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| Name | Class |
|---|---|
| 3M | INDUSTRY |
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Evaluate persistent antimicrobial effectiveness of chlorhexidine gluconate containing products on abdominal and inguinal sites following a saline and wipe challenge.
Persistent antimicrobial effectiveness was evaluated by measuring the regrowth of normal skin flora at 48 hours, 72 hours and 96 hours, and the suppression of regrowth relative to post-prep (10-min) at 48 hours, 72 hours and 96 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3M CHG/IPA Prep | Experimental | Apply topically for 30 seconds (abdominal site) or 2 minutes (inguinal site), and allow to dry for 3 minutes. |
|
| ChloraPrep | Active Comparator | Apply topically for 30 seconds (abdominal site) or 2 minutes (inguinal site), and allow to dry for 3 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3M CHG/IPA Prep | Drug | Apply topically to intact dry skin (abdominal site) for 30 seconds or moist skin (inguinal site) for 2 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of Skin Flora Recovery Post-prep Application | The primary measure of persistence is the suppression of regrowth recovery relative to baseline (log10 CFU/cm^2) of skin flora at 3 defined post-treatment sampling times. | Baseline, 48-hours post-treatment, 72-hours post-treatment and 96-hours post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Skin Flora Relative to 10 Minutes Post-prep Application | Log10 CFU/cm^2 regrowth of skin flora, relative to 10-minute post-treatment log10 CFU/cm^2, at 3 defined post-treatment sampling times. | 10-minute post-treatment, 48-hours post-treatment, 72-hours post-treatment and 96-hours post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | 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. | Assessed at baseline (pre-treatment) and 10 minutes post-treatment, 48 hours post-treatment, 72 hours post-treatment, 96 hours post-treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rozalia Olsavszky, MD | Evic / Eurofins | Principal Investigator |
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This is a randomized, paired-comparisons design where each subject will receive two of the planned treatments, one on the left side of body and one on the right.
Each subject provides 2 abdomen test sites, left or right, and 2 inguen test sites, left or right. Therefore 69 subjects provide 276 potential test sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | 3M CHG/IPA Prep/Abdominal Region | Experimental CHG/IPA prep was randomly assigned to the left or right side of the abdominal test site |
| FG001 | ChloraPrep/Abdominal Region | Active comparator CHG/IPA prep was randomly assigned to the left or right side of the abdominal test sites |
| FG002 | 3M CHG/IPA Prep/Inguinal Region | Experimental CHG/IPA prep was randomly assigned to the left or right side of the inguinal test site |
| FG003 | ChloraPrep/Inguinal Region | Active comparator prep was randomly assigned to the left or right side of the inguinal test site |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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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.
69 subjects provided 276 baseline test sites (69 rt abd, 69 lt abd, 69 rt ing, 69 lt ing).
| ID | Title | Description |
|---|---|---|
| BG000 | 3M CHG/IPA/Abdominal Region | Investigational CHG/IPA Prep randomly assigned to the left or right abdominal region test sites |
| BG001 | ChloraPrep/Abdominal Region | Active marketed comparator CHG/IPA Prep randomly assigned to the left or right abdominal region test sites |
| 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 | Measurement of Skin Flora Recovery Post-prep Application | The primary measure of persistence is the suppression of regrowth recovery relative to baseline (log10 CFU/cm^2) of skin flora at 3 defined post-treatment sampling times. | 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 CFU/cm^2 on the abdomen test site or > or equal to 5.0 log10 CFU/cm^2 on the inguinal test site. | Posted | Mean | Standard Deviation | log10 CFU/cm^2 | Baseline, 48-hours post-treatment, 72-hours post-treatment and 96-hours post-treatment |
|
Adverse events were collected during the treatment phase of the study. Product remained on each subject's skin for approximately 96 hours.
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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 Abdominal Region | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol 70% (IPA) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joan E. Paulson | 3M | 651-736-6583 | jepaulson@mmm.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 4, 2016 | Mar 12, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C010882 | chlorhexidine gluconate |
| D019840 | 2-Propanol |
| D002710 | Chlorhexidine |
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D020005 | Propanols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D001645 | Biguanides |
| D006146 |
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| ChloraPrep | Drug | Apply topically to intact dry skin (abdominal site) for 30 seconds or moist skin (inguinal site) for 2 minutes. |
|
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| BG002 | 3M CHG/IPA/Inguinal Region | Investigational CHG/IPA Prep randomly assigned to the left or right inguiinal region test sites |
| BG003 | ChloraPrep/Inguinal Region | Active marketed comparator CHG/IPA Prep randomly assigned to the left or right abdominal region test sites |
| BG004 | Total | Total of all reporting groups |
| test sites on skin |
|
| Participants |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants | Participants |
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| Subjects meeting treatment day baseline requirement | Treatment day baseline requirement is defined as greater than or equal to 3.00 log10 CFU/cm^2 bilaterally on the abdomen test site and/or greater than or equal to 5.00 log10 CFU/cm^2 bilaterally on the inguinal test site. | Count of Units | test sites on skin | test sites on skin |
|
| OG001 | Active Comparator Prep - Abdominal Site | Following baseline sample collection participants had ChloraPrep applied to their abdominal test site for 30 seconds and dry for 3 minutes. |
| OG002 | Experimental Prep - Inguinal Site | Following baseline sample collection participants had 3M CHG/IPA Prep applied to their inguinal test site for 2 minutes and dry for 3 minutes. |
| OG003 | Active Comparator Prep - Inguinal Site | Following baseline sample collection participants had ChloraPrep applied to their inguinal test site for 2 minutes and dry for 3 minutes. |
|
|
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| Secondary | Change in Skin Flora Relative to 10 Minutes Post-prep Application | Log10 CFU/cm^2 regrowth of skin flora, relative to 10-minute post-treatment log10 CFU/cm^2, at 3 defined post-treatment sampling times. | The secondary 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 CFU/cm^2 on the abdomen test site or 5.0 log10 CFU/cm^2 on the inguinal test | Posted | Mean | Standard Deviation | log10 CFU/cm^2 | 10-minute post-treatment, 48-hours post-treatment, 72-hours post-treatment and 96-hours post-treatment |
|
|
|
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| Other Pre-specified | Safety Outcome Evaluated by Skin Irritation (Dryness, Edema, Erythema, Rash) Assessment | 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. | Subjects meeting required baseline counts: greater or equal to 3.00 log10 CFU/cm^2 on the abdominal region and greater than or or equal to 5.00 log10 CFU/cm^2 on the inguinal region. | Posted | Number | sites | Assessed at baseline (pre-treatment) and 10 minutes post-treatment, 48 hours post-treatment, 72 hours post-treatment, 96 hours post-treatment |
|
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| 0 |
| 69 |
| 0 |
| 69 |
| 0 |
| 69 |
| EG001 | ChloraPrep CHG/IPA Abdominal Region | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% | 0 | 69 | 0 | 69 | 0 | 69 |
| EG002 | 3M CHG/IPA Prep Inguinal Region | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% | 0 | 69 | 0 | 69 | 0 | 69 |
| EG003 | ChloraPrep CHG/IPA Inguinal Region | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% | 0 | 69 | 0 | 69 | 0 | 69 |
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| Guanidines |
| D000578 | Amidines |
| 72 hour timepoint |
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| 96 hour timepoint |
|
| 72-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 3.0 log10 CFU/cm^2 on the abdomen. The null hypothesis is that there is no difference in log10 CFU /cm^2 regrowth from the 10 minute time point between arms at 72-hours post-treatment. | Paired t-test | 0.68 | Mean Difference (Final Values) | 0.08 | Standard Error of the Mean | 0.19 | 2-Sided | 95 | -0.30 | 0.45 | Superiority |
| 96-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 3.0 log10 CFU/cm^2 on the abdomen. The null hypothesis is that there is no difference in log10 CFU /cm^2 regrowth from the 10 minute time point between arms at 96-hours post-treatment. | Paired t-test | 0.97 | Mean Difference (Final Values) | -0.01 | Standard Error of the Mean | 0.23 | 2-Sided | 95 | -0.47 | 0.45 | Superiority |
| 48-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 5.0 log10 CFU/cm^2 on the inguinal. The null hypothesis is that there is no difference in log10 CFU /cm^2 regrowth from the 10 minute time point between arms at 48-hours post-treatment. | Paired t-test | 0.40 | Mean Difference (Final Values) | 0.19 | Standard Error of the Mean | 0.23 | 2-Sided | 95 | -0.27 | 0.65 | Superiority |
| 72-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 5.0 log10 CFU/cm^2 on the inguinal. The null hypothesis is that there is no difference in log10 CFU /cm^2 regrowth from the 10 minute time point between arms at 72-hours post-treatment. | Paired t-test | 0.03 | Using a Hochberg Step-up procedure the critical p value is 0.17 | Mean Difference (Final Values) | 0.54 | Standard Error of the Mean | 0.25 | 2-Sided | 95 | 0.05 | 1.03 | Superiority |
| 96-hours post-treatment time point. The primary analysis dataset used a modified Intent to Treat population. Subjects were excluded who did not meet the treatment day baseline requirements of greater than or equal to 5.0 log10 CFU/cm^2 on the inguinal. The null hypothesis is that there is no difference in log10 CFU /cm^2 regrowth from the 10 minute time point between arms at 96-hours post-treatment. | Paired t-test | 0.07 | Mean Difference (Final Values) | 0.42 | Standard Error of the Mean | 0.23 | 2-Sided | 95 | -0.03 | 0.87 | Superiority |
| Dryness:10-minute post-treatment rating=0 |
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| Dryness:48 hours post-treatment rating=0 |
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| Dryness:72 hours post-treatment rating=0 |
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| Dryness:96 hours post-treatment rating=0 |
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| Edema:Baseline pre-treatment rating=0 |
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| Edema:10 min post-treatment rating=0 |
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| Edema:48 hours post-treatment rating=0 |
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| Edema:72 hours post-treatment rating=0 |
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| Edema:96 hours post-treatment rating=0 |
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| Erythema:Baseline pre-treatment rating=0 |
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| Erythema:10 min post-treatment rating=0 |
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| Erythema:48 hours post-treatment rating=0 |
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| Erythema:72 hours post-treatment rating=0 |
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| Erythema:96 hours post-treatment rating=0 |
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| Rash:Baseline pre-treatment rating=0 |
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| Rash:10 min post-treatment rating=0 |
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| Rash:48 hours post-treatment rating=0 |
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| Rash:72 hours post-treatment rating=0 |
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| Rash:96 hours post-treatment rating=0 |
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