Trial Outcomes & Findings for In-vivo Efficacy Study of Patient Preoperative Preps (NCT NCT01968356)
NCT ID: NCT01968356
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 at 6 hours. 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 at 6 hours.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
171 participants
Primary outcome timeframe
baseline, 10 minute 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 and one on the right. Each subject provided 2 abdomen test sites, left \& right and/or 2 inguen test sites, left \& right. 161 subjects were randomized for the abdomen region \& 162 subjects randomized for the inguen region, resulting in 171 subjects providing 646 applications of test products on 2 anatomical regions.
Unit of analysis: test sites on skin
Participant milestones
| Measure |
3M CHG/IPA Prep Colorless Abdominal Region
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator
3M CHG/IPA Prep Colorless: Apply topically.
|
3M CHG/IPA Prep Tint Abdominal Region
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator
3M CHG/IPA Prep Tint: Apply topically.
|
ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator
ChloraPrep CHG/IPA Hi-Lite Orange Tint: Apply topically.
|
Normal Saline Abdominal Region
0.9% normal saline with applicator
Normal Saline: Apply topically.
|
3M CHG/IPA Prep Colorless Inguinal Region
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator
3M CHG/IPA Prep Colorless: Apply topically.
|
3M CHG/IPA Prep Tint Inguinal Region
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator
3M CHG/IPA Prep Colorless: Apply topically.
|
ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator
ChloraPrep CHG/IPA Hi-Lite Orange Tint: Apply topically.
|
Normal Saline Inguinal Region
0.9% normal saline with applicator
Normal Saline: Apply topically.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
101 101
|
93 93
|
96 96
|
32 32
|
97 97
|
99 99
|
97 97
|
31 31
|
|
Overall Study
COMPLETED
|
101 101
|
93 93
|
96 96
|
32 32
|
97 97
|
99 99
|
97 97
|
31 31
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
In-vivo Efficacy Study of Patient Preoperative Preps
Baseline characteristics by cohort
| Measure |
3M CHG/IPA Prep Colorless Abdominal Region
n=101 test sites on skin
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator
3M CHG/IPA Prep Colorless: Apply topically.
|
3M CHG/IPA Prep Tint Abdominal Region
n=93 test sites on skin
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator
3M CHG/IPA Prep Tint: Apply topically.
|
ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region
n=96 test sites on skin
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator
ChloraPrep CHG/IPA Hi-Lite Orange Tint: Apply topically.
|
Normal Saline Abdominal Region
n=32 test sites on skin
0.9% normal saline with applicator
Normal Saline: Apply topically.
|
3M CHG/IPA Prep Colorless Inguinal Region
n=97 test sites on skin
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator
3M CHG/IPA Prep Colorless: Apply topically.
|
3M CHG/IPA Prep Tint Inguinal Region
n=99 test sites on skin
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator
3M CHG/IPA Prep Colorless: Apply topically.
|
ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region
n=97 test sites on skin
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator
ChloraPrep CHG/IPA Hi-Lite Orange Tint: Apply topically.
|
Normal Saline Inguinal Region
n=31 test sites on skin
0.9% normal saline with applicator
Normal Saline: Apply topically.
|
Total
n=646 test sites on skin
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
2 test sites on skin
n=343 test sites on skin
|
2 test sites on skin
n=344 test sites on skin
|
3 test sites on skin
n=347 test sites on skin
|
1 test sites on skin
n=104 test sites on skin
|
2 test sites on skin
n=242 test sites on skin
|
3 test sites on skin
n=99 test sites on skin
|
3 test sites on skin
n=97 test sites on skin
|
2 test sites on skin
n=74 test sites on skin
|
18 test sites on skin
n=646 test sites on skin
|
|
Sex/Gender, Customized
Sex : Male
|
78 test sites on skin
n=343 test sites on skin
|
65 test sites on skin
n=344 test sites on skin
|
69 test sites on skin
n=347 test sites on skin
|
25 test sites on skin
n=69 test sites on skin
|
66 test sites on skin
n=242 test sites on skin
|
77 test sites on skin
n=244 test sites on skin
|
76 test sites on skin
n=248 test sites on skin
|
20 test sites on skin
n=31 test sites on skin
|
476 test sites on skin
n=1946 test sites on skin
|
|
Race/Ethnicity, Customized
White
|
88 test sites on skin
n=343 test sites on skin
|
86 test sites on skin
n=344 test sites on skin
|
80 test sites on skin
n=347 test sites on skin
|
28 test sites on skin
n=69 test sites on skin
|
84 test sites on skin
n=276 test sites on skin
|
88 test sites on skin
n=99 test sites on skin
|
85 test sites on skin
n=97 test sites on skin
|
25 test sites on skin
n=74 test sites on skin
|
564 test sites on skin
n=1946 test sites on skin
|
|
Age, Customized
<=18 years
|
0 test sites on skin
n=343 test sites on skin
|
0 test sites on skin
n=344 test sites on skin
|
0 test sites on skin
n=347 test sites on skin
|
0 test sites on skin
n=104 test sites on skin
|
0 test sites on skin
n=276 test sites on skin
|
0 test sites on skin
n=244 test sites on skin
|
0 test sites on skin
n=248 test sites on skin
|
0 test sites on skin
n=74 test sites on skin
|
0 test sites on skin
n=1946 test sites on skin
|
|
Age, Customized
Between 18 and 65 years
|
99 test sites on skin
n=343 test sites on skin
|
92 test sites on skin
n=344 test sites on skin
|
94 test sites on skin
n=347 test sites on skin
|
31 test sites on skin
n=104 test sites on skin
|
96 test sites on skin
n=276 test sites on skin
|
96 test sites on skin
n=244 test sites on skin
|
95 test sites on skin
n=248 test sites on skin
|
31 test sites on skin
n=31 test sites on skin
|
634 test sites on skin
n=646 test sites on skin
|
|
Age, Customized
>=66 years
|
2 test sites on skin
n=343 test sites on skin
|
1 test sites on skin
n=344 test sites on skin
|
2 test sites on skin
n=347 test sites on skin
|
1 test sites on skin
n=69 test sites on skin
|
1 test sites on skin
n=242 test sites on skin
|
3 test sites on skin
n=244 test sites on skin
|
2 test sites on skin
n=97 test sites on skin
|
0 test sites on skin
n=74 test sites on skin
|
12 test sites on skin
n=646 test sites on skin
|
|
Sex/Gender, Customized
Sex : Female
|
23 test sites on skin
n=343 test sites on skin
|
28 test sites on skin
n=344 test sites on skin
|
27 test sites on skin
n=347 test sites on skin
|
7 test sites on skin
n=104 test sites on skin
|
31 test sites on skin
n=276 test sites on skin
|
22 test sites on skin
n=99 test sites on skin
|
21 test sites on skin
n=97 test sites on skin
|
11 test sites on skin
n=74 test sites on skin
|
170 test sites on skin
n=1946 test sites on skin
|
|
Race/Ethnicity, Customized
Black or Africian American
|
3 test sites on skin
n=343 test sites on skin
|
0 test sites on skin
n=344 test sites on skin
|
3 test sites on skin
n=347 test sites on skin
|
0 test sites on skin
n=104 test sites on skin
|
1 test sites on skin
n=242 test sites on skin
|
2 test sites on skin
n=244 test sites on skin
|
2 test sites on skin
n=248 test sites on skin
|
1 test sites on skin
n=31 test sites on skin
|
12 test sites on skin
n=646 test sites on skin
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
1 test sites on skin
n=343 test sites on skin
|
1 test sites on skin
n=344 test sites on skin
|
1 test sites on skin
n=347 test sites on skin
|
1 test sites on skin
n=69 test sites on skin
|
2 test sites on skin
n=242 test sites on skin
|
1 test sites on skin
n=99 test sites on skin
|
1 test sites on skin
n=97 test sites on skin
|
0 test sites on skin
n=31 test sites on skin
|
8 test sites on skin
n=1946 test sites on skin
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
4 test sites on skin
n=343 test sites on skin
|
1 test sites on skin
n=344 test sites on skin
|
4 test sites on skin
n=347 test sites on skin
|
1 test sites on skin
n=69 test sites on skin
|
4 test sites on skin
n=242 test sites on skin
|
4 test sites on skin
n=99 test sites on skin
|
3 test sites on skin
n=248 test sites on skin
|
1 test sites on skin
n=31 test sites on skin
|
22 test sites on skin
n=646 test sites on skin
|
|
Race/Ethnicity, Customized
Asian
|
2 test sites on skin
n=343 test sites on skin
|
1 test sites on skin
n=344 test sites on skin
|
3 test sites on skin
n=347 test sites on skin
|
0 test sites on skin
n=104 test sites on skin
|
3 test sites on skin
n=242 test sites on skin
|
1 test sites on skin
n=244 test sites on skin
|
1 test sites on skin
n=248 test sites on skin
|
1 test sites on skin
n=31 test sites on skin
|
12 test sites on skin
n=646 test sites on skin
|
|
Race/Ethnicity, Customized
Other
|
1 test sites on skin
n=343 test sites on skin
|
2 test sites on skin
n=344 test sites on skin
|
2 test sites on skin
n=347 test sites on skin
|
1 test sites on skin
n=69 test sites on skin
|
1 test sites on skin
n=276 test sites on skin
|
0 test sites on skin
n=99 test sites on skin
|
2 test sites on skin
n=248 test sites on skin
|
1 test sites on skin
n=31 test sites on skin
|
10 test sites on skin
n=646 test sites on skin
|
PRIMARY outcome
Timeframe: baseline, 10 minute post-product application and 6 hour post-product applicationPopulation: This study was discontinued prematurely due to technical and data quality issues. In agreement with the FDA no efficacy analysis was conducted. Thus, the efficacy objective of the study could not be evaluated.
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 at 6 hours. 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 at 6 hours.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: BaselinePopulation: This study was discontinued prematurely due to technical and data quality issues. In agreement with the FDA no efficacy analysis was conducted. Thus, the efficacy objective of the study could not be evaluated.
Log10/cm2 baseline skin flora for abdominal and inguinal regions
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 10 minutes and 6 hours post-treatmentPopulation: This study was discontinued prematurely due to technical and data quality issues. In agreement with the FDA no efficacy analysis was conducted. Thus, the efficacy objective of the study could not be evaluated.
Log10/cm2 recovery of skin flora at 10 minutes and 6 hours following application of study treatments for abdominal and inguinal regions
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline, 10 minutes and 6 hoursPopulation: This study was discontinued prematurely due to technical and data quality issues. In agreement with the FDA no efficacy analysis was conducted. Thus, the efficacy objective of the study could not be evaluated.
Log10/cm2 reduction of skin flora, relative to Treatment Day baseline log10/cm2, at 10 minutes and 6 hours
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselinePopulation: \# of sites treated (met inclusion/exclusion criteria including screening day baseline counts)
Skin irritation rating (0-3) scores for dryness, edema, erythema and rash. 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe. A skin irritation rating of 3 in any category represents significant irritation and qualifies as an adverse event.
Outcome measures
| Measure |
3M CHG/IPA Prep Colorless Abdominal Region
n=101 Participants
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator
3M CHG/IPA Prep Colorless: Apply topically.
|
3M CHG/IPA Prep Tint Abdominal Region
n=93 Participants
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator
3M CHG/IPA Prep Tint: Apply topically.
|
ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region
n=96 Participants
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator
ChloraPrep CHG/IPA Hi-Lite Orange Tint: Apply topically.
|
Normal Saline Abdominal Region
n=32 Participants
0.9% normal saline with applicator
Normal Saline: Apply topically.
|
3M CHG/IPA Prep Colorless Inguinal Region
n=97 Participants
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator
3M CHG/IPA Prep Colorless: Apply topically.
|
3M CHG/IPA Prep Tint Inguinal Region
n=99 Participants
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator
3M CHG/IPA Prep Colorless: Apply topically.
|
ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region
n=97 Participants
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator
ChloraPrep CHG/IPA Hi-Lite Orange Tint: Apply topically.
|
Normal Saline Inguinal Region
n=31 Participants
0.9% normal saline with applicator
Normal Saline: Apply topically.
|
|---|---|---|---|---|---|---|---|---|
|
Safety as Assessed by Skin Irritation Scores
Dryness-Mild (1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Safety as Assessed by Skin Irritation Scores
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 Scores
Dryness-No reaction (0)
|
101 Participants
|
93 Participants
|
96 Participants
|
32 Participants
|
97 Participants
|
97 Participants
|
96 Participants
|
30 Participants
|
|
Safety as Assessed by Skin Irritation Scores
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 Scores
Edema-No reaction (0)
|
101 Participants
|
93 Participants
|
96 Participants
|
32 Participants
|
97 Participants
|
98 Participants
|
96 Participants
|
31 Participants
|
|
Safety as Assessed by Skin Irritation Scores
Edema-Mild (1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Safety as Assessed by Skin Irritation Scores
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 Scores
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 Scores
Erythema- No reaction (0)
|
99 Participants
|
90 Participants
|
96 Participants
|
31 Participants
|
97 Participants
|
97 Participants
|
96 Participants
|
30 Participants
|
|
Safety as Assessed by Skin Irritation Scores
Erythema-Mild (1)
|
2 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Safety as Assessed by Skin Irritation Scores
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 Scores
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 Scores
Rash-No Reaction (0)
|
101 Participants
|
93 Participants
|
96 Participants
|
32 Participants
|
97 Participants
|
97 Participants
|
96 Participants
|
30 Participants
|
|
Safety as Assessed by Skin Irritation Scores
Rash-Mild (1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Safety as Assessed by Skin Irritation Scores
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 Scores
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: \# of sites treated (met inclusion/exclusion criteria including screening day baseline counts
Skin irritation rating (0-3) scores for dryness, edema, erythema and rash. 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe. A skin irritation rating of 3 in any category represents significant irritation and qualifies as an adverse event.
Outcome measures
| Measure |
3M CHG/IPA Prep Colorless Abdominal Region
n=101 Participants
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator
3M CHG/IPA Prep Colorless: Apply topically.
|
3M CHG/IPA Prep Tint Abdominal Region
n=93 Participants
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator
3M CHG/IPA Prep Tint: Apply topically.
|
ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region
n=96 Participants
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator
ChloraPrep CHG/IPA Hi-Lite Orange Tint: Apply topically.
|
Normal Saline Abdominal Region
n=32 Participants
0.9% normal saline with applicator
Normal Saline: Apply topically.
|
3M CHG/IPA Prep Colorless Inguinal Region
n=97 Participants
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator
3M CHG/IPA Prep Colorless: Apply topically.
|
3M CHG/IPA Prep Tint Inguinal Region
n=99 Participants
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator
3M CHG/IPA Prep Colorless: Apply topically.
|
ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region
n=97 Participants
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator
ChloraPrep CHG/IPA Hi-Lite Orange Tint: Apply topically.
|
Normal Saline Inguinal Region
n=31 Participants
0.9% normal saline with applicator
Normal Saline: Apply topically.
|
|---|---|---|---|---|---|---|---|---|
|
Safety as Assessed by Skin Irritation Scores
Edema-Mild (1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Safety as Assessed by Skin Irritation Scores
Rash-Severe (3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety as Assessed by Skin Irritation Scores
Dryness-No Reaction (0)
|
101 Participants
|
93 Participants
|
96 Participants
|
32 Participants
|
97 Participants
|
97 Participants
|
96 Participants
|
30 Participants
|
|
Safety as Assessed by Skin Irritation Scores
Dryness-Mild (1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Safety as Assessed by Skin Irritation Scores
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 Scores
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 Scores
Edema-No Reaction (0)
|
101 Participants
|
93 Participants
|
96 Participants
|
32 Participants
|
97 Participants
|
98 Participants
|
96 Participants
|
31 Participants
|
|
Safety as Assessed by Skin Irritation Scores
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 Scores
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 Scores
Erythema-No Reaction (0)
|
98 Participants
|
91 Participants
|
96 Participants
|
31 Participants
|
96 Participants
|
97 Participants
|
96 Participants
|
30 Participants
|
|
Safety as Assessed by Skin Irritation Scores
Erythema-Mild (1)
|
3 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Safety as Assessed by Skin Irritation Scores
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 Scores
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 Scores
Rash-No Reaction (0)
|
101 Participants
|
93 Participants
|
96 Participants
|
32 Participants
|
96 Participants
|
97 Participants
|
96 Participants
|
30 Participants
|
|
Safety as Assessed by Skin Irritation Scores
Rash-Mild (1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Safety as Assessed by Skin Irritation Scores
Rash-Moderate (2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 hours post-treatmentPopulation: \# sites treated (met inclusion/exclusion criteria including screening day baseline counts)
Skin irritation rating (0-3) scores for dryness, edema, erythema and rash. 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe. A skin irritation rating of 3 in any category represents significant irritation and qualifies as an adverse event.
Outcome measures
| Measure |
3M CHG/IPA Prep Colorless Abdominal Region
n=101 Participants
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator
3M CHG/IPA Prep Colorless: Apply topically.
|
3M CHG/IPA Prep Tint Abdominal Region
n=93 Participants
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator
3M CHG/IPA Prep Tint: Apply topically.
|
ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region
n=96 Participants
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator
ChloraPrep CHG/IPA Hi-Lite Orange Tint: Apply topically.
|
Normal Saline Abdominal Region
n=32 Participants
0.9% normal saline with applicator
Normal Saline: Apply topically.
|
3M CHG/IPA Prep Colorless Inguinal Region
n=97 Participants
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator
3M CHG/IPA Prep Colorless: Apply topically.
|
3M CHG/IPA Prep Tint Inguinal Region
n=99 Participants
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator
3M CHG/IPA Prep Colorless: Apply topically.
|
ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region
n=97 Participants
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 10.5 mL applicator
ChloraPrep CHG/IPA Hi-Lite Orange Tint: Apply topically.
|
Normal Saline Inguinal Region
n=31 Participants
0.9% normal saline with applicator
Normal Saline: Apply topically.
|
|---|---|---|---|---|---|---|---|---|
|
Safety as Assessed by Skin Irritation Scores
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 Scores
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 Scores
Edema-No Reaction (0)
|
101 Participants
|
93 Participants
|
96 Participants
|
32 Participants
|
97 Participants
|
99 Participants
|
97 Participants
|
31 Participants
|
|
Safety as Assessed by Skin Irritation Scores
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 Scores
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 Scores
Erythema-No Reaction (0)
|
101 Participants
|
93 Participants
|
96 Participants
|
32 Participants
|
97 Participants
|
96 Participants
|
97 Participants
|
30 Participants
|
|
Safety as Assessed by Skin Irritation Scores
Erythema-Mild (1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Safety as Assessed by Skin Irritation Scores
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 Scores
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 Scores
Rash-No Reaction (0)
|
101 Participants
|
93 Participants
|
96 Participants
|
32 Participants
|
97 Participants
|
99 Participants
|
97 Participants
|
31 Participants
|
|
Safety as Assessed by Skin Irritation Scores
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 Scores
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 Scores
Rash-Severe (3)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety as Assessed by Skin Irritation Scores
Dryness-No Reaction (0)
|
101 Participants
|
93 Participants
|
96 Participants
|
32 Participants
|
97 Participants
|
99 Participants
|
97 Participants
|
31 Participants
|
|
Safety as Assessed by Skin Irritation Scores
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 Scores
Dryness-Moderate (2)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
3M CHG/IPA Prep Tint Abdominal Region
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
3M CHG/IPA Prep Colorless Abdominal Region
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normal Saline Abdominal Region
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
3M CHG/IPA Prep Colorless Inguinal Region
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
3M CHG/IPA Prep Tint Inguinal Region
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normal Saline Inguinal Region
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place