Bacterial Reduction Post-product Application
Conditions
Keywords
surgical skin prep, CHG, IPA
Brief summary
The objective of this study is to demonstrate the antimicrobial efficacy of the 3M CHG/IPA Prep on skin flora of the abdominal and inguinal regions of human subjects.
Detailed description
The primary efficacy is evaluated by demonstration that the product provides a lower bound of the 95% confidence interval of percent responders that is greater than or equal to 70% On the abdominal site, a responder is defined as a subject with a 2-log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours. On the inguinal site, a responder is defined as a subject with a 3-log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours.
Interventions
DRUG3M CHG/IPA Prep C
Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
DRUG3M CHG/IPA Prep CH
Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
DRUGChloraPrep
Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
DRUGNormal Saline
Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
Sponsors
3M
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects of any race * Subjects in good health * Minimum skin flora baseline requirements on abdomen and groin
Exclusion criteria
* Any tattoos, scars, breaks in the skin, or any form of dermatitis, or other skin disorders (including acne) on the applicable test area * Topical antimicrobial exposure within 14 days prior to screening and treatment days * Use of systemic or topical antibiotics, steroid medications, or any other products known to affect the normal microbial flora of the skin within 14 days prior to screening and treatment days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Responder Rate | baseline, 10 minutes post-product application and 6 hours post-product application | 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. |
| Alternative Primary | Baseline and 10 minutes | 10 minute log reduction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin Flora Recovery 6-hours Post-treatment | 6 hours post-treatment | Log10/cm\^2 recovery of skin flora at 6 hours following application of treatment |
| Skin Flora Recovery 10 Minutes Post-treatment | 10 minute post-product application | Log10/cm\^2 recovery of skin flora at 10 minutes following application of study treatments. |
| Skin Flora Baseline for the Abdomen and Inguinal Region. | Baseline | Log10/cm\^2 baseline skin flora for abdominal and inguinal regions |
| Reduction of Skin Flora 6 Hours Post-treatment | 6 hours | Log10/cm\^2 reduction of skin flora, relative to treatment day baseline, 6 hours post-treatment application |
| Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | 10 minutes post-treatment | 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 |
| Safety as Assessed by Skin Irritation Score | 6 hours post-treatment | Skin irritation rating (0-3) scores for dryness, edema, erythema and rash; 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe. |
| Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Baseline | 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. |
| Reduction of Skin Flora 10 Minutes Post-treatment | 10 minutes | Log10/cm\^2 reduction of skin flora, relative to treatment day baseline (log10/cm\^2) at 10 minutes post-treatment application |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 3M CHG/IPA Prep C - Abdominal Applied topically for 30 seconds to the abdominal test site | 343 |
| 3M CHG/IPA Prep C - Abdominal Applied topically for 30 seconds to the abdominal test site | 343 |
| 3M CHG/IPA Prep CH - Abdominal Applied topically for 30 seconds to the abdominal test site | 344 |
| 3M CHG/IPA Prep CH - Abdominal Applied topically for 30 seconds to the abdominal test site | 344 |
| ChloraPrep - Abdominal Applied topically for 30 seconds to the abdominal test site | 347 |
| ChloraPrep - Abdominal Applied topically for 30 seconds to the abdominal test site | 347 |
| Saline - Abdominal Applied topically for 30 seconds to the abdominal test site | 104 |
| Saline - Abdominal Applied topically for 30 seconds to the abdominal test site | 104 |
| 3M CHG/IPA Prep C - Inguinal Applied topically for 2 minutes to the inguinal test site | 242 |
| 3M CHG/IPA Prep C - Inguinal Applied topically for 2 minutes to the inguinal test site | 242 |
| 3M CHG/IPA Prep CH - Inguinal Applied topically for 2 minutes to the inguinal test site | 244 |
| 3M CHG/IPA Prep CH - Inguinal Applied topically for 2 minutes to the inguinal test site | 244 |
| ChloraPrep - Inguinal Applied topically for 2 minutes to the inguinal test site | 248 |
| ChloraPrep - Inguinal Applied topically for 2 minutes to the inguinal test site | 248 |
| Saline - Inguinal Applied topically for 2 minutes to the inguinal test site | 74 |
| Saline - Inguinal Applied topically for 2 minutes to the inguinal test site | 74 |
| Total | 3,892 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| 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
| Characteristic | Total | 3M CHG/IPA Prep CH - Abdominal | ChloraPrep - Abdominal | Saline - Abdominal | 3M CHG/IPA Prep C - Abdominal | 3M CHG/IPA Prep C - Inguinal | 3M CHG/IPA Prep CH - Inguinal | ChloraPrep - Inguinal | Saline - Inguinal |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 51 Participants | 6 Participants | 15 Participants | 2 Participants | 10 Participants | 6 Participants | 8 Participants | 3 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 1895 Participants | 338 Participants | 332 Participants | 102 Participants | 333 Participants | 236 Participants | 236 Participants | 245 Participants | 73 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 28 Participants | 6 Participants | 3 Participants | 2 Participants | 5 Participants | 3 Participants | 4 Participants | 5 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 48 Participants | 8 Participants | 9 Participants | 1 Participants | 8 Participants | 5 Participants | 8 Participants | 7 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 18 Participants | 2 Participants | 7 Participants | 1 Participants | 6 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Hispanic / Latino | 76 Participants | 9 Participants | 15 Participants | 5 Participants | 13 Participants | 9 Participants | 11 Participants | 14 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiin or Other Pacific Islander | 10 Participants | 2 Participants | 1 Participants | 0 Participants | 3 Participants | 2 Participants | 0 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 28 Participants | 3 Participants | 3 Participants | 1 Participants | 7 Participants | 2 Participants | 4 Participants | 6 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 1776 Participants | 320 Participants | 316 Participants | 96 Participants | 308 Participants | 222 Participants | 222 Participants | 221 Participants | 71 Participants |
| Region of Enrollment United States | 973 participants | 344 participants | 347 participants | 104 participants | 343 participants | 242 participants | 244 participants | 248 participants | 74 participants |
| Sex: Female, Male Female | 538 Participants | 99 Participants | 105 Participants | 32 Participants | 92 Participants | 56 Participants | 64 Participants | 67 Participants | 23 Participants |
| Sex: Female, Male Male | 1408 Participants | 245 Participants | 242 Participants | 72 Participants | 251 Participants | 186 Participants | 180 Participants | 181 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 343 | 0 / 344 | 0 / 347 | 0 / 104 | 0 / 242 | 0 / 244 | 0 / 248 | 0 / 74 |
| other Total, other adverse events | 2 / 343 | 3 / 344 | 1 / 347 | 0 / 104 | 2 / 242 | 3 / 244 | 0 / 248 | 0 / 74 |
| serious Total, serious adverse events | 0 / 343 | 0 / 344 | 0 / 347 | 0 / 104 | 0 / 242 | 0 / 244 | 0 / 248 | 0 / 74 |
Outcome results
Primary
Alternative Primary
10 minute log reduction
Time frame: Baseline and 10 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 3M CHG/IPA Prep C - Abdominal | Alternative Primary | 2.84 log10/cm^2 | Standard Deviation 1.19 |
| 3M CHG/IPA Prep CH - Abdominal | Alternative Primary | 2.99 log10/cm^2 | Standard Deviation 1.12 |
| ChloraPrep - Abdominal | Alternative Primary | 3.17 log10/cm^2 | Standard Deviation 1.24 |
95% CI: [-0.57, -0.1]
Comparison: Since there are two investigational products a Hochberg step-up procedure was used to adjust for multiplicity.97.5% CI: [-0.44, 0.74]
Primary
Responder Rate
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.
Time frame: baseline, 10 minutes post-product application and 6 hours post-product application
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 3M CHG/IPA Prep C - Abdominal | Responder Rate | 159 Participants |
| 3M CHG/IPA Prep CH - Abdominal | Responder Rate | 165 Participants |
| ChloraPrep - Abdominal | Responder Rate | 163 Participants |
| Normal Saline - Abdominal | Responder Rate | 5 Participants |
| 3M CHG/IPA Prep C - Inguinal | Responder Rate | 81 Participants |
| 3M CHG/IPA Prep CH - Inguinal | Responder Rate | 98 Participants |
| ChloraPrep - Inguinal | Responder Rate | 116 Participants |
| Normal Saline - Inguinal | Responder Rate | 1 Participants |
p-value: <0.0001Chi-squared
p-value: <0.0001Chi-squared
p-value: <0.0001Chi-squared
p-value: <0.0001Chi-squared
p-value: <0.0001Chi-squared
p-value: <0.0001Chi-squared
95% CI: [75.6, 86.6]
95% CI: [76.3, 87.1]
95% CI: [77.9, 88.4]
95% CI: [32.3, 45.6]
95% CI: [40.1, 53.7]
95% CI: [46.3, 59.6]
Secondary
Reduction of Skin Flora 10 Minutes Post-treatment
Log10/cm\^2 reduction of skin flora, relative to treatment day baseline (log10/cm\^2) at 10 minutes post-treatment application
Time frame: 10 minutes
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 3M CHG/IPA Prep C - Abdominal | Reduction of Skin Flora 10 Minutes Post-treatment | 2.78 log10/cm^2 skin flora | Standard Deviation 0.935 |
| 3M CHG/IPA Prep CH - Abdominal | Reduction of Skin Flora 10 Minutes Post-treatment | 2.73 log10/cm^2 skin flora | Standard Deviation 1.002 |
| ChloraPrep - Abdominal | Reduction of Skin Flora 10 Minutes Post-treatment | 2.75 log10/cm^2 skin flora | Standard Deviation 0.973 |
| Normal Saline - Abdominal | Reduction of Skin Flora 10 Minutes Post-treatment | 0.76 log10/cm^2 skin flora | Standard Deviation 0.814 |
| 3M CHG/IPA Prep C - Inguinal | Reduction of Skin Flora 10 Minutes Post-treatment | 2.84 log10/cm^2 skin flora | Standard Deviation 1.191 |
| 3M CHG/IPA Prep CH - Inguinal | Reduction of Skin Flora 10 Minutes Post-treatment | 2.99 log10/cm^2 skin flora | Standard Deviation 1.125 |
| ChloraPrep - Inguinal | Reduction of Skin Flora 10 Minutes Post-treatment | 3.17 log10/cm^2 skin flora | Standard Deviation 1.243 |
| Normal Saline - Inguinal | Reduction of Skin Flora 10 Minutes Post-treatment | 1.01 log10/cm^2 skin flora | Standard Deviation 0.668 |
Secondary
Reduction of Skin Flora 6 Hours Post-treatment
Log10/cm\^2 reduction of skin flora, relative to treatment day baseline, 6 hours post-treatment application
Time frame: 6 hours
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 3M CHG/IPA Prep C - Abdominal | Reduction of Skin Flora 6 Hours Post-treatment | 2.83 log10/cm^2 skin flora | Standard Deviation 0.851 |
| 3M CHG/IPA Prep CH - Abdominal | Reduction of Skin Flora 6 Hours Post-treatment | 2.86 log10/cm^2 skin flora | Standard Deviation 0.899 |
| ChloraPrep - Abdominal | Reduction of Skin Flora 6 Hours Post-treatment | 2.83 log10/cm^2 skin flora | Standard Deviation 0.971 |
| Normal Saline - Abdominal | Reduction of Skin Flora 6 Hours Post-treatment | 1.00 log10/cm^2 skin flora | Standard Deviation 0.971 |
| 3M CHG/IPA Prep C - Inguinal | Reduction of Skin Flora 6 Hours Post-treatment | 3.46 log10/cm^2 skin flora | Standard Deviation 1.312 |
| 3M CHG/IPA Prep CH - Inguinal | Reduction of Skin Flora 6 Hours Post-treatment | 3.49 log10/cm^2 skin flora | Standard Deviation 1.329 |
| ChloraPrep - Inguinal | Reduction of Skin Flora 6 Hours Post-treatment | 3.69 log10/cm^2 skin flora | Standard Deviation 1.286 |
| Normal Saline - Inguinal | Reduction of Skin Flora 6 Hours Post-treatment | 1.23 log10/cm^2 skin flora | Standard Deviation 0.732 |
Secondary
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
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.
Time frame: Baseline
Population: The primary safety analysis data set used an Intent-To-Treat (ITT) population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 3M CHG/IPA Prep C - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-No Reaction (0) | 343 participants |
| 3M CHG/IPA Prep C - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-Mild (1) | 0 participants |
| 3M CHG/IPA Prep C - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-Moderate (2) | 0 participants |
| 3M CHG/IPA Prep C - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-Severe (3) | 0 participants |
| 3M CHG/IPA Prep C - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-No Reaction (0) | 343 participants |
| 3M CHG/IPA Prep C - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-Mild (1) | 0 participants |
| 3M CHG/IPA Prep C - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-Moderate (2) | 0 participants |
| 3M CHG/IPA Prep C - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-Severe (3) | 0 participants |
| 3M CHG/IPA Prep C - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-No Reaction (0) | 340 participants |
| 3M CHG/IPA Prep C - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-Mild (1) | 3 participants |
| 3M CHG/IPA Prep C - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-Moderate (2) | 0 participants |
| 3M CHG/IPA Prep C - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-Severe (3) | 0 participants |
| 3M CHG/IPA Prep C - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-No Reaction (0) | 343 participants |
| 3M CHG/IPA Prep C - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-Mild (1) | 0 participants |
| 3M CHG/IPA Prep C - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-Moderate (2) | 0 participants |
| 3M CHG/IPA Prep C - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-Severe (3) | 0 participants |
| 3M CHG/IPA Prep CH - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-No Reaction (0) | 343 participants |
| 3M CHG/IPA Prep CH - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-No Reaction (0) | 344 participants |
| 3M CHG/IPA Prep CH - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-Severe (3) | 0 participants |
| 3M CHG/IPA Prep CH - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-Moderate (2) | 0 participants |
| 3M CHG/IPA Prep CH - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-No Reaction (0) | 344 participants |
| 3M CHG/IPA Prep CH - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-Moderate (2) | 0 participants |
| 3M CHG/IPA Prep CH - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-Severe (3) | 0 participants |
| 3M CHG/IPA Prep CH - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-No Reaction (0) | 344 participants |
| 3M CHG/IPA Prep CH - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-Moderate (2) | 0 participants |
| 3M CHG/IPA Prep CH - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-Mild (1) | 0 participants |
| 3M CHG/IPA Prep CH - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-Severe (3) | 0 participants |
| 3M CHG/IPA Prep CH - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-Mild (1) | 0 participants |
| 3M CHG/IPA Prep CH - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-Mild (1) | 0 participants |
| 3M CHG/IPA Prep CH - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-Moderate (2) | 0 participants |
| 3M CHG/IPA Prep CH - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-Mild (1) | 1 participants |
| 3M CHG/IPA Prep CH - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-Severe (3) | 0 participants |
| ChloraPrep - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-No Reaction (0) | 347 participants |
| ChloraPrep - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-Moderate (2) | 0 participants |
| ChloraPrep - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-Severe (3) | 0 participants |
| ChloraPrep - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-No Reaction (0) | 347 participants |
| ChloraPrep - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-Moderate (2) | 0 participants |
| ChloraPrep - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-Severe (3) | 0 participants |
| ChloraPrep - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-Mild (1) | 0 participants |
| ChloraPrep - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-Moderate (2) | 0 participants |
| ChloraPrep - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-No Reaction (0) | 347 participants |
| ChloraPrep - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-No Reaction (0) | 347 participants |
| ChloraPrep - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-Mild (1) | 0 participants |
| ChloraPrep - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-Severe (3) | 0 participants |
| ChloraPrep - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-Moderate (2) | 0 participants |
| ChloraPrep - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-Mild (1) | 0 participants |
| ChloraPrep - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-Severe (3) | 0 participants |
| ChloraPrep - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-Mild (1) | 0 participants |
| Normal Saline - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-No Reaction (0) | 104 participants |
| Normal Saline - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-Moderate (2) | 0 participants |
| Normal Saline - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-Moderate (2) | 0 participants |
| Normal Saline - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-Severe (3) | 0 participants |
| Normal Saline - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-No Reaction (0) | 104 participants |
| Normal Saline - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-Mild (1) | 0 participants |
| Normal Saline - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-Moderate (2) | 0 participants |
| Normal Saline - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-Severe (3) | 0 participants |
| Normal Saline - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-No Reaction (0) | 104 participants |
| Normal Saline - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-Mild (1) | 0 participants |
| Normal Saline - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-Moderate (2) | 0 participants |
| Normal Saline - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-Severe (3) | 0 participants |
| Normal Saline - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-Severe (3) | 0 participants |
| Normal Saline - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-Mild (1) | 0 participants |
| Normal Saline - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-No Reaction (0) | 104 participants |
| Normal Saline - Abdominal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-Mild (1) | 0 participants |
| 3M CHG/IPA Prep C - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-Severe (3) | 0 participants |
| 3M CHG/IPA Prep C - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-No Reaction (0) | 240 participants |
| 3M CHG/IPA Prep C - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-Moderate (2) | 0 participants |
| 3M CHG/IPA Prep C - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-No Reaction (0) | 240 participants |
| 3M CHG/IPA Prep C - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-No Reaction (0) | 240 participants |
| 3M CHG/IPA Prep C - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-Severe (3) | 0 participants |
| 3M CHG/IPA Prep C - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-Mild (1) | 0 participants |
| 3M CHG/IPA Prep C - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-Mild (1) | 0 participants |
| 3M CHG/IPA Prep C - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-No Reaction (0) | 239 participants |
| 3M CHG/IPA Prep C - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-Moderate (2) | 0 participants |
| 3M CHG/IPA Prep C - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-Moderate (2) | 0 participants |
| 3M CHG/IPA Prep C - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-Mild (1) | 1 participants |
| 3M CHG/IPA Prep C - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-Moderate (2) | 0 participants |
| 3M CHG/IPA Prep C - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-Severe (3) | 0 participants |
| 3M CHG/IPA Prep C - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-Mild (1) | 0 participants |
| 3M CHG/IPA Prep C - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-Severe (3) | 0 participants |
| 3M CHG/IPA Prep CH - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-No Reaction (0) | 244 participants |
| 3M CHG/IPA Prep CH - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-Moderate (2) | 0 participants |
| 3M CHG/IPA Prep CH - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-Mild (1) | 1 participants |
| 3M CHG/IPA Prep CH - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-No Reaction (0) | 243 participants |
| 3M CHG/IPA Prep CH - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-Severe (3) | 0 participants |
| 3M CHG/IPA Prep CH - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-No Reaction (0) | 244 participants |
| 3M CHG/IPA Prep CH - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-Moderate (2) | 0 participants |
| 3M CHG/IPA Prep CH - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-Severe (3) | 0 participants |
| 3M CHG/IPA Prep CH - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-Severe (3) | 0 participants |
| 3M CHG/IPA Prep CH - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-No Reaction (0) | 244 participants |
| 3M CHG/IPA Prep CH - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-Severe (3) | 0 participants |
| 3M CHG/IPA Prep CH - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-Mild (1) | 0 participants |
| 3M CHG/IPA Prep CH - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-Moderate (2) | 0 participants |
| 3M CHG/IPA Prep CH - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-Mild (1) | 0 participants |
| 3M CHG/IPA Prep CH - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-Moderate (2) | 0 participants |
| 3M CHG/IPA Prep CH - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-Mild (1) | 0 participants |
| ChloraPrep - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-Severe (3) | 0 participants |
| ChloraPrep - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-Mild (1) | 0 participants |
| ChloraPrep - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-No Reaction (0) | 248 participants |
| ChloraPrep - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-Moderate (2) | 0 participants |
| ChloraPrep - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-Mild (1) | 1 participants |
| ChloraPrep - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-Severe (3) | 0 participants |
| ChloraPrep - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-Moderate (2) | 0 participants |
| ChloraPrep - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-Moderate (2) | 0 participants |
| ChloraPrep - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-No Reaction (0) | 247 participants |
| ChloraPrep - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-No Reaction (0) | 248 participants |
| ChloraPrep - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-Severe (3) | 0 participants |
| ChloraPrep - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-Moderate (2) | 0 participants |
| ChloraPrep - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-No Reaction (0) | 248 participants |
| ChloraPrep - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-Mild (1) | 0 participants |
| ChloraPrep - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-Severe (3) | 0 participants |
| ChloraPrep - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-Mild (1) | 0 participants |
| Normal Saline - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-Severe (3) | 0 participants |
| Normal Saline - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-No Reaction (0) | 74 participants |
| Normal Saline - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-Mild (1) | 0 participants |
| Normal Saline - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-Mild (1) | 0 participants |
| Normal Saline - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-No Reaction (0) | 74 participants |
| Normal Saline - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-Severe (3) | 0 participants |
| Normal Saline - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-Moderate (2) | 0 participants |
| Normal Saline - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-Mild (1) | 0 participants |
| Normal Saline - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-Severe (3) | 0 participants |
| Normal Saline - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-No Reaction (0) | 74 participants |
| Normal Saline - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-Mild (1) | 0 participants |
| Normal Saline - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-Moderate (2) | 0 participants |
| Normal Saline - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-Moderate (2) | 0 participants |
| Normal Saline - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-Moderate (2) | 0 participants |
| Normal Saline - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-No Reaction (0) | 74 participants |
| Normal Saline - Inguinal | Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-Severe (3) | 0 participants |
Secondary
Safety as Assessed by Skin Irritation Score
Skin irritation rating (0-3) scores for dryness, edema, erythema and rash; 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe.
Time frame: 6 hours post-treatment
Population: The primary safety analysis dataset used an Intent-To-Treat (ITT) population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 3M CHG/IPA Prep C - Abdominal | Safety as Assessed by Skin Irritation Score | Erythema-Mild (1) | 32 Participants |
| 3M CHG/IPA Prep C - Abdominal | Safety as Assessed by Skin Irritation Score | Dryness-No Reaction (0) | 334 Participants |
| 3M CHG/IPA Prep C - Abdominal | Safety as Assessed by Skin Irritation Score | Rash-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep C - Abdominal | Safety as Assessed by Skin Irritation Score | Erythema-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep C - Abdominal | Safety as Assessed by Skin Irritation Score | Erythema-No Reaction (0) | 310 Participants |
| 3M CHG/IPA Prep C - Abdominal | Safety as Assessed by Skin Irritation Score | Edema-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep C - Abdominal | Safety as Assessed by Skin Irritation Score | Edema-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep C - Abdominal | Safety as Assessed by Skin Irritation Score | Rash-No Reaction (0) | 339 Participants |
| 3M CHG/IPA Prep C - Abdominal | Safety as Assessed by Skin Irritation Score | Erythema-Moderate (2) | 1 Participants |
| 3M CHG/IPA Prep C - Abdominal | Safety as Assessed by Skin Irritation Score | Edema-Mild (1) | 0 Participants |
| 3M CHG/IPA Prep C - Abdominal | Safety as Assessed by Skin Irritation Score | Edema-No Reaction (0) | 343 Participants |
| 3M CHG/IPA Prep C - Abdominal | Safety as Assessed by Skin Irritation Score | Rash-Mild (1) | 4 Participants |
| 3M CHG/IPA Prep C - Abdominal | Safety as Assessed by Skin Irritation Score | Dryness-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep C - Abdominal | Safety as Assessed by Skin Irritation Score | Dryness-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep C - Abdominal | Safety as Assessed by Skin Irritation Score | Dryness-Mild (1) | 9 Participants |
| 3M CHG/IPA Prep C - Abdominal | Safety as Assessed by Skin Irritation Score | Rash-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep CH - Abdominal | Safety as Assessed by Skin Irritation Score | Erythema-Mild (1) | 33 Participants |
| 3M CHG/IPA Prep CH - Abdominal | Safety as Assessed by Skin Irritation Score | Dryness-No Reaction (0) | 330 Participants |
| 3M CHG/IPA Prep CH - Abdominal | Safety as Assessed by Skin Irritation Score | Edema-Mild (1) | 0 Participants |
| 3M CHG/IPA Prep CH - Abdominal | Safety as Assessed by Skin Irritation Score | Rash-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep CH - Abdominal | Safety as Assessed by Skin Irritation Score | Dryness-Mild (1) | 14 Participants |
| 3M CHG/IPA Prep CH - Abdominal | Safety as Assessed by Skin Irritation Score | Erythema-No Reaction (0) | 310 Participants |
| 3M CHG/IPA Prep CH - Abdominal | Safety as Assessed by Skin Irritation Score | Edema-No Reaction (0) | 344 Participants |
| 3M CHG/IPA Prep CH - Abdominal | Safety as Assessed by Skin Irritation Score | Erythema-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep CH - Abdominal | Safety as Assessed by Skin Irritation Score | Erythema-Moderate (2) | 1 Participants |
| 3M CHG/IPA Prep CH - Abdominal | Safety as Assessed by Skin Irritation Score | Dryness-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep CH - Abdominal | Safety as Assessed by Skin Irritation Score | Edema-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep CH - Abdominal | Safety as Assessed by Skin Irritation Score | Dryness-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep CH - Abdominal | Safety as Assessed by Skin Irritation Score | Edema-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep CH - Abdominal | Safety as Assessed by Skin Irritation Score | Rash-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep CH - Abdominal | Safety as Assessed by Skin Irritation Score | Rash-Mild (1) | 7 Participants |
| 3M CHG/IPA Prep CH - Abdominal | Safety as Assessed by Skin Irritation Score | Rash-No Reaction (0) | 337 Participants |
| ChloraPrep - Abdominal | Safety as Assessed by Skin Irritation Score | Erythema-Moderate (2) | 0 Participants |
| ChloraPrep - Abdominal | Safety as Assessed by Skin Irritation Score | Erythema-Severe (3) | 0 Participants |
| ChloraPrep - Abdominal | Safety as Assessed by Skin Irritation Score | Rash-No Reaction (0) | 342 Participants |
| ChloraPrep - Abdominal | Safety as Assessed by Skin Irritation Score | Rash-Mild (1) | 5 Participants |
| ChloraPrep - Abdominal | Safety as Assessed by Skin Irritation Score | Rash-Moderate (2) | 0 Participants |
| ChloraPrep - Abdominal | Safety as Assessed by Skin Irritation Score | Rash-Severe (3) | 0 Participants |
| ChloraPrep - Abdominal | Safety as Assessed by Skin Irritation Score | Dryness-No Reaction (0) | 336 Participants |
| ChloraPrep - Abdominal | Safety as Assessed by Skin Irritation Score | Dryness-Mild (1) | 10 Participants |
| ChloraPrep - Abdominal | Safety as Assessed by Skin Irritation Score | Dryness-Moderate (2) | 1 Participants |
| ChloraPrep - Abdominal | Safety as Assessed by Skin Irritation Score | Dryness-Severe (3) | 0 Participants |
| ChloraPrep - Abdominal | Safety as Assessed by Skin Irritation Score | Edema-No Reaction (0) | 347 Participants |
| ChloraPrep - Abdominal | Safety as Assessed by Skin Irritation Score | Edema-Mild (1) | 0 Participants |
| ChloraPrep - Abdominal | Safety as Assessed by Skin Irritation Score | Edema-Moderate (2) | 0 Participants |
| ChloraPrep - Abdominal | Safety as Assessed by Skin Irritation Score | Edema-Severe (3) | 0 Participants |
| ChloraPrep - Abdominal | Safety as Assessed by Skin Irritation Score | Erythema-No Reaction (0) | 332 Participants |
| ChloraPrep - Abdominal | Safety as Assessed by Skin Irritation Score | Erythema-Mild (1) | 15 Participants |
| Normal Saline - Abdominal | Safety as Assessed by Skin Irritation Score | Rash-Severe (3) | 0 Participants |
| Normal Saline - Abdominal | Safety as Assessed by Skin Irritation Score | Edema-No Reaction (0) | 104 Participants |
| Normal Saline - Abdominal | Safety as Assessed by Skin Irritation Score | Edema-Moderate (2) | 0 Participants |
| Normal Saline - Abdominal | Safety as Assessed by Skin Irritation Score | Rash-No Reaction (0) | 103 Participants |
| Normal Saline - Abdominal | Safety as Assessed by Skin Irritation Score | Edema-Mild (1) | 0 Participants |
| Normal Saline - Abdominal | Safety as Assessed by Skin Irritation Score | Dryness-Mild (1) | 3 Participants |
| Normal Saline - Abdominal | Safety as Assessed by Skin Irritation Score | Erythema-No Reaction (0) | 98 Participants |
| Normal Saline - Abdominal | Safety as Assessed by Skin Irritation Score | Erythema-Moderate (2) | 0 Participants |
| Normal Saline - Abdominal | Safety as Assessed by Skin Irritation Score | Dryness-No Reaction (0) | 101 Participants |
| Normal Saline - Abdominal | Safety as Assessed by Skin Irritation Score | Erythema-Mild (1) | 6 Participants |
| Normal Saline - Abdominal | Safety as Assessed by Skin Irritation Score | Dryness-Moderate (2) | 0 Participants |
| Normal Saline - Abdominal | Safety as Assessed by Skin Irritation Score | Rash-Moderate (2) | 0 Participants |
| Normal Saline - Abdominal | Safety as Assessed by Skin Irritation Score | Erythema-Severe (3) | 0 Participants |
| Normal Saline - Abdominal | Safety as Assessed by Skin Irritation Score | Rash-Mild (1) | 1 Participants |
| Normal Saline - Abdominal | Safety as Assessed by Skin Irritation Score | Edema-Severe (3) | 0 Participants |
| Normal Saline - Abdominal | Safety as Assessed by Skin Irritation Score | Dryness-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep C - Inguinal | Safety as Assessed by Skin Irritation Score | Rash-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep C - Inguinal | Safety as Assessed by Skin Irritation Score | Dryness-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep C - Inguinal | Safety as Assessed by Skin Irritation Score | Edema-No Reaction (0) | 242 Participants |
| 3M CHG/IPA Prep C - Inguinal | Safety as Assessed by Skin Irritation Score | Erythema-No Reaction (0) | 227 Participants |
| 3M CHG/IPA Prep C - Inguinal | Safety as Assessed by Skin Irritation Score | Dryness-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep C - Inguinal | Safety as Assessed by Skin Irritation Score | Edema-Mild (1) | 0 Participants |
| 3M CHG/IPA Prep C - Inguinal | Safety as Assessed by Skin Irritation Score | Rash-No Reaction (0) | 230 Participants |
| 3M CHG/IPA Prep C - Inguinal | Safety as Assessed by Skin Irritation Score | Rash-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep C - Inguinal | Safety as Assessed by Skin Irritation Score | Erythema-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep C - Inguinal | Safety as Assessed by Skin Irritation Score | Edema-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep C - Inguinal | Safety as Assessed by Skin Irritation Score | Dryness-Mild (1) | 2 Participants |
| 3M CHG/IPA Prep C - Inguinal | Safety as Assessed by Skin Irritation Score | Dryness-No Reaction (0) | 240 Participants |
| 3M CHG/IPA Prep C - Inguinal | Safety as Assessed by Skin Irritation Score | Erythema-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep C - Inguinal | Safety as Assessed by Skin Irritation Score | Edema-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep C - Inguinal | Safety as Assessed by Skin Irritation Score | Erythema-Mild (1) | 15 Participants |
| 3M CHG/IPA Prep C - Inguinal | Safety as Assessed by Skin Irritation Score | Rash-Mild (1) | 12 Participants |
| 3M CHG/IPA Prep CH - Inguinal | Safety as Assessed by Skin Irritation Score | Erythema-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep CH - Inguinal | Safety as Assessed by Skin Irritation Score | Dryness-No Reaction (0) | 240 Participants |
| 3M CHG/IPA Prep CH - Inguinal | Safety as Assessed by Skin Irritation Score | Dryness-Mild (1) | 4 Participants |
| 3M CHG/IPA Prep CH - Inguinal | Safety as Assessed by Skin Irritation Score | Rash-Mild (1) | 13 Participants |
| 3M CHG/IPA Prep CH - Inguinal | Safety as Assessed by Skin Irritation Score | Dryness-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep CH - Inguinal | Safety as Assessed by Skin Irritation Score | Dryness-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep CH - Inguinal | Safety as Assessed by Skin Irritation Score | Rash-No Reaction (0) | 231 Participants |
| 3M CHG/IPA Prep CH - Inguinal | Safety as Assessed by Skin Irritation Score | Erythema-Mild (1) | 24 Participants |
| 3M CHG/IPA Prep CH - Inguinal | Safety as Assessed by Skin Irritation Score | Edema-No Reaction (0) | 244 Participants |
| 3M CHG/IPA Prep CH - Inguinal | Safety as Assessed by Skin Irritation Score | Edema-Mild (1) | 0 Participants |
| 3M CHG/IPA Prep CH - Inguinal | Safety as Assessed by Skin Irritation Score | Edema-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep CH - Inguinal | Safety as Assessed by Skin Irritation Score | Erythema-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep CH - Inguinal | Safety as Assessed by Skin Irritation Score | Edema-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep CH - Inguinal | Safety as Assessed by Skin Irritation Score | Erythema-No Reaction (0) | 220 Participants |
| 3M CHG/IPA Prep CH - Inguinal | Safety as Assessed by Skin Irritation Score | Rash-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep CH - Inguinal | Safety as Assessed by Skin Irritation Score | Rash-Severe (3) | 0 Participants |
| ChloraPrep - Inguinal | Safety as Assessed by Skin Irritation Score | Erythema-Severe (3) | 0 Participants |
| ChloraPrep - Inguinal | Safety as Assessed by Skin Irritation Score | Edema-No Reaction (0) | 248 Participants |
| ChloraPrep - Inguinal | Safety as Assessed by Skin Irritation Score | Rash-No Reaction (0) | 229 Participants |
| ChloraPrep - Inguinal | Safety as Assessed by Skin Irritation Score | Edema-Moderate (2) | 0 Participants |
| ChloraPrep - Inguinal | Safety as Assessed by Skin Irritation Score | Dryness-No Reaction (0) | 241 Participants |
| ChloraPrep - Inguinal | Safety as Assessed by Skin Irritation Score | Dryness-Severe (3) | 0 Participants |
| ChloraPrep - Inguinal | Safety as Assessed by Skin Irritation Score | Rash-Severe (3) | 0 Participants |
| ChloraPrep - Inguinal | Safety as Assessed by Skin Irritation Score | Edema-Severe (3) | 0 Participants |
| ChloraPrep - Inguinal | Safety as Assessed by Skin Irritation Score | Dryness-Moderate (2) | 0 Participants |
| ChloraPrep - Inguinal | Safety as Assessed by Skin Irritation Score | Dryness-Mild (1) | 7 Participants |
| ChloraPrep - Inguinal | Safety as Assessed by Skin Irritation Score | Erythema-No Reaction (0) | 236 Participants |
| ChloraPrep - Inguinal | Safety as Assessed by Skin Irritation Score | Rash-Moderate (2) | 0 Participants |
| ChloraPrep - Inguinal | Safety as Assessed by Skin Irritation Score | Erythema-Moderate (2) | 0 Participants |
| ChloraPrep - Inguinal | Safety as Assessed by Skin Irritation Score | Erythema-Mild (1) | 12 Participants |
| ChloraPrep - Inguinal | Safety as Assessed by Skin Irritation Score | Rash-Mild (1) | 19 Participants |
| ChloraPrep - Inguinal | Safety as Assessed by Skin Irritation Score | Edema-Mild (1) | 0 Participants |
| Normal Saline - Inguinal | Safety as Assessed by Skin Irritation Score | Edema-Mild (1) | 0 Participants |
| Normal Saline - Inguinal | Safety as Assessed by Skin Irritation Score | Edema-Severe (3) | 0 Participants |
| Normal Saline - Inguinal | Safety as Assessed by Skin Irritation Score | Rash-Severe (3) | 0 Participants |
| Normal Saline - Inguinal | Safety as Assessed by Skin Irritation Score | Rash-Mild (1) | 8 Participants |
| Normal Saline - Inguinal | Safety as Assessed by Skin Irritation Score | Edema-No Reaction (0) | 74 Participants |
| Normal Saline - Inguinal | Safety as Assessed by Skin Irritation Score | Edema-Moderate (2) | 0 Participants |
| Normal Saline - Inguinal | Safety as Assessed by Skin Irritation Score | Erythema-No Reaction (0) | 72 Participants |
| Normal Saline - Inguinal | Safety as Assessed by Skin Irritation Score | Dryness-Severe (3) | 0 Participants |
| Normal Saline - Inguinal | Safety as Assessed by Skin Irritation Score | Rash-Moderate (2) | 0 Participants |
| Normal Saline - Inguinal | Safety as Assessed by Skin Irritation Score | Rash-No Reaction (0) | 66 Participants |
| Normal Saline - Inguinal | Safety as Assessed by Skin Irritation Score | Dryness-Moderate (2) | 0 Participants |
| Normal Saline - Inguinal | Safety as Assessed by Skin Irritation Score | Erythema-Severe (3) | 0 Participants |
| Normal Saline - Inguinal | Safety as Assessed by Skin Irritation Score | Dryness-No Reaction (0) | 73 Participants |
| Normal Saline - Inguinal | Safety as Assessed by Skin Irritation Score | Erythema-Mild (1) | 2 Participants |
| Normal Saline - Inguinal | Safety as Assessed by Skin Irritation Score | Erythema-Moderate (2) | 0 Participants |
| Normal Saline - Inguinal | Safety as Assessed by Skin Irritation Score | Dryness-Mild (1) | 1 Participants |
Secondary
Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score
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
Time frame: 10 minutes post-treatment
Population: The primary safety analysis data set used an Intent to Treat population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 3M CHG/IPA Prep C - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-Severe (3) | 0 participants |
| 3M CHG/IPA Prep C - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-No Reaction | 343 participants |
| 3M CHG/IPA Prep C - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-No Reaction (0) | 343 participants |
| 3M CHG/IPA Prep C - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-Moderate (2) | 0 participants |
| 3M CHG/IPA Prep C - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-Mild (1) | 0 participants |
| 3M CHG/IPA Prep C - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-Severe (3) | 0 participants |
| 3M CHG/IPA Prep C - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-Mild(1) | 0 participants |
| 3M CHG/IPA Prep C - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-Moderate (2) | 0 participants |
| 3M CHG/IPA Prep C - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-Moderate (2) | 0 participants |
| 3M CHG/IPA Prep C - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-No Reaction (0) | 343 participants |
| 3M CHG/IPA Prep C - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-Moderate (2) | 0 participants |
| 3M CHG/IPA Prep C - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-Mild (1) | 2 participants |
| 3M CHG/IPA Prep C - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-No Reaction (0) | 341 participants |
| 3M CHG/IPA Prep C - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-Severe (3) | 0 participants |
| 3M CHG/IPA Prep C - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-Mild (1) | 0 participants |
| 3M CHG/IPA Prep C - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-Severe (3) | 0 participants |
| 3M CHG/IPA Prep CH - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-No Reaction (0) | 344 participants |
| 3M CHG/IPA Prep CH - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-Moderate (2) | 0 participants |
| 3M CHG/IPA Prep CH - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-No Reaction | 344 participants |
| 3M CHG/IPA Prep CH - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-Mild(1) | 0 participants |
| 3M CHG/IPA Prep CH - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-Mild (1) | 1 participants |
| 3M CHG/IPA Prep CH - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-Mild (1) | 0 participants |
| 3M CHG/IPA Prep CH - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-No Reaction (0) | 344 participants |
| 3M CHG/IPA Prep CH - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-Moderate (2) | 0 participants |
| 3M CHG/IPA Prep CH - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-Mild (1) | 0 participants |
| 3M CHG/IPA Prep CH - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-Severe (3) | 0 participants |
| 3M CHG/IPA Prep CH - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-No Reaction (0) | 343 participants |
| 3M CHG/IPA Prep CH - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-Severe (3) | 0 participants |
| 3M CHG/IPA Prep CH - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-Severe (3) | 0 participants |
| 3M CHG/IPA Prep CH - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-Moderate (2) | 0 participants |
| 3M CHG/IPA Prep CH - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-Moderate (2) | 0 participants |
| 3M CHG/IPA Prep CH - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-Severe (3) | 0 participants |
| ChloraPrep - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-Moderate (2) | 0 participants |
| ChloraPrep - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-Moderate (2) | 0 participants |
| ChloraPrep - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-No Reaction (0) | 347 participants |
| ChloraPrep - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-Severe (3) | 0 participants |
| ChloraPrep - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-Moderate (2) | 0 participants |
| ChloraPrep - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-Severe (3) | 0 participants |
| ChloraPrep - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-No Reaction | 347 participants |
| ChloraPrep - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-Mild (1) | 0 participants |
| ChloraPrep - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-Moderate (2) | 0 participants |
| ChloraPrep - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-Severe (3) | 0 participants |
| ChloraPrep - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-No Reaction (0) | 345 participants |
| ChloraPrep - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-Mild (1) | 2 participants |
| ChloraPrep - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-Mild (1) | 0 participants |
| ChloraPrep - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-Severe (3) | 0 participants |
| ChloraPrep - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-No Reaction (0) | 347 participants |
| ChloraPrep - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-Mild(1) | 0 participants |
| Normal Saline - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-Severe (3) | 0 participants |
| Normal Saline - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-No Reaction (0) | 104 participants |
| Normal Saline - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-Moderate (2) | 0 participants |
| Normal Saline - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-Severe (3) | 0 participants |
| Normal Saline - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-No Reaction (0) | 104 participants |
| Normal Saline - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-No Reaction (0) | 104 participants |
| Normal Saline - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-Mild(1) | 0 participants |
| Normal Saline - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-Moderate (2) | 0 participants |
| Normal Saline - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-Severe (3) | 0 participants |
| Normal Saline - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-Mild (1) | 0 participants |
| Normal Saline - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-Moderate (2) | 0 participants |
| Normal Saline - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-Moderate (2) | 0 participants |
| Normal Saline - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-Mild (1) | 0 participants |
| Normal Saline - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-Severe (3) | 0 participants |
| Normal Saline - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-No Reaction | 104 participants |
| Normal Saline - Abdominal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-Mild (1) | 0 participants |
| 3M CHG/IPA Prep C - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-Mild (1) | 0 participants |
| 3M CHG/IPA Prep C - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-Moderate (2) | 0 participants |
| 3M CHG/IPA Prep C - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-No Reaction (0) | 242 participants |
| 3M CHG/IPA Prep C - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-Severe (3) | 0 participants |
| 3M CHG/IPA Prep C - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-No Reaction | 242 participants |
| 3M CHG/IPA Prep C - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-Mild (1) | 0 participants |
| 3M CHG/IPA Prep C - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-Moderate (2) | 0 participants |
| 3M CHG/IPA Prep C - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-No Reaction (0) | 240 participants |
| 3M CHG/IPA Prep C - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-Moderate (2) | 0 participants |
| 3M CHG/IPA Prep C - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-Mild (1) | 2 participants |
| 3M CHG/IPA Prep C - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-Mild(1) | 0 participants |
| 3M CHG/IPA Prep C - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-No Reaction (0) | 242 participants |
| 3M CHG/IPA Prep C - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-Severe (3) | 0 participants |
| 3M CHG/IPA Prep C - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-Moderate (2) | 0 participants |
| 3M CHG/IPA Prep C - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-Severe (3) | 0 participants |
| 3M CHG/IPA Prep C - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-Severe (3) | 0 participants |
| 3M CHG/IPA Prep CH - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-Mild(1) | 0 participants |
| 3M CHG/IPA Prep CH - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-No Reaction (0) | 244 participants |
| 3M CHG/IPA Prep CH - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-Severe (3) | 0 participants |
| 3M CHG/IPA Prep CH - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-Moderate (2) | 0 participants |
| 3M CHG/IPA Prep CH - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-Severe (3) | 0 participants |
| 3M CHG/IPA Prep CH - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-Severe (3) | 0 participants |
| 3M CHG/IPA Prep CH - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-Moderate (2) | 0 participants |
| 3M CHG/IPA Prep CH - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-Severe (3) | 0 participants |
| 3M CHG/IPA Prep CH - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-Moderate (2) | 0 participants |
| 3M CHG/IPA Prep CH - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-No Reaction | 244 participants |
| 3M CHG/IPA Prep CH - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-Moderate (2) | 0 participants |
| 3M CHG/IPA Prep CH - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-No Reaction (0) | 242 participants |
| 3M CHG/IPA Prep CH - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-Mild (1) | 0 participants |
| 3M CHG/IPA Prep CH - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-No Reaction (0) | 244 participants |
| 3M CHG/IPA Prep CH - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-Mild (1) | 2 participants |
| 3M CHG/IPA Prep CH - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-Mild (1) | 0 participants |
| ChloraPrep - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-Mild (1) | 1 participants |
| ChloraPrep - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-Moderate (2) | 0 participants |
| ChloraPrep - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-Severe (3) | 0 participants |
| ChloraPrep - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-Severe (3) | 0 participants |
| ChloraPrep - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-Moderate (2) | 0 participants |
| ChloraPrep - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-Mild (1) | 0 participants |
| ChloraPrep - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-No Reaction (0) | 243 participants |
| ChloraPrep - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-Mild (1) | 5 participants |
| ChloraPrep - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-Severe (3) | 0 participants |
| ChloraPrep - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-Moderate (2) | 0 participants |
| ChloraPrep - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-Severe (3) | 0 participants |
| ChloraPrep - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-Moderate (2) | 0 participants |
| ChloraPrep - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-Mild(1) | 0 participants |
| ChloraPrep - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-No Reaction | 247 participants |
| ChloraPrep - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-No Reaction (0) | 248 participants |
| ChloraPrep - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-No Reaction (0) | 248 participants |
| Normal Saline - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-Severe (3) | 0 participants |
| Normal Saline - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-No Reaction (0) | 73 participants |
| Normal Saline - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-Mild (1) | 1 participants |
| Normal Saline - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-Moderate (2) | 0 participants |
| Normal Saline - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Dryness-Severe (3) | 0 participants |
| Normal Saline - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-No Reaction | 74 participants |
| Normal Saline - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-Mild (1) | 0 participants |
| Normal Saline - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-Moderate (2) | 0 participants |
| Normal Saline - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Edema-Severe (3) | 0 participants |
| Normal Saline - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-No Reaction (0) | 73 participants |
| Normal Saline - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-Mild (1) | 1 participants |
| Normal Saline - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-Moderate (2) | 0 participants |
| Normal Saline - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Erythema-Severe (3) | 0 participants |
| Normal Saline - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-No Reaction (0) | 74 participants |
| Normal Saline - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-Mild(1) | 0 participants |
| Normal Saline - Inguinal | Safety Assessed as Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score | Rash-Moderate (2) | 0 participants |
Secondary
Skin Flora Baseline for the Abdomen and Inguinal Region.
Log10/cm\^2 baseline skin flora for abdominal and inguinal regions
Time frame: Baseline
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 3M CHG/IPA Prep C - Abdominal | Skin Flora Baseline for the Abdomen and Inguinal Region. | 3.63 log10/cm^2 skin flora | Standard Deviation 0.46 |
| 3M CHG/IPA Prep CH - Abdominal | Skin Flora Baseline for the Abdomen and Inguinal Region. | 3.61 log10/cm^2 skin flora | Standard Deviation 0.479 |
| ChloraPrep - Abdominal | Skin Flora Baseline for the Abdomen and Inguinal Region. | 3.64 log10/cm^2 skin flora | Standard Deviation 0.487 |
| Normal Saline - Abdominal | Skin Flora Baseline for the Abdomen and Inguinal Region. | 3.64 log10/cm^2 skin flora | Standard Deviation 0.533 |
| 3M CHG/IPA Prep C - Inguinal | Skin Flora Baseline for the Abdomen and Inguinal Region. | 6.23 log10/cm^2 skin flora | Standard Deviation 0.604 |
| 3M CHG/IPA Prep CH - Inguinal | Skin Flora Baseline for the Abdomen and Inguinal Region. | 6.21 log10/cm^2 skin flora | Standard Deviation 0.563 |
| ChloraPrep - Inguinal | Skin Flora Baseline for the Abdomen and Inguinal Region. | 6.27 log10/cm^2 skin flora | Standard Deviation 0.618 |
| Normal Saline - Inguinal | Skin Flora Baseline for the Abdomen and Inguinal Region. | 6.09 log10/cm^2 skin flora | Standard Deviation 0.626 |
Secondary
Skin Flora Recovery 10 Minutes Post-treatment
Log10/cm\^2 recovery of skin flora at 10 minutes following application of study treatments.
Time frame: 10 minute post-product application
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 3M CHG/IPA Prep C - Abdominal | Skin Flora Recovery 10 Minutes Post-treatment | 0.85 log10/cm^2 skin flora | Standard Deviation 0.947 |
| 3M CHG/IPA Prep CH - Abdominal | Skin Flora Recovery 10 Minutes Post-treatment | 0.88 log10/cm^2 skin flora | Standard Deviation 0.984 |
| ChloraPrep - Abdominal | Skin Flora Recovery 10 Minutes Post-treatment | 0.90 log10/cm^2 skin flora | Standard Deviation 0.938 |
| Normal Saline - Abdominal | Skin Flora Recovery 10 Minutes Post-treatment | 2.88 log10/cm^2 skin flora | Standard Deviation 0.703 |
| 3M CHG/IPA Prep C - Inguinal | Skin Flora Recovery 10 Minutes Post-treatment | 3.39 log10/cm^2 skin flora | Standard Deviation 1.096 |
| 3M CHG/IPA Prep CH - Inguinal | Skin Flora Recovery 10 Minutes Post-treatment | 3.21 log10/cm^2 skin flora | Standard Deviation 1.042 |
| ChloraPrep - Inguinal | Skin Flora Recovery 10 Minutes Post-treatment | 3.08 log10/cm^2 skin flora | Standard Deviation 1.137 |
| Normal Saline - Inguinal | Skin Flora Recovery 10 Minutes Post-treatment | 5.08 log10/cm^2 skin flora | Standard Deviation 0.676 |
Secondary
Skin Flora Recovery 6-hours Post-treatment
Log10/cm\^2 recovery of skin flora at 6 hours following application of treatment
Time frame: 6 hours post-treatment
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 3M CHG/IPA Prep C - Abdominal | Skin Flora Recovery 6-hours Post-treatment | 0.80 log10/cm^2 skin flora | Standard Deviation 0.84 |
| 3M CHG/IPA Prep CH - Abdominal | Skin Flora Recovery 6-hours Post-treatment | 0.74 log10/cm^2 skin flora | Standard Deviation 0.789 |
| ChloraPrep - Abdominal | Skin Flora Recovery 6-hours Post-treatment | 0.81 log10/cm^2 skin flora | Standard Deviation 0.935 |
| Normal Saline - Abdominal | Skin Flora Recovery 6-hours Post-treatment | 2.65 log10/cm^2 skin flora | Standard Deviation 0.886 |
| 3M CHG/IPA Prep C - Inguinal | Skin Flora Recovery 6-hours Post-treatment | 2.76 log10/cm^2 skin flora | Standard Deviation 1.202 |
| 3M CHG/IPA Prep CH - Inguinal | Skin Flora Recovery 6-hours Post-treatment | 2.73 log10/cm^2 skin flora | Standard Deviation 1.22 |
| ChloraPrep - Inguinal | Skin Flora Recovery 6-hours Post-treatment | 2.58 log10/cm^2 skin flora | Standard Deviation 1.182 |
| Normal Saline - Inguinal | Skin Flora Recovery 6-hours Post-treatment | 4.85 log10/cm^2 skin flora | Standard Deviation 0.749 |