Trial Outcomes & Findings for In-vivo Efficacy Study of Patient Pre-operative Preps (NCT NCT01968707)
NCT ID: NCT01968707
Last Updated: 2024-10-02
Results Overview
On the abdominal region a responder was a subject with a 2 log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora did not return to baseline. On the inguinal region a responder was a subject with a 3 log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora did not return to baseline.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
426 participants
Primary outcome timeframe
baseline, 10 minutes post-product application and 6 hour post-product application
Results posted on
2024-10-02
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 sites, left \& right and/or 2 inguen test sites, left \& right. 406 subjects were randomized for the abdomen region \& 391 subjects randomized for the inguen region resulting in 426 subjects providing 1594 applications of test products on 2 anatomical regions.
Unit of analysis: test sites on skin
Participant milestones
| Measure |
ChloraPrep Hi-Lite Orange - 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 Tint 10.5-mL - Abdominal
Applied topically to the abdominal region for 30 seconds.
|
3M CHG/IPA Prep Tint 26-mL - Abdominal
Applied topically to the abdominal region for 30 seconds.
|
ChloraPrep Hi-Lite Orange - 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 Tint 10.5-mL - Inguinal
Applied topically to the inguinal region for 2 minutes.
|
3M CHG/IPA Prep Tint 26-mL - Inguinal
Applied topically to the inguinal region for 2 minutes.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
247 247
|
74 74
|
246 246
|
245 245
|
236 236
|
70 70
|
238 238
|
238 238
|
|
Overall Study
COMPLETED
|
198 198
|
62 62
|
205 205
|
201 201
|
200 200
|
59 59
|
204 204
|
203 203
|
|
Overall Study
NOT COMPLETED
|
49 49
|
12 12
|
41 41
|
44 44
|
36 36
|
11 11
|
34 34
|
35 35
|
Reasons for withdrawal
| Measure |
ChloraPrep Hi-Lite Orange - 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 Tint 10.5-mL - Abdominal
Applied topically to the abdominal region for 30 seconds.
|
3M CHG/IPA Prep Tint 26-mL - Abdominal
Applied topically to the abdominal region for 30 seconds.
|
ChloraPrep Hi-Lite Orange - 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 Tint 10.5-mL - Inguinal
Applied topically to the inguinal region for 2 minutes.
|
3M CHG/IPA Prep Tint 26-mL - Inguinal
Applied topically to the inguinal region for 2 minutes.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Did not meet treatment day baseline
|
49
|
12
|
41
|
44
|
36
|
11
|
34
|
35
|
Baseline Characteristics
In-vivo Efficacy Study of Patient Pre-operative Preps
Baseline characteristics by cohort
| Measure |
ChloraPrep Hi-Lite Orange - Abdominal
n=247 Test sites on skin
ChloraPrep 2% CHG/70% IPA 26-mL applicator applied topically for 30 seconds.
|
Normal Saline - Abdominal
n=74 Test sites on skin
Normal Saline with applicator applied topically for 30 seconds.
|
3M CHG/IPA Prep Tint 10.5-mL - Abdominal
n=246 Test sites on skin
3M CHG/IPA 2% CHG/70% IPA 10.5-mL applicator applied topically for 30 seconds.
|
3M CHG/IPA Prep Tint 26-mL - Abdominal
n=245 Test sites on skin
3M CHG/IPA 2% CHG/70% IPA 26-mL applicator applied topically for 30 seconds.
|
ChloraPrep Hi-Lite Orange - Inguinal
n=236 Test sites on skin
ChloraPrep 2% CHG/70% IPA 26-mL applicator applied topically for 2 minutes.
|
Normal Saline - Inguinal
n=70 Test sites on skin
Normal Saline with applicator applied topically for 2 minutes.
|
3M CHG/IPA Prep Tint 10.5-mL - Inguinal
n=238 Test sites on skin
3M CHG/IPA 2% CHG/70% IPA 10.5-mL applicator applied topically for 2 minutes.
|
3M CHG/IPA Prep 26-mL - Inguinal
n=238 Test sites on skin
3M CHG/IPA 2% CHG/70% IPA 26-mL applicator applied topically for 2 minutes.
|
Total
n=1594 Test sites on skin
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
<=18 years
|
247 participants
n=135 Test sites on skin
|
74 participants
n=135 Test sites on skin
|
246 participants
n=38 Test sites on skin
|
246 participants
n=308 Test sites on skin
|
236 participants
n=236 Test sites on skin
|
70 participants
n=70 Test sites on skin
|
238 participants
n=238 Test sites on skin
|
238 participants
n=238 Test sites on skin
|
0 participants
n=1594 Test sites on skin
|
|
Age, Customized
Between 18 and 65 years
|
247 participants
n=135 Test sites on skin
|
74 participants
n=135 Test sites on skin
|
246 participants
n=38 Test sites on skin
|
246 participants
n=308 Test sites on skin
|
236 participants
n=236 Test sites on skin
|
70 participants
n=70 Test sites on skin
|
238 participants
n=238 Test sites on skin
|
238 participants
n=238 Test sites on skin
|
409 participants
n=1594 Test sites on skin
|
|
Age, Customized
>=65 years
|
247 participants
n=135 Test sites on skin
|
74 participants
n=135 Test sites on skin
|
246 participants
n=38 Test sites on skin
|
245 participants
n=308 Test sites on skin
|
236 participants
n=96 Test sites on skin
|
70 participants
n=70 Test sites on skin
|
238 participants
n=238 Test sites on skin
|
238 participants
n=238 Test sites on skin
|
17 participants
n=1594 Test sites on skin
|
|
Sex/Gender, Customized
Female
|
247 participants
n=135 Test sites on skin
|
74 participants
n=135 Test sites on skin
|
246 participants
n=38 Test sites on skin
|
245 participants
n=308 Test sites on skin
|
236 participants
n=96 Test sites on skin
|
70 participants
n=70 Test sites on skin
|
238 participants
n=238 Test sites on skin
|
238 participants
n=238 Test sites on skin
|
213 participants
n=1594 Test sites on skin
|
|
Sex/Gender, Customized
Male
|
247 participants
n=135 Test sites on skin
|
74 participants
n=135 Test sites on skin
|
246 participants
n=38 Test sites on skin
|
245 participants
n=23 Test sites on skin
|
236 participants
n=96 Test sites on skin
|
70 participants
n=70 Test sites on skin
|
238 participants
n=238 Test sites on skin
|
238 participants
n=238 Test sites on skin
|
213 participants
n=1594 Test sites on skin
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
247 participants
n=135 Test sites on skin
|
74 participants
n=135 Test sites on skin
|
246 participants
n=38 Test sites on skin
|
245 participants
n=308 Test sites on skin
|
236 participants
n=96 Test sites on skin
|
70 participants
n=70 Test sites on skin
|
238 participants
n=238 Test sites on skin
|
238 participants
n=238 Test sites on skin
|
2 participants
n=1594 Test sites on skin
|
|
Race/Ethnicity, Customized
Asian
|
247 participants
n=135 Test sites on skin
|
74 participants
n=135 Test sites on skin
|
246 participants
n=38 Test sites on skin
|
245 participants
n=308 Test sites on skin
|
236 participants
n=96 Test sites on skin
|
70 participants
n=70 Test sites on skin
|
238 participants
n=238 Test sites on skin
|
238 participants
n=238 Test sites on skin
|
136 participants
n=1594 Test sites on skin
|
|
Race/Ethnicity, Customized
Black or African American
|
247 participants
n=135 Test sites on skin
|
74 participants
n=135 Test sites on skin
|
246 participants
n=38 Test sites on skin
|
245 participants
n=308 Test sites on skin
|
236 participants
n=96 Test sites on skin
|
70 participants
n=70 Test sites on skin
|
238 participants
n=238 Test sites on skin
|
238 participants
n=238 Test sites on skin
|
70 participants
n=1594 Test sites on skin
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
247 participants
n=135 Test sites on skin
|
74 participants
n=135 Test sites on skin
|
246 participants
n=38 Test sites on skin
|
245 participants
n=308 Test sites on skin
|
236 participants
n=236 Test sites on skin
|
70 participants
n=70 Test sites on skin
|
238 participants
n=238 Test sites on skin
|
238 participants
n=238 Test sites on skin
|
49 participants
n=1594 Test sites on skin
|
|
Race/Ethnicity, Customized
Native Hawiian or Other Pacific Islander
|
247 participants
n=135 Test sites on skin
|
74 participants
n=135 Test sites on skin
|
246 participants
n=38 Test sites on skin
|
245 participants
n=23 Test sites on skin
|
236 participants
n=96 Test sites on skin
|
70 participants
n=70 Test sites on skin
|
238 participants
n=238 Test sites on skin
|
238 participants
n=238 Test sites on skin
|
2 participants
n=1594 Test sites on skin
|
|
Race/Ethnicity, Customized
White
|
247 participants
n=135 Test sites on skin
|
74 participants
n=135 Test sites on skin
|
246 participants
n=38 Test sites on skin
|
245 participants
n=308 Test sites on skin
|
236 participants
n=96 Test sites on skin
|
70 participants
n=70 Test sites on skin
|
237 participants
n=238 Test sites on skin
|
238 participants
n=238 Test sites on skin
|
160 participants
n=1594 Test sites on skin
|
|
Race/Ethnicity, Customized
Other
|
247 participants
n=135 Test sites on skin
|
74 participants
n=135 Test sites on skin
|
246 participants
n=38 Test sites on skin
|
245 participants
n=308 Test sites on skin
|
236 participants
n=96 Test sites on skin
|
70 participants
n=70 Test sites on skin
|
238 participants
n=238 Test sites on skin
|
238 participants
n=238 Test sites on skin
|
7 participants
n=1594 Test sites on skin
|
|
Region of Enrollment
United States
|
247 participants
n=135 Test sites on skin
|
74 participants
n=135 Test sites on skin
|
246 participants
n=38 Test sites on skin
|
245 participants
n=308 Test sites on skin
|
236 participants
n=96 Test sites on skin
|
70 participants
n=70 Test sites on skin
|
238 participants
n=238 Test sites on skin
|
238 participants
n=238 Test sites on skin
|
426 participants
n=1594 Test sites on skin
|
PRIMARY outcome
Timeframe: baseline, 10 minutes post-product application and 6 hour post-product applicationPopulation: 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 on the abdomen test site or 5.0 log10 on the inguinal test site.
On the abdominal region a responder was a subject with a 2 log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora did not return to baseline. On the inguinal region a responder was a subject with a 3 log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora did not return to baseline.
Outcome measures
| Measure |
ChloraPrep Hi-Lite Orange - Abdominal
n=198 Participants
Applied topically to the abdominal region for 30 seconds.
|
3M CHG/IPA Prep Tint 10.5-mL - Abdominal
n=205 Participants
Applied topically to the abdominal region for 30 seconds.
|
3M CHG/IPA Prep Tint 26-mL - Abdominal
n=201 Participants
Applied topically to the abdominal region for 30 seconds.
|
Normal Saline - Abdominal
n=62 Participants
Apply topically to the abdominal region for 30 seconds
|
ChloraPrep Hi-Lite Orange - Inguinal
n=200 Participants
Applied topically to the inguinal region for 2 minutes.
|
3M CHG/IPA Prep Tint 10.5-mL - Inguinal
n=204 Participants
Applied topically to the inguinal region for 2 minutes.
|
3M CHG/IPA Prep Tint 26-mL - Inguinal
n=203 Participants
Applied topically to the inguinal region for 2 minutes
|
Normal Saline - Inguinal
n=59 Participants
Apply topically to the inguinal region for 2 minutes
|
|---|---|---|---|---|---|---|---|---|
|
Responder Rate
|
178 Participants
|
167 Participants
|
175 Participants
|
0 Participants
|
168 Participants
|
168 Participants
|
162 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 6 hoursPopulation: 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 on the abdomen test site or 5.0 log10 on the inguinal test site.
log10/cm2 reduction of skin flora, relative to treatment day baseline (log10/cm2), at 6 hours post-treatment
Outcome measures
| Measure |
ChloraPrep Hi-Lite Orange - Abdominal
n=198 Participants
Applied topically to the abdominal region for 30 seconds.
|
3M CHG/IPA Prep Tint 10.5-mL - Abdominal
n=62 Participants
Applied topically to the abdominal region for 30 seconds.
|
3M CHG/IPA Prep Tint 26-mL - Abdominal
n=205 Participants
Applied topically to the abdominal region for 30 seconds.
|
Normal Saline - Abdominal
n=201 Participants
Apply topically to the abdominal region for 30 seconds
|
ChloraPrep Hi-Lite Orange - Inguinal
n=200 Participants
Applied topically to the inguinal region for 2 minutes.
|
3M CHG/IPA Prep Tint 10.5-mL - Inguinal
n=59 Participants
Applied topically to the inguinal region for 2 minutes.
|
3M CHG/IPA Prep Tint 26-mL - Inguinal
n=204 Participants
Applied topically to the inguinal region for 2 minutes
|
Normal Saline - Inguinal
n=203 Participants
Apply topically to the inguinal region for 2 minutes
|
|---|---|---|---|---|---|---|---|---|
|
Reduction of Skin Flora 6 Hours Post-treatment
|
1.77 log10/cm2
Standard Deviation 0.899
|
0.47 log10/cm2
Standard Deviation 0.651
|
1.48 log10/cm2
Standard Deviation 0.866
|
1.64 log10/cm2
Standard Deviation 0.864
|
2.64 log10/cm2
Standard Deviation 1.047
|
1.08 log10/cm2
Standard Deviation 0.833
|
2.24 log10/cm2
Standard Deviation 1.103
|
2.35 log10/cm2
Standard Deviation 1.045
|
SECONDARY outcome
Timeframe: 10 minutesPopulation: 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 on the abdomen test site or 5.0 log10 on the inguinal test site.
log10/cm2 reduction of skin flora, relative to treatment day baseline (log10/cm2), at 10 minutes post-treatment
Outcome measures
| Measure |
ChloraPrep Hi-Lite Orange - Abdominal
n=198 Participants
Applied topically to the abdominal region for 30 seconds.
|
3M CHG/IPA Prep Tint 10.5-mL - Abdominal
n=62 Participants
Applied topically to the abdominal region for 30 seconds.
|
3M CHG/IPA Prep Tint 26-mL - Abdominal
n=205 Participants
Applied topically to the abdominal region for 30 seconds.
|
Normal Saline - Abdominal
n=201 Participants
Apply topically to the abdominal region for 30 seconds
|
ChloraPrep Hi-Lite Orange - Inguinal
n=200 Participants
Applied topically to the inguinal region for 2 minutes.
|
3M CHG/IPA Prep Tint 10.5-mL - Inguinal
n=59 Participants
Applied topically to the inguinal region for 2 minutes.
|
3M CHG/IPA Prep Tint 26-mL - Inguinal
n=204 Participants
Applied topically to the inguinal region for 2 minutes
|
Normal Saline - Inguinal
n=203 Participants
Apply topically to the inguinal region for 2 minutes
|
|---|---|---|---|---|---|---|---|---|
|
Reduction of Skin Flora 10 Minutes Post-treatment
|
2.79 log10/cm2
Standard Deviation 0.565
|
0.64 log10/cm2
Standard Deviation 0.488
|
2.66 log10/cm2
Standard Deviation 0.706
|
2.74 log10/cm2
Standard Deviation 0.644
|
4.04 log10/cm2
Standard Deviation 0.964
|
1.34 log10/cm2
Standard Deviation 1.096
|
3.98 log10/cm2
Standard Deviation 1.034
|
3.89 log10/cm2
Standard Deviation 0.929
|
SECONDARY outcome
Timeframe: 6 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 on the abdomen test site or 5.0 log10 on the inguinal test site.
Log10/cm2 recovery of skin flora at 6 hours following application of study treatment
Outcome measures
| Measure |
ChloraPrep Hi-Lite Orange - Abdominal
n=198 Participants
Applied topically to the abdominal region for 30 seconds.
|
3M CHG/IPA Prep Tint 10.5-mL - Abdominal
n=62 Participants
Applied topically to the abdominal region for 30 seconds.
|
3M CHG/IPA Prep Tint 26-mL - Abdominal
n=205 Participants
Applied topically to the abdominal region for 30 seconds.
|
Normal Saline - Abdominal
n=201 Participants
Apply topically to the abdominal region for 30 seconds
|
ChloraPrep Hi-Lite Orange - Inguinal
n=200 Participants
Applied topically to the inguinal region for 2 minutes.
|
3M CHG/IPA Prep Tint 10.5-mL - Inguinal
n=59 Participants
Applied topically to the inguinal region for 2 minutes.
|
3M CHG/IPA Prep Tint 26-mL - Inguinal
n=204 Participants
Applied topically to the inguinal region for 2 minutes
|
Normal Saline - Inguinal
n=203 Participants
Apply topically to the inguinal region for 2 minutes
|
|---|---|---|---|---|---|---|---|---|
|
Skin Flora Recovery 6-hours Post-treatment
|
1.54 log10/cm2 skin flora
Standard Deviation 0.808
|
2.80 log10/cm2 skin flora
Standard Deviation 0.726
|
1.87 log10/cm2 skin flora
Standard Deviation 0.804
|
1.66 log10/cm2 skin flora
Standard Deviation 0.803
|
2.81 log10/cm2 skin flora
Standard Deviation 1.008
|
4.31 log10/cm2 skin flora
Standard Deviation 0.941
|
3.20 log10/cm2 skin flora
Standard Deviation 1.037
|
3.07 log10/cm2 skin flora
Standard Deviation 1.032
|
SECONDARY outcome
Timeframe: 10 minutes 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 on the abdomen test site or 5.0 log10 on the inguinal test site.
Log10/cm2 recovery of skin flora at 10 minutes following application of study treatments
Outcome measures
| Measure |
ChloraPrep Hi-Lite Orange - Abdominal
n=198 Participants
Applied topically to the abdominal region for 30 seconds.
|
3M CHG/IPA Prep Tint 10.5-mL - Abdominal
n=62 Participants
Applied topically to the abdominal region for 30 seconds.
|
3M CHG/IPA Prep Tint 26-mL - Abdominal
n=205 Participants
Applied topically to the abdominal region for 30 seconds.
|
Normal Saline - Abdominal
n=201 Participants
Apply topically to the abdominal region for 30 seconds
|
ChloraPrep Hi-Lite Orange - Inguinal
n=200 Participants
Applied topically to the inguinal region for 2 minutes.
|
3M CHG/IPA Prep Tint 10.5-mL - Inguinal
n=59 Participants
Applied topically to the inguinal region for 2 minutes.
|
3M CHG/IPA Prep Tint 26-mL - Inguinal
n=204 Participants
Applied topically to the inguinal region for 2 minutes
|
Normal Saline - Inguinal
n=203 Participants
Apply topically to the inguinal region for 2 minutes
|
|---|---|---|---|---|---|---|---|---|
|
Skin Flora Recovery 10 Minutes Post-treatment
|
0.52 log10/cm2 skin flora
Standard Deviation 0.500
|
2.63 log10/cm2 skin flora
Standard Deviation 0.582
|
0.69 log10/cm2 skin flora
Standard Deviation 0.604
|
0.57 log10/cm2 skin flora
Standard Deviation 0.575
|
1.41 log10/cm2 skin flora
Standard Deviation 1.089
|
4.06 log10/cm2 skin flora
Standard Deviation 1.211
|
1.47 log10/cm2 skin flora
Standard Deviation 1.120
|
1.53 log10/cm2 skin flora
Standard Deviation 1.039
|
SECONDARY outcome
Timeframe: BaselinePopulation: 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 on the abdomen test site or 5.0 log10 on the inguinal test site.
Log10/cm2 baseline skin flora for abdominal and inguinal regions
Outcome measures
| Measure |
ChloraPrep Hi-Lite Orange - Abdominal
n=198 Participants
Applied topically to the abdominal region for 30 seconds.
|
3M CHG/IPA Prep Tint 10.5-mL - Abdominal
n=62 Participants
Applied topically to the abdominal region for 30 seconds.
|
3M CHG/IPA Prep Tint 26-mL - Abdominal
n=205 Participants
Applied topically to the abdominal region for 30 seconds.
|
Normal Saline - Abdominal
n=201 Participants
Apply topically to the abdominal region for 30 seconds
|
ChloraPrep Hi-Lite Orange - Inguinal
n=200 Participants
Applied topically to the inguinal region for 2 minutes.
|
3M CHG/IPA Prep Tint 10.5-mL - Inguinal
n=59 Participants
Applied topically to the inguinal region for 2 minutes.
|
3M CHG/IPA Prep Tint 26-mL - Inguinal
n=204 Participants
Applied topically to the inguinal region for 2 minutes
|
Normal Saline - Inguinal
n=203 Participants
Apply topically to the inguinal region for 2 minutes
|
|---|---|---|---|---|---|---|---|---|
|
Skin Flora Baseline for the Abdominal and Inguinal Region.
|
3.31 log10/cm2 skin flora
Standard Deviation 0.391
|
3.27 log10/cm2 skin flora
Standard Deviation 0.342
|
3.35 log10/cm2 skin flora
Standard Deviation 0.427
|
3.31 log10/cm2 skin flora
Standard Deviation 0.370
|
5.44 log10/cm2 skin flora
Standard Deviation 0.479
|
5.40 log10/cm2 skin flora
Standard Deviation 0.448
|
5.44 log10/cm2 skin flora
Standard Deviation 0.490
|
5.42 log10/cm2 skin flora
Standard Deviation 0.469
|
SECONDARY outcome
Timeframe: Assessed at baseline (pre-treatment) and 10 minute post-treatment and 6 hour post-treatment.Population: 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=moderated, 3=severe
Outcome measures
| Measure |
ChloraPrep Hi-Lite Orange - Abdominal
n=247 Participants
Applied topically to the abdominal region for 30 seconds.
|
3M CHG/IPA Prep Tint 10.5-mL - Abdominal
n=74 Participants
Applied topically to the abdominal region for 30 seconds.
|
3M CHG/IPA Prep Tint 26-mL - Abdominal
n=246 Participants
Applied topically to the abdominal region for 30 seconds.
|
Normal Saline - Abdominal
n=245 Participants
Apply topically to the abdominal region for 30 seconds
|
ChloraPrep Hi-Lite Orange - Inguinal
n=236 Participants
Applied topically to the inguinal region for 2 minutes.
|
3M CHG/IPA Prep Tint 10.5-mL - Inguinal
n=70 Participants
Applied topically to the inguinal region for 2 minutes.
|
3M CHG/IPA Prep Tint 26-mL - Inguinal
n=238 Participants
Applied topically to the inguinal region for 2 minutes
|
Normal Saline - Inguinal
n=238 Participants
Apply topically to the inguinal region for 2 minutes
|
|---|---|---|---|---|---|---|---|---|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Baseline Erythema-Mild (1)
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Baseline Erythema-Moderate (2)
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Baseline Erythema-Severe (3)
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
10 minute Edema-No Reaction (0)
|
247 test sites on skin
|
74 test sites on skin
|
246 test sites on skin
|
245 test sites on skin
|
236 test sites on skin
|
70 test sites on skin
|
238 test sites on skin
|
238 test sites on skin
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
10 minute Edema-Mild (1)
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Baseline Dryness-No Reaction (0)
|
247 test sites on skin
|
74 test sites on skin
|
246 test sites on skin
|
245 test sites on skin
|
236 test sites on skin
|
70 test sites on skin
|
238 test sites on skin
|
238 test sites on skin
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Baseline Dryness-Mild (1)
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Baseline Dryness-Moderate (2)
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Baseline Dryness-Severe (3)
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Baseline Edema-No Reaction (0)
|
247 test sites on skin
|
74 test sites on skin
|
246 test sites on skin
|
245 test sites on skin
|
236 test sites on skin
|
70 test sites on skin
|
238 test sites on skin
|
238 test sites on skin
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Baseline Edema-Mild (1)
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Baseline Edema-Moderate (2)
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Baseline Edema-Severe (3)
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Baseline Erythema-No Reaction (0)
|
247 test sites on skin
|
74 test sites on skin
|
246 test sites on skin
|
245 test sites on skin
|
236 test sites on skin
|
70 test sites on skin
|
238 test sites on skin
|
238 test sites on skin
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Baseline Rash-No Reaction (0)
|
247 test sites on skin
|
74 test sites on skin
|
246 test sites on skin
|
245 test sites on skin
|
236 test sites on skin
|
70 test sites on skin
|
238 test sites on skin
|
238 test sites on skin
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Baseline Rash-Mild (1)
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Baseline Rash-Moderate (2)
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
Baseline Rash-Severe (3)
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
10 minute Dryness-No Reaction (0)
|
247 test sites on skin
|
74 test sites on skin
|
246 test sites on skin
|
245 test sites on skin
|
236 test sites on skin
|
70 test sites on skin
|
238 test sites on skin
|
238 test sites on skin
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
10 minute Dryness-Mild (1)
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
10 minute Dryness-Moderate (2)
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
10 minute Dryness-Severe (3)
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
6 hour Rash-Severe (3)
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
10 minute Edema-Moderate (2)
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
10 minute Edema-Severe (3)
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
10 minute Erythema-No Reaction (0)
|
247 test sites on skin
|
74 test sites on skin
|
246 test sites on skin
|
245 test sites on skin
|
236 test sites on skin
|
70 test sites on skin
|
238 test sites on skin
|
238 test sites on skin
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
10 minute Erythema-Mild (1)
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
10 minute Erythema-Moderate (2)
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
10 minute Erythema-Severe (3)
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
10 minute Rash-No Reaction (0)
|
247 test sites on skin
|
74 test sites on skin
|
246 test sites on skin
|
245 test sites on skin
|
236 test sites on skin
|
70 test sites on skin
|
238 test sites on skin
|
238 test sites on skin
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
10 minute Rash-Mild (1)
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
10 minute Rash-Mild (2)
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
10 minute Rash-Severe (3)
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
6 hour Dryness-No Reaction (0)
|
247 test sites on skin
|
74 test sites on skin
|
246 test sites on skin
|
245 test sites on skin
|
236 test sites on skin
|
70 test sites on skin
|
238 test sites on skin
|
238 test sites on skin
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
6 hour Dryness-Mild (1)
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
6 hour Dryness-Moderate (2)
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
6 hour Dryness-Severe (3)
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
6 hour Edema-No Reaction (0)
|
247 test sites on skin
|
74 test sites on skin
|
246 test sites on skin
|
245 test sites on skin
|
236 test sites on skin
|
70 test sites on skin
|
238 test sites on skin
|
238 test sites on skin
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
6 hour Edema-Mild (1)
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
6 hour Edema-Moderate (2)
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
6 hour Edema-Severe (3)
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
6 hour Erythema-No Reaction (0)
|
247 test sites on skin
|
74 test sites on skin
|
246 test sites on skin
|
245 test sites on skin
|
236 test sites on skin
|
70 test sites on skin
|
238 test sites on skin
|
238 test sites on skin
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
6 hour Erythema-Mild (1)
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
6 hour Erythema-Moderate (2)
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
6 hour Erythema-Severe (3)
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
6 hour Rash-No Reaction (0)
|
247 test sites on skin
|
74 test sites on skin
|
246 test sites on skin
|
245 test sites on skin
|
236 test sites on skin
|
70 test sites on skin
|
238 test sites on skin
|
238 test sites on skin
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
6 hour Rash-Mild (1)
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
|
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
6 hour Rash-Moderate (2)
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
0 test sites on skin
|
Adverse Events
ChloraPrep Hi-Lite Orange - Abdominal
Serious events: 0 serious events
Other events: 0 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 Tint 10.5-mL - Abdominal
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
3M CHG/IPA Prep Tint 26-mL - Abdominal
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ChloraPrep Hi-Lite Orange - 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
3M CHG/IPA Prep Tint 10.5-mL - Inguinal
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
3M CHG/IPA Prep Tint 26-mL - 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