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| Name | Class |
|---|---|
| 3M | INDUSTRY |
The purpose of this study is to determine 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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ChloraPrep Hi-Lite Orange | 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. |
|
| 3M CHG/IPA Prep Tint 10.5 mL | 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 Tint 26-mL | Experimental | 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 |
|---|---|---|---|---|
| ChloraPrep Hi-Lite Orange | Drug | Apply topically. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. 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. | baseline, 10 minutes post-product application and 6 hour post-product application |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of Skin Flora 6 Hours Post-treatment | log10/cm2 reduction of skin flora, relative to treatment day baseline (log10/cm2), at 6 hours post-treatment | 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 |
|---|---|---|
| Muhammad H Bashir, MD, CCRP | MICROBIOTEST | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Microbiotest | Sterling | Virginia | 20164 | 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 sites, left & right and/or 2 inguen test sites, left & right.
406 subjects were randomized for the abdomen region & 391 subjects randomized for the inguen region resulting in 426 subjects providing 1594 applications of test products on 2 anatomical regions.
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| ID | Title | Description |
|---|---|---|
| FG000 | ChloraPrep Hi-Lite Orange - Abdominal | Applied topically to the abdominal region for 30 seconds. |
| FG001 | Normal Saline - Abdominal | Applied topically to the abdominal region for 30 seconds. |
| FG002 | 3M CHG/IPA Prep Tint 10.5-mL - Abdominal | Applied topically to the abdominal region for 30 seconds. |
| FG003 | 3M CHG/IPA Prep Tint 26-mL - Abdominal | Applied topically to the abdominal region for 30 seconds. |
| FG004 | ChloraPrep Hi-Lite Orange - Inguinal | Applied topically to the inguinal region for 2 minutes. |
| FG005 | Normal Saline - Inguinal | Applied topically to the inguinal region for 2 minutes. |
| FG006 | 3M CHG/IPA Prep Tint 10.5-mL - Inguinal | Applied topically to the inguinal region for 2 minutes. |
| FG007 | 3M CHG/IPA Prep Tint 26-mL - Inguinal | Applied topically to the inguinal region for 2 minutes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Subjects with average treatment 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 | ChloraPrep Hi-Lite Orange - Abdominal | ChloraPrep 2% CHG/70% IPA 26-mL applicator applied topically for 30 seconds. |
| BG001 | Normal Saline - Abdominal | Normal Saline with applicator applied topically for 30 seconds. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 was a subject with a 2 log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora did not return to baseline. On the inguinal region a responder was a subject with a 3 log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora did not return to baseline. | The primary analysis data set used a Modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of either > or equal to 3.0 log10 on the abdomen test site or 5.0 log10 on the inguinal test site. | Posted | Count of Participants | Participants | baseline, 10 minutes post-product application and 6 hour post-product application |
|
Adverse events were collected on treatment day. 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 | ChloraPrep Hi-Lite Orange - Abdominal | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 26-mL applied topically to the abdominal region for 30 seconds. ChloraPrep Hi-Lite Orange: Apply topically. |
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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 |
| D000431 | Ethanol |
| D019840 | 2-Propanol |
| D002864 | Chromogranins |
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D009419 | Nerve Tissue Proteins |
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| Normal saline | Drug | Apply topically. |
|
|
| 3M CHG/IPA Prep Tint 10.5-mL | Drug | Apply topically. |
|
|
| 3M CHG/IPA Prep Tint 26-mL | Drug | Apply topically |
|
|
log10/cm2 reduction of skin flora, relative to treatment day baseline (log10/cm2), at 10 minutes post-treatment
| 10 minutes |
| Skin Flora Recovery 6-hours Post-treatment | Log10/cm2 recovery of skin flora at 6 hours following application of study treatment | 6 hours post-treatment |
| Skin Flora Recovery 10 Minutes Post-treatment | Log10/cm2 recovery of skin flora at 10 minutes following application of study treatments | 10 minutes post-treatment |
| Skin Flora Baseline for the Abdominal and Inguinal Region. | Log10/cm2 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=moderated, 3=severe | Assessed at baseline (pre-treatment) and 10 minute post-treatment and 6 hour post-treatment. |
| BG002 | 3M CHG/IPA Prep Tint 10.5-mL - Abdominal | 3M CHG/IPA 2% CHG/70% IPA 10.5-mL applicator applied topically for 30 seconds. |
| BG003 | 3M CHG/IPA Prep Tint 26-mL - Abdominal | 3M CHG/IPA 2% CHG/70% IPA 26-mL applicator applied topically for 30 seconds. |
| BG004 | ChloraPrep Hi-Lite Orange - Inguinal | ChloraPrep 2% CHG/70% IPA 26-mL applicator applied topically for 2 minutes. |
| BG005 | Normal Saline - Inguinal | Normal Saline with applicator applied topically for 2 minutes. |
| BG006 | 3M CHG/IPA Prep Tint 10.5-mL - Inguinal | 3M CHG/IPA 2% CHG/70% IPA 10.5-mL applicator applied topically for 2 minutes. |
| BG007 | 3M CHG/IPA Prep 26-mL - Inguinal | 3M CHG/IPA 2% CHG/70% IPA 26-mL applicator applied topically for 2 minutes. |
| BG008 | Total | Total of all reporting groups |
| Test sites on skin |
|
| participants |
| Test sites on skin |
|
| Sex/Gender, Customized | Number | participants | Test sites on skin |
|
| Race/Ethnicity, Customized | Number | participants | Test sites on skin |
|
| Region of Enrollment | Number | participants | Test sites on skin |
|
| OG001 | 3M CHG/IPA Prep Tint 10.5-mL - Abdominal | Applied topically to the abdominal region for 30 seconds. |
| OG002 | 3M CHG/IPA Prep Tint 26-mL - Abdominal | Applied topically to the abdominal region for 30 seconds. |
| OG003 | Normal Saline - Abdominal | Apply topically to the abdominal region for 30 seconds |
| OG004 | ChloraPrep Hi-Lite Orange - Inguinal | Applied topically to the inguinal region for 2 minutes. |
| OG005 | 3M CHG/IPA Prep Tint 10.5-mL - Inguinal | Applied topically to the inguinal region for 2 minutes. |
| OG006 | 3M CHG/IPA Prep Tint 26-mL - Inguinal | Applied topically to the inguinal region for 2 minutes |
| OG007 | Normal Saline - Inguinal | Apply topically to the inguinal region for 2 minutes |
|
|
| Secondary | Reduction of Skin Flora 6 Hours Post-treatment | log10/cm2 reduction of skin flora, relative to treatment day baseline (log10/cm2), at 6 hours post-treatment | The primary analysis data set used a Modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of either > or equal to 3.0 log10 on the abdomen test site or 5.0 log10 on the inguinal test site. | Posted | Mean | Standard Deviation | log10/cm2 | 6 hours |
|
|
|
| Secondary | Reduction of Skin Flora 10 Minutes Post-treatment | log10/cm2 reduction of skin flora, relative to treatment day baseline (log10/cm2), at 10 minutes post-treatment | The primary analysis data set used a Modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of either > or equal to 3.0 log10 on the abdomen test site or 5.0 log10 on the inguinal test site. | Posted | Mean | Standard Deviation | log10/cm2 | 10 minutes |
|
|
|
| Secondary | Skin Flora Recovery 6-hours Post-treatment | Log10/cm2 recovery of skin flora at 6 hours following application of study treatment | The primary analysis data set used a Modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of either > or equal to 3.0 log10 on the abdomen test site or 5.0 log10 on the inguinal test site. | Posted | Mean | Standard Deviation | log10/cm2 skin flora | 6 hours post-treatment |
|
|
|
| Secondary | Skin Flora Recovery 10 Minutes Post-treatment | Log10/cm2 recovery of skin flora at 10 minutes following application of study treatments | The primary analysis data set used a Modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of either > or equal to 3.0 log10 on the abdomen test site or 5.0 log10 on the inguinal test site. | Posted | Mean | Standard Deviation | log10/cm2 skin flora | 10 minutes post-treatment |
|
|
|
| Secondary | Skin Flora Baseline for the Abdominal and Inguinal Region. | Log10/cm2 baseline skin flora for abdominal and inguinal regions | The primary analysis data set used a Modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of either > or equal to 3.0 log10 on the abdomen test site or 5.0 log10 on the inguinal test site. | Posted | Mean | Standard Deviation | log10/cm2 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=moderated, 3=severe | The primary safety analysis data set used an Intent to Treat population. | Posted | Number | test sites on skin | Assessed at baseline (pre-treatment) and 10 minute post-treatment and 6 hour post-treatment. |
|
|
|
| 0 |
| 247 |
| 0 |
| 247 |
| 0 |
| 247 |
| EG001 | Normal Saline - Abdominal | 0.9% normal saline applied topically to the abdominal region for 30 seconds. Normal Saline: Apply topically. | 0 | 74 | 0 | 74 | 0 | 74 |
| EG002 | 3M CHG/IPA Prep Tint 10.5-mL - Abdominal | Chlorhexidine gluconate 2% / Isopropyl alcohol 70% 10.5 mL applied topically to the abdominal region for 30 seconds. 3M CHG/IPA Prep Tint 10.5-mL: Apply topically. | 0 | 246 | 0 | 246 | 0 | 246 |
| EG003 | 3M CHG/IPA Prep Tint 26-mL - Abdominal | Chlorhexidine gluconate 2% / Isopropyl alcohol 70% 26 mL applied topically to the abdominal region for 30 seconds. 3M CHG/IPA Prep Tint 26-mL: Apply topically | 0 | 245 | 0 | 245 | 0 | 245 |
| EG004 | ChloraPrep Hi-Lite Orange - Inguinal | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% 26-mL applied topically to the inguinal region for 2 minutes. ChloraPrep Hi-Lite Orange: Apply topically. | 0 | 236 | 0 | 236 | 0 | 236 |
| EG005 | Normal Saline - Inguinal | 0.9% normal saline applied topically to the inguinal region for 2 minutes. Normal Saline: Apply topically. | 0 | 70 | 0 | 70 | 0 | 70 |
| EG006 | 3M CHG/IPA Prep Tint 10.5-mL - Inguinal | Chlorhexidine gluconate 2% / Isopropyl alcohol 70% 10.5 mL applied topically to the inguinal region for 2 minutes. 3M CHG/IPA Prep Tint 10.5-mL: Apply topically. | 0 | 238 | 0 | 238 | 0 | 238 |
| EG007 | 3M CHG/IPA Prep Tint 26-mL - Inguinal | Chlorhexidine gluconate 2% / Isopropyl alcohol 70% 26 mL applied topically to the inguinal region for 2 minutes 3M CHG/IPA Prep Tint 26-mL: Apply topically | 0 | 238 | 0 | 238 | 0 | 238 |
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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 |
| Baseline Dryness-Mild (1) |
|
| Baseline Dryness-Moderate (2) |
|
| Baseline Dryness-Severe (3) |
|
| Baseline Edema-No Reaction (0) |
|
| Baseline Edema-Mild (1) |
|
| Baseline Edema-Moderate (2) |
|
| Baseline Edema-Severe (3) |
|
| Baseline Erythema-No Reaction (0) |
|
| Baseline Erythema-Mild (1) |
|
| Baseline Erythema-Moderate (2) |
|
| Baseline Erythema-Severe (3) |
|
| Baseline Rash-No Reaction (0) |
|
| Baseline Rash-Mild (1) |
|
| Baseline Rash-Moderate (2) |
|
| Baseline Rash-Severe (3) |
|
| 10 minute Dryness-No Reaction (0) |
|
| 10 minute Dryness-Mild (1) |
|
| 10 minute Dryness-Moderate (2) |
|
| 10 minute Dryness-Severe (3) |
|
| 10 minute Edema-No Reaction (0) |
|
| 10 minute Edema-Mild (1) |
|
| 10 minute Edema-Moderate (2) |
|
| 10 minute Edema-Severe (3) |
|
| 10 minute Erythema-No Reaction (0) |
|
| 10 minute Erythema-Mild (1) |
|
| 10 minute Erythema-Moderate (2) |
|
| 10 minute Erythema-Severe (3) |
|
| 10 minute Rash-No Reaction (0) |
|
| 10 minute Rash-Mild (1) |
|
| 10 minute Rash-Mild (2) |
|
| 10 minute Rash-Severe (3) |
|
| 6 hour Dryness-No Reaction (0) |
|
| 6 hour Dryness-Mild (1) |
|
| 6 hour Dryness-Moderate (2) |
|
| 6 hour Dryness-Severe (3) |
|
| 6 hour Edema-No Reaction (0) |
|
| 6 hour Edema-Mild (1) |
|
| 6 hour Edema-Moderate (2) |
|
| 6 hour Edema-Severe (3) |
|
| 6 hour Erythema-No Reaction (0) |
|
| 6 hour Erythema-Mild (1) |
|
| 6 hour Erythema-Moderate (2) |
|
| 6 hour Erythema-Severe (3) |
|
| 6 hour Rash-No Reaction (0) |
|
| 6 hour Rash-Mild (1) |
|
| 6 hour Rash-Moderate (2) |
|
| 6 hour Rash-Severe (3) |
|