants
Applied topically to the inguinal region for 2 minutes.
|
3M CHG/IPA Prep C - Abdominal
n=196 Participants
Applied topically to the abdominal region for 30 seconds.
|
3M CHG/IPA Prep CH - Abdominal
n=202 Participants
Applied topically to the abdominal region for 30 seconds.
|
ChloraPrep - Abdominal
n=196 Participants
Applied topically to the abdominal region for 30 seconds.
|
Normal Saline - Abdominal
n=59 Participants
Applied topically to the abdominal region for 30 seconds.
|
3M CHG/IPA Prep C - Inguinal
n=208 Participants
Applied topically to the inguinal region for 2 minutes.
|
|---|---|---|---|---|---|---|---|---|
|
Skin Flora Baseline for the Abdomen and Inguinal Region.
|
6.21 log10/cm^2 skin flora
Standard Deviation 0.563
|
6.27 log10/cm^2 skin flora
Standard Deviation 0.618
|
6.09 log10/cm^2 skin flora
Standard Deviation 0.626
|
3.63 log10/cm^2 skin flora
Standard Deviation 0.460
|
3.61 log10/cm^2 skin flora
Standard Deviation 0.479
|
3.64 log10/cm^2 skin flora
Standard Deviation 0.487
|
3.64 log10/cm^2 skin flora
Standard Deviation 0.533
|
6.23 log10/cm^2 skin flora
Standard Deviation 0.604
|
SECONDARY outcome
Timeframe: BaselinePopulation: The primary safety analysis data set used an Intent-To-Treat (ITT) population
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 |
3M CHG/IPA Prep CH - Inguinal
n=244 test sites on skin
Applied topically to the inguinal region for 2 minutes.
|
ChloraPrep - Inguinal
n=248 test sites on skin
Applied topically to the inguinal region for 2 minutes.
|
Normal Saline - Inguinal
n=74 test sites on skin
Applied topically to the inguinal region for 2 minutes.
|
3M CHG/IPA Prep C - Abdominal
n=343 test sites on skin
Applied topically to the abdominal region for 30 seconds.
|
3M CHG/IPA Prep CH - Abdominal
n=344 test sites on skin
Applied topically to the abdominal region for 30 seconds.
|
ChloraPrep - Abdominal
n=347 test sites on skin
Applied topically to the abdominal region for 30 seconds.
|
Normal Saline - Abdominal
n=104 test sites on skin
Applied topically to the abdominal region for 30 seconds.
|
3M CHG/IPA Prep C - Inguinal
n=242 test sites on skin
Applied topically to the inguinal region for 2 minutes.
|
|---|---|---|---|---|---|---|---|---|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Dryness-No Reaction (0)
|
244 participants
|
248 participants
|
74 participants
|
343 participants
|
344 participants
|
347 participants
|
104 participants
|
240 participants
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Dryness-Mild (1)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Dryness-Moderate (2)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Dryness-Severe (3)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Edema-No Reaction (0)
|
244 participants
|
248 participants
|
74 participants
|
343 participants
|
344 participants
|
347 participants
|
104 participants
|
240 participants
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Edema-Mild (1)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Edema-Moderate (2)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Edema-Severe (3)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Erythema-No Reaction (0)
|
243 participants
|
247 participants
|
74 participants
|
340 participants
|
343 participants
|
347 participants
|
104 participants
|
239 participants
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Erythema-Mild (1)
|
1 participants
|
1 participants
|
0 participants
|
3 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Erythema-Moderate (2)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Erythema-Severe (3)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Rash-No Reaction (0)
|
244 participants
|
248 participants
|
74 participants
|
343 participants
|
344 participants
|
347 participants
|
104 participants
|
240 participants
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Rash-Mild (1)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Rash-Moderate (2)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Rash-Severe (3)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 10 minutes post-treatmentPopulation: The primary safety analysis data set used an Intent to Treat population
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 |
3M CHG/IPA Prep CH - Inguinal
n=244 test sites on skin
Applied topically to the inguinal region for 2 minutes.
|
ChloraPrep - Inguinal
n=248 test sites on skin
Applied topically to the inguinal region for 2 minutes.
|
Normal Saline - Inguinal
n=74 test sites on skin
Applied topically to the inguinal region for 2 minutes.
|
3M CHG/IPA Prep C - Abdominal
n=343 test sites on skin
Applied topically to the abdominal region for 30 seconds.
|
3M CHG/IPA Prep CH - Abdominal
n=344 test sites on skin
Applied topically to the abdominal region for 30 seconds.
|
ChloraPrep - Abdominal
n=347 test sites on skin
Applied topically to the abdominal region for 30 seconds.
|
Normal Saline - Abdominal
n=104 test sites on skin
Applied topically to the abdominal region for 30 seconds.
|
3M CHG/IPA Prep C - Inguinal
n=242 test sites on skin
Applied topically to the inguinal region for 2 minutes.
|
|---|---|---|---|---|---|---|---|---|
|
Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Erythema-Moderate (2)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Rash-Mild(1)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Dryness-No Reaction (0)
|
244 participants
|
248 participants
|
73 participants
|
343 participants
|
344 participants
|
347 participants
|
104 participants
|
242 participants
|
|
Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Dryness-Mild (1)
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Dryness-Moderate (2)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Dryness-Severe (3)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Edema-No Reaction
|
244 participants
|
247 participants
|
74 participants
|
343 participants
|
344 participants
|
347 participants
|
104 participants
|
242 participants
|
|
Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Edema-Mild (1)
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Edema-Moderate (2)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Edema-Severe (3)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Erythema-No Reaction (0)
|
242 participants
|
243 participants
|
73 participants
|
341 participants
|
343 participants
|
345 participants
|
104 participants
|
240 participants
|
|
Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Erythema-Mild (1)
|
2 participants
|
5 participants
|
1 participants
|
2 participants
|
1 participants
|
2 participants
|
0 participants
|
2 participants
|
|
Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Erythema-Severe (3)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Rash-No Reaction (0)
|
244 participants
|
248 participants
|
74 participants
|
343 participants
|
344 participants
|
347 participants
|
104 participants
|
242 participants
|
|
Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Rash-Moderate (2)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Rash-Severe (3)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 6 hours post-treatmentPopulation: The primary safety analysis dataset used an Intent-To-Treat (ITT) population
Skin irritation rating (0-3) scores for dryness, edema, erythema and rash; 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe.
Outcome measures
| Measure |
3M CHG/IPA Prep CH - Inguinal
n=244 Participants
Applied topically to the inguinal region for 2 minutes.
|
ChloraPrep - Inguinal
n=248 Participants
Applied topically to the inguinal region for 2 minutes.
|
Normal Saline - Inguinal
n=74 Participants
Applied topically to the inguinal region for 2 minutes.
|
3M CHG/IPA Prep C - Abdominal
n=343 Participants
Applied topically to the abdominal region for 30 seconds.
|
3M CHG/IPA Prep CH - Abdominal
n=344 Participants
Applied topically to the abdominal region for 30 seconds.
|
ChloraPrep - Abdominal
n=347 Participants
Applied topically to the abdominal region for 30 seconds.
|
Normal Saline - Abdominal
n=104 Participants
Applied topically to the abdominal region for 30 seconds.
|
3M CHG/IPA Prep C - Inguinal
n=242 Participants
Applied topically to the inguinal region for 2 minutes.
|
|---|---|---|---|---|---|---|---|---|
|
Safety as Assessed by Skin Irritation Score
Rash-Mild (1)
|
13 Participants
|
19 Participants
|
8 Participants
|
4 Participants
|
7 Participants
|
5 Participants
|
1 Participants
|
12 Participants
|
|
Safety as Assessed by Skin Irritation Score
Dryness-No Reaction (0)
|
240 Participants
|
241 Participants
|
73 Participants
|
334 Participants
|
330 Participants
|
336 Participants
|
101 Participants
|
240 Participants
|
|
Safety as Assessed by Skin Irritation Score
Dryness-Mild (1)
|
4 Participants
|
7 Participants
|
1 Participants
|
9 Participants
|
14 Participants
|
10 Participants
|
3 Participants
|
2 Participants
|
|
Safety as Assessed by Skin Irritation Score
Dryness-Moderate (2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Safety as Assessed by Skin Irritation Score
Dryness-Severe (3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety as Assessed by Skin Irritation Score
Edema-No Reaction (0)
|
244 Participants
|
248 Participants
|
74 Participants
|
343 Participants
|
344 Participants
|
347 Participants
|
104 Participants
|
242 Participants
|
|
Safety as Assessed by Skin Irritation Score
Edema-Mild (1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety as Assessed by Skin Irritation Score
Edema-Moderate (2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety as Assessed by Skin Irritation Score
Edema-Severe (3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety as Assessed by Skin Irritation Score
Erythema-No Reaction (0)
|
220 Participants
|
236 Participants
|
72 Participants
|
310 Participants
|
310 Participants
|
332 Participants
|
98 Participants
|
227 Participants
|
|
Safety as Assessed by Skin Irritation Score
Erythema-Mild (1)
|
24 Participants
|
12 Participants
|
2 Participants
|
32 Participants
|
33 Participants
|
15 Participants
|
6 Participants
|
15 Participants
|
|
Safety as Assessed by Skin Irritation Score
Erythema-Moderate (2)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety as Assessed by Skin Irritation Score
Erythema-Severe (3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety as Assessed by Skin Irritation Score
Rash-No Reaction (0)
|
231 Participants
|
229 Participants
|
66 Participants
|
339 Participants
|
337 Participants
|
342 Participants
|
103 Participants
|
230 Participants
|
|
Safety as Assessed by Skin Irritation Score
Rash-Moderate (2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety as Assessed by Skin Irritation Score
Rash-Severe (3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
3M CHG/IPA Prep C - Abdominal
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
3M CHG/IPA Prep CH - Abdominal
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
ChloraPrep - Abdominal
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Normal Saline - Abdominal
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
3M CHG/IPA Prep C - Inguinal
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
3M CHG/IPA Prep CH - Inguinal
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
ChloraPrep - 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
| Measure |
3M CHG/IPA Prep C - Abdominal
n=343 participants at risk
Applied topically to the abdominal region for 30 seconds.
|
3M CHG/IPA Prep CH - Abdominal
n=344 participants at risk
Applied topically to the abdominal region for 30 seconds.
|
ChloraPrep - Abdominal
n=347 participants at risk
Applied topically to the abdominal region for 30 seconds.
|
Normal Saline - Abdominal
n=104 participants at risk
Applied topically to the abdominal region for 30 seconds.
|
3M CHG/IPA Prep C - Inguinal
n=242 participants at risk
Applied topically to the inguinal region for 2 minutes.
|
3M CHG/IPA Prep CH - Inguinal
n=244 participants at risk
Applied topically to the inguinal region for 2 minutes.
|
ChloraPrep - Inguinal
n=248 participants at risk
Applied topically to the inguinal region for 2 minutes.
|
Normal Saline - Inguinal
n=74 participants at risk
Applied topically to the inguinal region for 2 minutes.
|
|---|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Mild severity
|
0.29%
1/343 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
0.58%
2/344 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
0.29%
1/347 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
0.00%
0/104 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
0.41%
1/242 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
0.82%
2/244 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
0.00%
0/248 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
0.00%
0/74 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
|
Skin and subcutaneous tissue disorders
Moderate severity
|
0.29%
1/343 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
0.29%
1/344 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
0.00%
0/347 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
0.00%
0/104 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
0.41%
1/242 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
0.41%
1/244 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
0.00%
0/248 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
0.00%
0/74 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
|
Skin and subcutaneous tissue disorders
Not related to product
|
0.00%
0/343 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
0.29%
1/344 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
0.00%
0/347 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
0.00%
0/104 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
0.00%
0/242 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
0.41%
1/244 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
0.00%
0/248 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
0.00%
0/74 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
|
Skin and subcutaneous tissue disorders
Possibly related to products
|
0.00%
0/343 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
0.00%
0/344 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
0.00%
0/347 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
0.00%
0/104 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
0.41%
1/242 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
0.00%
0/244 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
0.00%
0/248 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
0.00%
0/74 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
|
Skin and subcutaneous tissue disorders
Probably related to product
|
0.58%
2/343 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
0.58%
2/344 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
0.29%
1/347 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
0.00%
0/104 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
0.41%
1/242 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
0.82%
2/244 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
0.00%
0/248 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
0.00%
0/74 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
|
Skin and subcutaneous tissue disorders
Anticipated
|
0.58%
2/343 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
0.58%
2/344 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
0.29%
1/347 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
0.00%
0/104 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
0.83%
2/242 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
1.2%
3/244 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
0.00%
0/248 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
0.00%
0/74 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
|
Skin and subcutaneous tissue disorders
Unexpected
|
0.00%
0/343 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
0.29%
1/344 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
0.00%
0/347 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
0.00%
0/104 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
0.00%
0/242 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
0.00%
0/244 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
0.00%
0/248 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
0.00%
0/74 • Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place