Skin Flora Bacterial Reduction Post-product Application
Conditions
Keywords
surgical skin prep, CHG, IPA
Brief summary
The purpose of this study is to evaluate 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 sites, a responder is defined as a subject with a 2-log10 per cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours. On the inguinal sites, a responder is defined as a subject with a 3-log10 per 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 Colorless
Apply topically.
DRUG3M CHG/IPA Prep Tint
Apply topically.
DRUGChloraPrep
Apply topically.
DRUGSaline
Apply topically.
Sponsors
3M
Solventum US LLC
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 general 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 areas * 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 minute post-product application and 6 hour post-product application | 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. |
| Skin Flora Baseline for Abdominal and Inguinal Regions | Baseline | Log10/cm2 baseline skin flora for abdominal and inguinal regions |
| Skin Flora Recovery Post-treatment | 10 minutes and 6 hours post-treatment | Log10/cm2 recovery of skin flora at 10 minutes and 6 hours following application of study treatments for abdominal and inguinal regions |
| Reduction of Skin Flora Post-treatment | Baseline, 10 minutes and 6 hours | Log10/cm2 reduction of skin flora, relative to Treatment Day baseline log10/cm2, at 10 minutes and 6 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety as Assessed by Skin Irritation Scores | Baseline | 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. |
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 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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 101 |
| 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. | 101 |
| 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. | 93 |
| 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. | 93 |
| 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. | 96 |
| 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. | 96 |
| Normal Saline Abdominal Region 0.9% normal saline with applicator
Normal Saline: Apply topically. | 32 |
| Normal Saline Abdominal Region 0.9% normal saline with applicator
Normal Saline: Apply topically. | 32 |
| 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. | 97 |
| 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. | 97 |
| 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. | 99 |
| 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. | 99 |
| 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. | 97 |
| 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. | 97 |
| Normal Saline Inguinal Region 0.9% normal saline with applicator
Normal Saline: Apply topically. | 31 |
| Normal Saline Inguinal Region 0.9% normal saline with applicator
Normal Saline: Apply topically. | 31 |
| Total | 1,292 |
Baseline characteristics
| Characteristic | 3M CHG/IPA Prep Colorless Abdominal Region | 3M CHG/IPA Prep Tint Abdominal Region | ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Normal Saline Abdominal Region | 3M CHG/IPA Prep Colorless Inguinal Region | 3M CHG/IPA Prep Tint Inguinal Region | ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Normal Saline Inguinal Region | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized <=18 years | 0 test sites on skin | 0 test sites on skin | 0 test sites on skin | 0 test sites on skin | 0 test sites on skin | 0 test sites on skin | 0 test sites on skin | 0 test sites on skin | 0 test sites on skin |
| Age, Customized >=66 years | 2 test sites on skin | 1 test sites on skin | 2 test sites on skin | 1 test sites on skin | 1 test sites on skin | 3 test sites on skin | 2 test sites on skin | 0 test sites on skin | 12 test sites on skin |
| Age, Customized Between 18 and 65 years | 99 test sites on skin | 92 test sites on skin | 94 test sites on skin | 31 test sites on skin | 96 test sites on skin | 96 test sites on skin | 95 test sites on skin | 31 test sites on skin | 634 test sites on skin |
| Race/Ethnicity, Customized American Indian or Alaska Native | 4 test sites on skin | 1 test sites on skin | 4 test sites on skin | 1 test sites on skin | 4 test sites on skin | 4 test sites on skin | 3 test sites on skin | 1 test sites on skin | 22 test sites on skin |
| Race/Ethnicity, Customized Asian | 2 test sites on skin | 1 test sites on skin | 3 test sites on skin | 0 test sites on skin | 3 test sites on skin | 1 test sites on skin | 1 test sites on skin | 1 test sites on skin | 12 test sites on skin |
| Race/Ethnicity, Customized Black or Africian American | 3 test sites on skin | 0 test sites on skin | 3 test sites on skin | 0 test sites on skin | 1 test sites on skin | 2 test sites on skin | 2 test sites on skin | 1 test sites on skin | 12 test sites on skin |
| Race/Ethnicity, Customized Hispanic/Latino | 2 test sites on skin | 2 test sites on skin | 3 test sites on skin | 1 test sites on skin | 2 test sites on skin | 3 test sites on skin | 3 test sites on skin | 2 test sites on skin | 18 test sites on skin |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 1 test sites on skin | 1 test sites on skin | 1 test sites on skin | 1 test sites on skin | 2 test sites on skin | 1 test sites on skin | 1 test sites on skin | 0 test sites on skin | 8 test sites on skin |
| Race/Ethnicity, Customized Other | 1 test sites on skin | 2 test sites on skin | 2 test sites on skin | 1 test sites on skin | 1 test sites on skin | 0 test sites on skin | 2 test sites on skin | 1 test sites on skin | 10 test sites on skin |
| Race/Ethnicity, Customized White | 88 test sites on skin | 86 test sites on skin | 80 test sites on skin | 28 test sites on skin | 84 test sites on skin | 88 test sites on skin | 85 test sites on skin | 25 test sites on skin | 564 test sites on skin |
| Sex/Gender, Customized Sex : Female | 23 test sites on skin | 28 test sites on skin | 27 test sites on skin | 7 test sites on skin | 31 test sites on skin | 22 test sites on skin | 21 test sites on skin | 11 test sites on skin | 170 test sites on skin |
| Sex/Gender, Customized Sex : Male | 78 test sites on skin | 65 test sites on skin | 69 test sites on skin | 25 test sites on skin | 66 test sites on skin | 77 test sites on skin | 76 test sites on skin | 20 test sites on skin | 476 test sites on skin |
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 / 93 | 0 / 101 | 0 / 96 | 0 / 32 | 0 / 97 | 0 / 99 | 0 / 97 | 0 / 31 |
| other Total, other adverse events | 0 / 93 | 0 / 101 | 0 / 96 | 0 / 32 | 0 / 97 | 0 / 99 | 0 / 97 | 0 / 31 |
| serious Total, serious adverse events | 0 / 93 | 0 / 101 | 0 / 96 | 0 / 32 | 0 / 97 | 0 / 99 | 0 / 97 | 0 / 31 |
Outcome results
Primary
Reduction of Skin Flora Post-treatment
Log10/cm2 reduction of skin flora, relative to Treatment Day baseline log10/cm2, at 10 minutes and 6 hours
Time frame: Baseline, 10 minutes and 6 hours
Population: 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.
Primary
Responder Rate
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.
Time frame: baseline, 10 minute post-product application and 6 hour post-product application
Population: 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.
Primary
Skin Flora Baseline for Abdominal and Inguinal Regions
Log10/cm2 baseline skin flora for abdominal and inguinal regions
Time frame: Baseline
Population: 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.
Primary
Skin Flora Recovery Post-treatment
Log10/cm2 recovery of skin flora at 10 minutes and 6 hours following application of study treatments for abdominal and inguinal regions
Time frame: 10 minutes and 6 hours post-treatment
Population: 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.
Secondary
Safety as Assessed by Skin Irritation Scores
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.
Time frame: Baseline
Population: \# of sites treated (met inclusion/exclusion criteria including screening day baseline counts)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 3M CHG/IPA Prep Colorless Abdominal Region | Safety as Assessed by Skin Irritation Scores | Edema-No reaction (0) | 101 Participants |
| 3M CHG/IPA Prep Colorless Abdominal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Mild (1) | 0 Participants |
| 3M CHG/IPA Prep Colorless Abdominal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep Colorless Abdominal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep Colorless Abdominal Region | Safety as Assessed by Skin Irritation Scores | Dryness-No reaction (0) | 101 Participants |
| 3M CHG/IPA Prep Colorless Abdominal Region | Safety as Assessed by Skin Irritation Scores | Edema-Mild (1) | 0 Participants |
| 3M CHG/IPA Prep Colorless Abdominal Region | Safety as Assessed by Skin Irritation Scores | Edema-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep Colorless Abdominal Region | Safety as Assessed by Skin Irritation Scores | Edema-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep Colorless Abdominal Region | Safety as Assessed by Skin Irritation Scores | Erythema- No reaction (0) | 99 Participants |
| 3M CHG/IPA Prep Colorless Abdominal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Mild (1) | 2 Participants |
| 3M CHG/IPA Prep Colorless Abdominal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep Colorless Abdominal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep Colorless Abdominal Region | Safety as Assessed by Skin Irritation Scores | Rash-No Reaction (0) | 101 Participants |
| 3M CHG/IPA Prep Colorless Abdominal Region | Safety as Assessed by Skin Irritation Scores | Rash-Mild (1) | 0 Participants |
| 3M CHG/IPA Prep Colorless Abdominal Region | Safety as Assessed by Skin Irritation Scores | Rash-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep Colorless Abdominal Region | Safety as Assessed by Skin Irritation Scores | Rash-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Erythema- No reaction (0) | 90 Participants |
| 3M CHG/IPA Prep Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Edema-No reaction (0) | 93 Participants |
| 3M CHG/IPA Prep Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Edema-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Rash-No Reaction (0) | 93 Participants |
| 3M CHG/IPA Prep Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Dryness-No reaction (0) | 93 Participants |
| 3M CHG/IPA Prep Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Edema-Mild (1) | 0 Participants |
| 3M CHG/IPA Prep Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Edema-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Mild (1) | 0 Participants |
| 3M CHG/IPA Prep Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Rash-Mild (1) | 0 Participants |
| 3M CHG/IPA Prep Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Rash-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Mild (1) | 3 Participants |
| 3M CHG/IPA Prep Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Rash-Severe (3) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Rash-No Reaction (0) | 96 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Edema-Moderate (2) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Edema-Severe (3) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Dryness-No reaction (0) | 96 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Moderate (2) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Severe (3) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Rash-Mild (1) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Rash-Moderate (2) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Erythema- No reaction (0) | 96 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Edema-No reaction (0) | 96 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Mild (1) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Severe (3) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Moderate (2) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Edema-Mild (1) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Rash-Severe (3) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Mild (1) | 0 Participants |
| Normal Saline Abdominal Region | Safety as Assessed by Skin Irritation Scores | Rash-No Reaction (0) | 32 Participants |
| Normal Saline Abdominal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Moderate (2) | 0 Participants |
| Normal Saline Abdominal Region | Safety as Assessed by Skin Irritation Scores | Rash-Moderate (2) | 0 Participants |
| Normal Saline Abdominal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Severe (3) | 0 Participants |
| Normal Saline Abdominal Region | Safety as Assessed by Skin Irritation Scores | Edema-No reaction (0) | 32 Participants |
| Normal Saline Abdominal Region | Safety as Assessed by Skin Irritation Scores | Edema-Mild (1) | 0 Participants |
| Normal Saline Abdominal Region | Safety as Assessed by Skin Irritation Scores | Edema-Moderate (2) | 0 Participants |
| Normal Saline Abdominal Region | Safety as Assessed by Skin Irritation Scores | Edema-Severe (3) | 0 Participants |
| Normal Saline Abdominal Region | Safety as Assessed by Skin Irritation Scores | Erythema- No reaction (0) | 31 Participants |
| Normal Saline Abdominal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Mild (1) | 1 Participants |
| Normal Saline Abdominal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Moderate (2) | 0 Participants |
| Normal Saline Abdominal Region | Safety as Assessed by Skin Irritation Scores | Rash-Severe (3) | 0 Participants |
| Normal Saline Abdominal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Severe (3) | 0 Participants |
| Normal Saline Abdominal Region | Safety as Assessed by Skin Irritation Scores | Rash-Mild (1) | 0 Participants |
| Normal Saline Abdominal Region | Safety as Assessed by Skin Irritation Scores | Dryness-No reaction (0) | 32 Participants |
| Normal Saline Abdominal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Mild (1) | 0 Participants |
| 3M CHG/IPA Prep Colorless Inguinal Region | Safety as Assessed by Skin Irritation Scores | Edema-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep Colorless Inguinal Region | Safety as Assessed by Skin Irritation Scores | Edema-No reaction (0) | 97 Participants |
| 3M CHG/IPA Prep Colorless Inguinal Region | Safety as Assessed by Skin Irritation Scores | Rash-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep Colorless Inguinal Region | Safety as Assessed by Skin Irritation Scores | Dryness-No reaction (0) | 97 Participants |
| 3M CHG/IPA Prep Colorless Inguinal Region | Safety as Assessed by Skin Irritation Scores | Rash-No Reaction (0) | 97 Participants |
| 3M CHG/IPA Prep Colorless Inguinal Region | Safety as Assessed by Skin Irritation Scores | Edema-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep Colorless Inguinal Region | Safety as Assessed by Skin Irritation Scores | Rash-Mild (1) | 0 Participants |
| 3M CHG/IPA Prep Colorless Inguinal Region | Safety as Assessed by Skin Irritation Scores | Edema-Mild (1) | 0 Participants |
| 3M CHG/IPA Prep Colorless Inguinal Region | Safety as Assessed by Skin Irritation Scores | Erythema- No reaction (0) | 97 Participants |
| 3M CHG/IPA Prep Colorless Inguinal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep Colorless Inguinal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep Colorless Inguinal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Mild (1) | 0 Participants |
| 3M CHG/IPA Prep Colorless Inguinal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep Colorless Inguinal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Mild (1) | 0 Participants |
| 3M CHG/IPA Prep Colorless Inguinal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep Colorless Inguinal Region | Safety as Assessed by Skin Irritation Scores | Rash-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Erythema- No reaction (0) | 97 Participants |
| 3M CHG/IPA Prep Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Rash-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Mild (1) | 2 Participants |
| 3M CHG/IPA Prep Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Edema-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Edema-No reaction (0) | 98 Participants |
| 3M CHG/IPA Prep Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Rash-No Reaction (0) | 97 Participants |
| 3M CHG/IPA Prep Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Edema-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Rash-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Dryness-No reaction (0) | 97 Participants |
| 3M CHG/IPA Prep Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Mild (1) | 2 Participants |
| 3M CHG/IPA Prep Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Rash-Mild (1) | 2 Participants |
| 3M CHG/IPA Prep Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Edema-Mild (1) | 1 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Severe (3) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Mild (1) | 1 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Dryness-No reaction (0) | 96 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Edema-Moderate (2) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Mild (1) | 1 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Edema-Severe (3) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Moderate (2) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Moderate (2) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Erythema- No reaction (0) | 96 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Edema-No reaction (0) | 96 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Severe (3) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Rash-Moderate (2) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Rash-No Reaction (0) | 96 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Edema-Mild (1) | 1 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Rash-Severe (3) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Rash-Mild (1) | 1 Participants |
| Normal Saline Inguinal Region | Safety as Assessed by Skin Irritation Scores | Edema-Severe (3) | 0 Participants |
| Normal Saline Inguinal Region | Safety as Assessed by Skin Irritation Scores | Erythema- No reaction (0) | 30 Participants |
| Normal Saline Inguinal Region | Safety as Assessed by Skin Irritation Scores | Edema-Mild (1) | 0 Participants |
| Normal Saline Inguinal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Mild (1) | 1 Participants |
| Normal Saline Inguinal Region | Safety as Assessed by Skin Irritation Scores | Edema-No reaction (0) | 31 Participants |
| Normal Saline Inguinal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Moderate (2) | 0 Participants |
| Normal Saline Inguinal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Mild (1) | 1 Participants |
| Normal Saline Inguinal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Severe (3) | 0 Participants |
| Normal Saline Inguinal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Severe (3) | 0 Participants |
| Normal Saline Inguinal Region | Safety as Assessed by Skin Irritation Scores | Rash-No Reaction (0) | 30 Participants |
| Normal Saline Inguinal Region | Safety as Assessed by Skin Irritation Scores | Rash-Mild (1) | 1 Participants |
| Normal Saline Inguinal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Moderate (2) | 0 Participants |
| Normal Saline Inguinal Region | Safety as Assessed by Skin Irritation Scores | Edema-Moderate (2) | 0 Participants |
| Normal Saline Inguinal Region | Safety as Assessed by Skin Irritation Scores | Rash-Moderate (2) | 0 Participants |
| Normal Saline Inguinal Region | Safety as Assessed by Skin Irritation Scores | Dryness-No reaction (0) | 30 Participants |
| Normal Saline Inguinal Region | Safety as Assessed by Skin Irritation Scores | Rash-Severe (3) | 0 Participants |
Secondary
Safety as Assessed by Skin Irritation Scores
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.
Time frame: 10 minutes post-treatment
Population: \# of sites treated (met inclusion/exclusion criteria including screening day baseline counts
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 3M CHG/IPA Prep Colorless Abdominal Region | Safety as Assessed by Skin Irritation Scores | Edema-No Reaction (0) | 101 Participants |
| 3M CHG/IPA Prep Colorless Abdominal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Mild (1) | 0 Participants |
| 3M CHG/IPA Prep Colorless Abdominal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep Colorless Abdominal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep Colorless Abdominal Region | Safety as Assessed by Skin Irritation Scores | Dryness-No Reaction (0) | 101 Participants |
| 3M CHG/IPA Prep Colorless Abdominal Region | Safety as Assessed by Skin Irritation Scores | Edema-Mild (1) | 0 Participants |
| 3M CHG/IPA Prep Colorless Abdominal Region | Safety as Assessed by Skin Irritation Scores | Edema-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep Colorless Abdominal Region | Safety as Assessed by Skin Irritation Scores | Edema-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep Colorless Abdominal Region | Safety as Assessed by Skin Irritation Scores | Erythema-No Reaction (0) | 98 Participants |
| 3M CHG/IPA Prep Colorless Abdominal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Mild (1) | 3 Participants |
| 3M CHG/IPA Prep Colorless Abdominal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep Colorless Abdominal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep Colorless Abdominal Region | Safety as Assessed by Skin Irritation Scores | Rash-No Reaction (0) | 101 Participants |
| 3M CHG/IPA Prep Colorless Abdominal Region | Safety as Assessed by Skin Irritation Scores | Rash-Mild (1) | 0 Participants |
| 3M CHG/IPA Prep Colorless Abdominal Region | Safety as Assessed by Skin Irritation Scores | Rash-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep Colorless Abdominal Region | Safety as Assessed by Skin Irritation Scores | Rash-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Erythema-No Reaction (0) | 91 Participants |
| 3M CHG/IPA Prep Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Edema-No Reaction (0) | 93 Participants |
| 3M CHG/IPA Prep Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Edema-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Rash-No Reaction (0) | 93 Participants |
| 3M CHG/IPA Prep Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Dryness-No Reaction (0) | 93 Participants |
| 3M CHG/IPA Prep Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Edema-Mild (1) | 0 Participants |
| 3M CHG/IPA Prep Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Edema-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Mild (1) | 0 Participants |
| 3M CHG/IPA Prep Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Rash-Mild (1) | 0 Participants |
| 3M CHG/IPA Prep Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Rash-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Mild (1) | 2 Participants |
| 3M CHG/IPA Prep Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Rash-Severe (3) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Rash-No Reaction (0) | 96 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Edema-Moderate (2) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Edema-Severe (3) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Dryness-No Reaction (0) | 96 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Moderate (2) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Severe (3) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Rash-Mild (1) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Rash-Moderate (2) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Erythema-No Reaction (0) | 96 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Edema-No Reaction (0) | 96 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Mild (1) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Severe (3) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Moderate (2) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Edema-Mild (1) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Rash-Severe (3) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Mild (1) | 0 Participants |
| Normal Saline Abdominal Region | Safety as Assessed by Skin Irritation Scores | Rash-No Reaction (0) | 32 Participants |
| Normal Saline Abdominal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Moderate (2) | 0 Participants |
| Normal Saline Abdominal Region | Safety as Assessed by Skin Irritation Scores | Rash-Moderate (2) | 0 Participants |
| Normal Saline Abdominal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Severe (3) | 0 Participants |
| Normal Saline Abdominal Region | Safety as Assessed by Skin Irritation Scores | Edema-No Reaction (0) | 32 Participants |
| Normal Saline Abdominal Region | Safety as Assessed by Skin Irritation Scores | Edema-Mild (1) | 0 Participants |
| Normal Saline Abdominal Region | Safety as Assessed by Skin Irritation Scores | Edema-Moderate (2) | 0 Participants |
| Normal Saline Abdominal Region | Safety as Assessed by Skin Irritation Scores | Edema-Severe (3) | 0 Participants |
| Normal Saline Abdominal Region | Safety as Assessed by Skin Irritation Scores | Erythema-No Reaction (0) | 31 Participants |
| Normal Saline Abdominal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Mild (1) | 1 Participants |
| Normal Saline Abdominal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Moderate (2) | 0 Participants |
| Normal Saline Abdominal Region | Safety as Assessed by Skin Irritation Scores | Rash-Severe (3) | 0 Participants |
| Normal Saline Abdominal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Severe (3) | 0 Participants |
| Normal Saline Abdominal Region | Safety as Assessed by Skin Irritation Scores | Rash-Mild (1) | 0 Participants |
| Normal Saline Abdominal Region | Safety as Assessed by Skin Irritation Scores | Dryness-No Reaction (0) | 32 Participants |
| Normal Saline Abdominal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Mild (1) | 0 Participants |
| 3M CHG/IPA Prep Colorless Inguinal Region | Safety as Assessed by Skin Irritation Scores | Edema-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep Colorless Inguinal Region | Safety as Assessed by Skin Irritation Scores | Edema-No Reaction (0) | 97 Participants |
| 3M CHG/IPA Prep Colorless Inguinal Region | Safety as Assessed by Skin Irritation Scores | Rash-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep Colorless Inguinal Region | Safety as Assessed by Skin Irritation Scores | Dryness-No Reaction (0) | 97 Participants |
| 3M CHG/IPA Prep Colorless Inguinal Region | Safety as Assessed by Skin Irritation Scores | Rash-No Reaction (0) | 96 Participants |
| 3M CHG/IPA Prep Colorless Inguinal Region | Safety as Assessed by Skin Irritation Scores | Edema-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep Colorless Inguinal Region | Safety as Assessed by Skin Irritation Scores | Rash-Mild (1) | 1 Participants |
| 3M CHG/IPA Prep Colorless Inguinal Region | Safety as Assessed by Skin Irritation Scores | Edema-Mild (1) | 0 Participants |
| 3M CHG/IPA Prep Colorless Inguinal Region | Safety as Assessed by Skin Irritation Scores | Erythema-No Reaction (0) | 96 Participants |
| 3M CHG/IPA Prep Colorless Inguinal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep Colorless Inguinal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep Colorless Inguinal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Mild (1) | 1 Participants |
| 3M CHG/IPA Prep Colorless Inguinal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep Colorless Inguinal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Mild (1) | 0 Participants |
| 3M CHG/IPA Prep Colorless Inguinal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep Colorless Inguinal Region | Safety as Assessed by Skin Irritation Scores | Rash-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Erythema-No Reaction (0) | 97 Participants |
| 3M CHG/IPA Prep Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Rash-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Mild (1) | 2 Participants |
| 3M CHG/IPA Prep Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Edema-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Edema-No Reaction (0) | 98 Participants |
| 3M CHG/IPA Prep Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Rash-No Reaction (0) | 97 Participants |
| 3M CHG/IPA Prep Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Edema-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Rash-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Dryness-No Reaction (0) | 97 Participants |
| 3M CHG/IPA Prep Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Mild (1) | 2 Participants |
| 3M CHG/IPA Prep Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Rash-Mild (1) | 2 Participants |
| 3M CHG/IPA Prep Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Edema-Mild (1) | 1 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Severe (3) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Mild (1) | 1 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Dryness-No Reaction (0) | 96 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Edema-Moderate (2) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Mild (1) | 1 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Edema-Severe (3) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Moderate (2) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Moderate (2) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Erythema-No Reaction (0) | 96 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Edema-No Reaction (0) | 96 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Severe (3) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Rash-Moderate (2) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Rash-No Reaction (0) | 96 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Edema-Mild (1) | 1 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Rash-Severe (3) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Rash-Mild (1) | 1 Participants |
| Normal Saline Inguinal Region | Safety as Assessed by Skin Irritation Scores | Edema-Severe (3) | 0 Participants |
| Normal Saline Inguinal Region | Safety as Assessed by Skin Irritation Scores | Erythema-No Reaction (0) | 30 Participants |
| Normal Saline Inguinal Region | Safety as Assessed by Skin Irritation Scores | Edema-Mild (1) | 0 Participants |
| Normal Saline Inguinal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Mild (1) | 1 Participants |
| Normal Saline Inguinal Region | Safety as Assessed by Skin Irritation Scores | Edema-No Reaction (0) | 31 Participants |
| Normal Saline Inguinal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Moderate (2) | 0 Participants |
| Normal Saline Inguinal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Mild (1) | 1 Participants |
| Normal Saline Inguinal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Severe (3) | 0 Participants |
| Normal Saline Inguinal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Severe (3) | 0 Participants |
| Normal Saline Inguinal Region | Safety as Assessed by Skin Irritation Scores | Rash-No Reaction (0) | 30 Participants |
| Normal Saline Inguinal Region | Safety as Assessed by Skin Irritation Scores | Rash-Mild (1) | 1 Participants |
| Normal Saline Inguinal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Moderate (2) | 0 Participants |
| Normal Saline Inguinal Region | Safety as Assessed by Skin Irritation Scores | Edema-Moderate (2) | 0 Participants |
| Normal Saline Inguinal Region | Safety as Assessed by Skin Irritation Scores | Rash-Moderate (2) | 0 Participants |
| Normal Saline Inguinal Region | Safety as Assessed by Skin Irritation Scores | Dryness-No Reaction (0) | 30 Participants |
| Normal Saline Inguinal Region | Safety as Assessed by Skin Irritation Scores | Rash-Severe (3) | 0 Participants |
Secondary
Safety as Assessed by Skin Irritation Scores
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.
Time frame: 6 hours post-treatment
Population: \# sites treated (met inclusion/exclusion criteria including screening day baseline counts)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 3M CHG/IPA Prep Colorless Abdominal Region | Safety as Assessed by Skin Irritation Scores | Edema-No Reaction (0) | 101 Participants |
| 3M CHG/IPA Prep Colorless Abdominal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Mild (1) | 0 Participants |
| 3M CHG/IPA Prep Colorless Abdominal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep Colorless Abdominal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep Colorless Abdominal Region | Safety as Assessed by Skin Irritation Scores | Dryness-No Reaction (0) | 101 Participants |
| 3M CHG/IPA Prep Colorless Abdominal Region | Safety as Assessed by Skin Irritation Scores | Edema-Mild (1) | 0 Participants |
| 3M CHG/IPA Prep Colorless Abdominal Region | Safety as Assessed by Skin Irritation Scores | Edema-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep Colorless Abdominal Region | Safety as Assessed by Skin Irritation Scores | Edema-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep Colorless Abdominal Region | Safety as Assessed by Skin Irritation Scores | Erythema-No Reaction (0) | 101 Participants |
| 3M CHG/IPA Prep Colorless Abdominal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Mild (1) | 0 Participants |
| 3M CHG/IPA Prep Colorless Abdominal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep Colorless Abdominal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep Colorless Abdominal Region | Safety as Assessed by Skin Irritation Scores | Rash-No Reaction (0) | 101 Participants |
| 3M CHG/IPA Prep Colorless Abdominal Region | Safety as Assessed by Skin Irritation Scores | Rash-Mild (1) | 0 Participants |
| 3M CHG/IPA Prep Colorless Abdominal Region | Safety as Assessed by Skin Irritation Scores | Rash-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep Colorless Abdominal Region | Safety as Assessed by Skin Irritation Scores | Rash-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Erythema-No Reaction (0) | 93 Participants |
| 3M CHG/IPA Prep Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Edema-No Reaction (0) | 93 Participants |
| 3M CHG/IPA Prep Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Edema-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Rash-No Reaction (0) | 93 Participants |
| 3M CHG/IPA Prep Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Dryness-No Reaction (0) | 93 Participants |
| 3M CHG/IPA Prep Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Edema-Mild (1) | 0 Participants |
| 3M CHG/IPA Prep Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Edema-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Mild (1) | 0 Participants |
| 3M CHG/IPA Prep Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Rash-Mild (1) | 0 Participants |
| 3M CHG/IPA Prep Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Rash-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Mild (1) | 0 Participants |
| 3M CHG/IPA Prep Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Rash-Severe (3) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Rash-No Reaction (0) | 96 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Edema-Moderate (2) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Edema-Severe (3) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Dryness-No Reaction (0) | 96 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Moderate (2) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Severe (3) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Rash-Mild (1) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Rash-Moderate (2) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Erythema-No Reaction (0) | 96 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Edema-No Reaction (0) | 96 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Mild (1) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Severe (3) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Moderate (2) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Edema-Mild (1) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Rash-Severe (3) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Mild (1) | 0 Participants |
| Normal Saline Abdominal Region | Safety as Assessed by Skin Irritation Scores | Rash-No Reaction (0) | 32 Participants |
| Normal Saline Abdominal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Moderate (2) | 0 Participants |
| Normal Saline Abdominal Region | Safety as Assessed by Skin Irritation Scores | Rash-Moderate (2) | 0 Participants |
| Normal Saline Abdominal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Severe (3) | 0 Participants |
| Normal Saline Abdominal Region | Safety as Assessed by Skin Irritation Scores | Edema-No Reaction (0) | 32 Participants |
| Normal Saline Abdominal Region | Safety as Assessed by Skin Irritation Scores | Edema-Mild (1) | 0 Participants |
| Normal Saline Abdominal Region | Safety as Assessed by Skin Irritation Scores | Edema-Moderate (2) | 0 Participants |
| Normal Saline Abdominal Region | Safety as Assessed by Skin Irritation Scores | Edema-Severe (3) | 0 Participants |
| Normal Saline Abdominal Region | Safety as Assessed by Skin Irritation Scores | Erythema-No Reaction (0) | 32 Participants |
| Normal Saline Abdominal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Mild (1) | 0 Participants |
| Normal Saline Abdominal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Moderate (2) | 0 Participants |
| Normal Saline Abdominal Region | Safety as Assessed by Skin Irritation Scores | Rash-Severe (3) | 0 Participants |
| Normal Saline Abdominal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Severe (3) | 0 Participants |
| Normal Saline Abdominal Region | Safety as Assessed by Skin Irritation Scores | Rash-Mild (1) | 0 Participants |
| Normal Saline Abdominal Region | Safety as Assessed by Skin Irritation Scores | Dryness-No Reaction (0) | 32 Participants |
| Normal Saline Abdominal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Mild (1) | 0 Participants |
| 3M CHG/IPA Prep Colorless Inguinal Region | Safety as Assessed by Skin Irritation Scores | Edema-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep Colorless Inguinal Region | Safety as Assessed by Skin Irritation Scores | Edema-No Reaction (0) | 97 Participants |
| 3M CHG/IPA Prep Colorless Inguinal Region | Safety as Assessed by Skin Irritation Scores | Rash-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep Colorless Inguinal Region | Safety as Assessed by Skin Irritation Scores | Dryness-No Reaction (0) | 97 Participants |
| 3M CHG/IPA Prep Colorless Inguinal Region | Safety as Assessed by Skin Irritation Scores | Rash-No Reaction (0) | 97 Participants |
| 3M CHG/IPA Prep Colorless Inguinal Region | Safety as Assessed by Skin Irritation Scores | Edema-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep Colorless Inguinal Region | Safety as Assessed by Skin Irritation Scores | Rash-Mild (1) | 0 Participants |
| 3M CHG/IPA Prep Colorless Inguinal Region | Safety as Assessed by Skin Irritation Scores | Edema-Mild (1) | 0 Participants |
| 3M CHG/IPA Prep Colorless Inguinal Region | Safety as Assessed by Skin Irritation Scores | Erythema-No Reaction (0) | 97 Participants |
| 3M CHG/IPA Prep Colorless Inguinal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep Colorless Inguinal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep Colorless Inguinal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Mild (1) | 0 Participants |
| 3M CHG/IPA Prep Colorless Inguinal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep Colorless Inguinal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Mild (1) | 0 Participants |
| 3M CHG/IPA Prep Colorless Inguinal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep Colorless Inguinal Region | Safety as Assessed by Skin Irritation Scores | Rash-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Erythema-No Reaction (0) | 96 Participants |
| 3M CHG/IPA Prep Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Rash-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Mild (1) | 3 Participants |
| 3M CHG/IPA Prep Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Edema-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Edema-No Reaction (0) | 99 Participants |
| 3M CHG/IPA Prep Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Rash-No Reaction (0) | 99 Participants |
| 3M CHG/IPA Prep Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Edema-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Rash-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Dryness-No Reaction (0) | 99 Participants |
| 3M CHG/IPA Prep Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Mild (1) | 0 Participants |
| 3M CHG/IPA Prep Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Severe (3) | 0 Participants |
| 3M CHG/IPA Prep Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Rash-Mild (1) | 0 Participants |
| 3M CHG/IPA Prep Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Moderate (2) | 0 Participants |
| 3M CHG/IPA Prep Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Edema-Mild (1) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Severe (3) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Mild (1) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Dryness-No Reaction (0) | 97 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Edema-Moderate (2) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Mild (1) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Edema-Severe (3) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Moderate (2) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Moderate (2) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Erythema-No Reaction (0) | 97 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Edema-No Reaction (0) | 97 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Severe (3) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Rash-Moderate (2) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Rash-No Reaction (0) | 97 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Edema-Mild (1) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Rash-Severe (3) | 0 Participants |
| ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region | Safety as Assessed by Skin Irritation Scores | Rash-Mild (1) | 0 Participants |
| Normal Saline Inguinal Region | Safety as Assessed by Skin Irritation Scores | Edema-Severe (3) | 0 Participants |
| Normal Saline Inguinal Region | Safety as Assessed by Skin Irritation Scores | Erythema-No Reaction (0) | 30 Participants |
| Normal Saline Inguinal Region | Safety as Assessed by Skin Irritation Scores | Edema-Mild (1) | 0 Participants |
| Normal Saline Inguinal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Mild (1) | 1 Participants |
| Normal Saline Inguinal Region | Safety as Assessed by Skin Irritation Scores | Edema-No Reaction (0) | 31 Participants |
| Normal Saline Inguinal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Moderate (2) | 0 Participants |
| Normal Saline Inguinal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Mild (1) | 0 Participants |
| Normal Saline Inguinal Region | Safety as Assessed by Skin Irritation Scores | Erythema-Severe (3) | 0 Participants |
| Normal Saline Inguinal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Severe (3) | 0 Participants |
| Normal Saline Inguinal Region | Safety as Assessed by Skin Irritation Scores | Rash-No Reaction (0) | 31 Participants |
| Normal Saline Inguinal Region | Safety as Assessed by Skin Irritation Scores | Rash-Mild (1) | 0 Participants |
| Normal Saline Inguinal Region | Safety as Assessed by Skin Irritation Scores | Dryness-Moderate (2) | 0 Participants |
| Normal Saline Inguinal Region | Safety as Assessed by Skin Irritation Scores | Edema-Moderate (2) | 0 Participants |
| Normal Saline Inguinal Region | Safety as Assessed by Skin Irritation Scores | Rash-Moderate (2) | 0 Participants |
| Normal Saline Inguinal Region | Safety as Assessed by Skin Irritation Scores | Dryness-No Reaction (0) | 31 Participants |
| Normal Saline Inguinal Region | Safety as Assessed by Skin Irritation Scores | Rash-Severe (3) | 0 Participants |