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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3M CHG/IPA Prep C | Experimental | Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes. |
|
| 3M CHG/IPA Prep CH | Experimental | Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes. |
|
| ChloraPrep | Active Comparator | Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes. |
|
| Normal Saline | Placebo Comparator | Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3M CHG/IPA Prep C | Drug | Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline, 10 minutes post-product application and 6 hours post-product application |
| Alternative Primary | 10 minute log reduction | Baseline and 10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 hours |
| Reduction of Skin Flora 10 Minutes Post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jamie Miller, ADN | Independent Consultant | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioScience Laboratories, Inc. | Bozeman | Montana | 59718 | United States |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 3M CHG/IPA Prep C - Abdominal | Applied topically to the abdominal region for 30 seconds. |
| FG001 | 3M CHG/IPA Prep CH - Abdominal | Applied topically to the abdominal region for 30 seconds. |
| FG002 | ChloraPrep - Abdominal | Applied topically to the abdominal region for 30 seconds. |
| FG003 | Normal Saline - Abdominal | Applied topically to the abdominal region for 30 seconds. |
| FG004 | 3M CHG/IPA Prep C - Inguinal | Applied topically to the inguinal region for 2 minutes. |
| FG005 | 3M CHG/IPA Prep CH - Inguinal | Applied topically to the inguinal region for 2 minutes. |
| FG006 | ChloraPrep - Inguinal | Applied topically to the inguinal region for 2 minutes. |
| FG007 | Normal Saline - Inguinal | Applied topically to the inguinal region for 2 minutes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Subjects with average screening day baseline counts of greater than or equal to 3.00 log10 CFU/cm2 bilaterally on the abdominal region and/or greater than or equal to 5.00 log10 CFU/cm2 bilaterally on the inguinal region were included in the analysis.
| ID | Title | Description |
|---|---|---|
| BG000 | 3M CHG/IPA Prep C - Abdominal | Applied topically for 30 seconds to the abdominal test site |
| BG001 | 3M CHG/IPA Prep CH - Abdominal | Applied topically for 30 seconds to the abdominal test site |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | baseline, 10 minutes post-product application and 6 hours post-product application |
|
Adverse events were collected after treatment; by definition, all AEs were treatment-emergent.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 3M CHG/IPA Prep C - Abdominal | Applied topically to the abdominal region for 30 seconds. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild severity | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joan Paulson | 3M | 651-736-6583 | jepaulson@mmm.com |
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| ID | Term |
|---|---|
| C010882 | chlorhexidine gluconate |
| D019840 | 2-Propanol |
| D000431 | Ethanol |
| D002864 | Chromogranins |
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D020005 | Propanols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D009419 | Nerve Tissue Proteins |
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|
| 3M CHG/IPA Prep CH | Drug | Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes. |
|
|
| ChloraPrep | Drug | Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes. |
|
|
| Normal Saline | Drug | Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes. |
|
|
Log10/cm^2 reduction of skin flora, relative to treatment day baseline (log10/cm^2) at 10 minutes post-treatment application
| 10 minutes |
| Skin Flora Recovery 6-hours Post-treatment | Log10/cm^2 recovery of skin flora at 6 hours following application of treatment | 6 hours post-treatment |
| Skin Flora Recovery 10 Minutes Post-treatment | Log10/cm^2 recovery of skin flora at 10 minutes following application of study treatments. | 10 minute post-product application |
| Skin Flora Baseline for the Abdomen and Inguinal Region. | Log10/cm^2 baseline skin flora for abdominal and inguinal regions | Baseline |
| 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. | Baseline |
| 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 | 10 minutes post-treatment |
| 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. | 6 hours post-treatment |
| Discontinued early due to compromised test sites |
|
| BG002 | ChloraPrep - Abdominal | Applied topically for 30 seconds to the abdominal test site |
| BG003 | Saline - Abdominal | Applied topically for 30 seconds to the abdominal test site |
| BG004 | 3M CHG/IPA Prep C - Inguinal | Applied topically for 2 minutes to the inguinal test site |
| BG005 | 3M CHG/IPA Prep CH - Inguinal | Applied topically for 2 minutes to the inguinal test site |
| BG006 | ChloraPrep - Inguinal | Applied topically for 2 minutes to the inguinal test site |
| BG007 | Saline - Inguinal | Applied topically for 2 minutes to the inguinal test site |
| BG008 | Total | Total of all reporting groups |
| test sites on skin |
|
| Participants |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Number | participants | Participants |
|
| OG002 | ChloraPrep - Abdominal | Applied topically to the abdominal region for 30 seconds. |
| OG003 | Normal Saline - Abdominal | Applied topically to the abdominal region for 30 seconds. |
| OG004 | 3M CHG/IPA Prep C - Inguinal | Applied topically to the inguinal region for 2 minutes. |
| OG005 | 3M CHG/IPA Prep CH - Inguinal | Applied topically to the inguinal region for 2 minutes. |
| OG006 | ChloraPrep - Inguinal | Applied topically to the inguinal region for 2 minutes. |
| OG007 | Normal Saline - Inguinal | Applied topically to the inguinal region for 2 minutes. |
|
|
|
| Primary | Alternative Primary | 10 minute log reduction | Posted | Mean | Standard Deviation | log10/cm^2 | Baseline and 10 minutes |
|
|
|
|
| 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 | 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). | Posted | Mean | Standard Deviation | log10/cm^2 skin flora | 6 hours |
|
|
|
|
| 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 | 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). | Posted | Mean | Standard Deviation | log10/cm^2 skin flora | 10 minutes |
|
|
|
|
| Secondary | Skin Flora Recovery 6-hours Post-treatment | Log10/cm^2 recovery of skin flora at 6 hours following application of treatment | 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). | Posted | Mean | Standard Deviation | log10/cm^2 skin flora | 6 hours post-treatment |
|
|
|
|
| Secondary | Skin Flora Recovery 10 Minutes Post-treatment | Log10/cm^2 recovery of skin flora at 10 minutes following application of study treatments. | 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). | Posted | Mean | Standard Deviation | log10/cm^2 skin flora | 10 minute post-product application |
|
|
|
|
| Secondary | Skin Flora Baseline for the Abdomen and Inguinal Region. | Log10/cm^2 baseline skin flora for abdominal and inguinal regions | 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). | Posted | Mean | Standard Deviation | log10/cm^2 skin flora | Baseline |
|
|
|
|
| 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. | The primary safety analysis data set used an Intent-To-Treat (ITT) population | Posted | Number | participants | Baseline | test sites on skin | test sites on skin |
|
|
|
| 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 | The primary safety analysis data set used an Intent to Treat population | Posted | Number | participants | 10 minutes post-treatment | test sites on skin | test sites on skin |
|
|
|
| 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. | The primary safety analysis dataset used an Intent-To-Treat (ITT) population | Posted | Count of Participants | Participants | 6 hours post-treatment |
|
|
|
| 0 |
| 343 |
| 0 |
| 343 |
| 2 |
| 343 |
| EG001 | 3M CHG/IPA Prep CH - Abdominal | Applied topically to the abdominal region for 30 seconds. | 0 | 344 | 0 | 344 | 3 | 344 |
| EG002 | ChloraPrep - Abdominal | Applied topically to the abdominal region for 30 seconds. | 0 | 347 | 0 | 347 | 1 | 347 |
| EG003 | Normal Saline - Abdominal | Applied topically to the abdominal region for 30 seconds. | 0 | 104 | 0 | 104 | 0 | 104 |
| EG004 | 3M CHG/IPA Prep C - Inguinal | Applied topically to the inguinal region for 2 minutes. | 0 | 242 | 0 | 242 | 2 | 242 |
| EG005 | 3M CHG/IPA Prep CH - Inguinal | Applied topically to the inguinal region for 2 minutes. | 0 | 244 | 0 | 244 | 3 | 244 |
| EG006 | ChloraPrep - Inguinal | Applied topically to the inguinal region for 2 minutes. | 0 | 248 | 0 | 248 | 0 | 248 |
| EG007 | Normal Saline - Inguinal | Applied topically to the inguinal region for 2 minutes. | 0 | 74 | 0 | 74 | 0 | 74 |
| Moderate severity | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Not related to product | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Possibly related to products | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Probably related to product | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Anticipated | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Unexpected | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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| D011506 |
| Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
Since there are two investigational products a Hochberg step-up procedure was used to adjust for multiplicity.
| Mean Difference (Final Values) |
| -0.18 |
| Standard Error of the Mean |
| 0.11 |
| 2-Sided |
| 97.5 |
| -0.44 |
| 0.74 |
3M CHG/IPA CH - Inguinal minus ChloraPrep - Inguinal |
| Non-Inferiority |
A non-inferior margin of 0.5 log10/cm^2 |
| Mean value |
| 2.86 |
| Standard Deviation |
| 0.90 |
| 2-Sided |
| Other |
Calculate mean value |
| Mean value | 2.83 | Standard Deviation | 0.97 | 2-Sided | Other | Calculate mean value |
| Mean value | 1.00 | Standard Deviation | 0.97 | 2-Sided | Other | Calculate mean value |
| Mean value | 3.46 | Standard Deviation | 1.31 | 2-Sided | Other | Calculate mean value |
| Mean value | 3.49 | Standard Deviation | 1.33 | 2-Sided | Other | Calculate mean value |
| Mean value | 3.69 | Standard Deviation | 1.29 | 2-Sided | Other | Calculate mean value |
| Mean value | 1.23 | Standard Deviation | 0.73 | 2-Sided | Other | Calculate mean value |
| Mean value |
| 2.73 |
| Standard Deviation |
| 1.00 |
| 2-Sided |
| Other |
Calculate mean value |
| Mean value | 2.75 | Standard Deviation | 0.97 | 2-Sided | Other | Calculate mean value |
| Mean value | 0.76 | Standard Deviation | 0.81 | 2-Sided | Other | Calculate mean value |
| Mean value | 2.84 | Standard Deviation | 1.19 | 2-Sided | Other | Calculate mean value |
| Mean value | 2.99 | Standard Deviation | 1.12 | 2-Sided | Other | Calculate mean value |
| Mean value | 3.17 | Standard Deviation | 1.24 | 2-Sided | Other | Calculate mean value |
| Mean value | 1.01 | Standard Deviation | 0.67 | 2-Sided | Other | Calculate mean value |
| Mean value |
| 0.74 |
| Standard Deviation |
| 0.79 |
| 2-Sided |
| Other |
Calculate mean value |
| Mean value | 0.81 | Standard Deviation | 0.94 | 2-Sided | Other | Calculate mean value |
| Mean value | 2.65 | Standard Deviation | 0.89 | 2-Sided | Other | Calculate mean value |
| Mean value | 2.76 | Standard Deviation | 1.20 | 2-Sided | Other | Calculate mean value |
| Mean value | 2.73 | Standard Deviation | 1.22 | 2-Sided | Other | Calculate mean value |
| Mean value | 2.58 | Standard Deviation | 1.18 | 2-Sided | Other | Calculate mean value |
| Mean value | 4.85 | Standard Deviation | 0.75 | 2-Sided | Other | Calculate mean value |
| Mean value |
| 0.87 |
| Standard Deviation |
| 0.98 |
| 2-Sided |
| Other |
Calculate mean value |
| Mean value | 0.89 | Standard Deviation | 0.94 | 2-Sided | Other | Calculate mean value |
| Mean value | 2.88 | Standard Deviation | 0.70 | 2-Sided | Other | Calculate mean value |
| Mean value | 3.39 | Standard Deviation | 1.10 | 2-Sided | Other | Calculate mean value |
| Mean value | 3.21 | Standard Deviation | 1.04 | 2-Sided | Other | Calculate mean value |
| Mean value | 3.08 | Standard Deviation | 1.14 | 2-Sided | Other | Calculate mean value |
| Mean value | 5.08 | Standard Deviation | 0.68 | 2-Sided | Other | Calculate mean value |
| Mean value |
| 3.61 |
| Standard Deviation |
| 0.48 |
| 2-Sided |
| Other |
Calculate mean value |
| Mean value | 3.64 | Standard Deviation | 0.49 | 2-Sided | Other | Calculate mean value |
| Mean value | 3.64 | Standard Deviation | 0.53 | 2-Sided | Other | Calculate mean value |
| Mean value | 6.23 | Standard Deviation | 0.60 | 2-Sided | Other | Calculate mean value |
| Mean value | 6.22 | Standard Deviation | 0.56 | 2-Sided | Other | Calculate mean value |
| Mean value | 6.27 | Standard Deviation | 0.62 | 2-Sided | Other | Calculate mean value |
| Mean value | 6.09 | Standard Deviation | 0.63 | 2-Sided | Other | Calculate mean value |
| test sites on skin |
|
| Dryness-Mild (1) |
|
| Dryness-Moderate (2) |
|
| Dryness-Severe (3) |
|
| Edema-No Reaction (0) |
|
| Edema-Mild (1) |
|
| Edema-Moderate (2) |
|
| Edema-Severe (3) |
|
| Erythema-No Reaction (0) |
|
| Erythema-Mild (1) |
|
| Erythema-Moderate (2) |
|
| Erythema-Severe (3) |
|
| Rash-No Reaction (0) |
|
| Rash-Mild (1) |
|
| Rash-Moderate (2) |
|
| Rash-Severe (3) |
|
| test sites on skin |
|
| Dryness-Mild (1) |
|
| Dryness-Moderate (2) |
|
| Dryness-Severe (3) |
|
| Edema-No Reaction |
|
| Edema-Mild (1) |
|
| Edema-Moderate (2) |
|
| Edema-Severe (3) |
|
| Erythema-No Reaction (0) |
|
| Erythema-Mild (1) |
|
| Erythema-Moderate (2) |
|
| Erythema-Severe (3) |
|
| Rash-No Reaction (0) |
|
| Rash-Mild(1) |
|
| Rash-Moderate (2) |
|
| Rash-Severe (3) |
|
| Dryness-Mild (1) |
|
| Dryness-Moderate (2) |
|
| Dryness-Severe (3) |
|
| Edema-No Reaction (0) |
|
| Edema-Mild (1) |
|
| Edema-Moderate (2) |
|
| Edema-Severe (3) |
|
| Erythema-No Reaction (0) |
|
| Erythema-Mild (1) |
|
| Erythema-Moderate (2) |
|
| Erythema-Severe (3) |
|
| Rash-No Reaction (0) |
|
| Rash-Mild (1) |
|
| Rash-Moderate (2) |
|
| Rash-Severe (3) |
|