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| Name | Class |
|---|---|
| 3M | INDUSTRY |
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The objective of the study is to demonstrate persistence of the CHG/IPA Prep on skin flora of the abdominal and inguinal regions of human subjects.
The objective of the study is to demonstrate persistence of the CHG/IPA Prep versus a saline placebo on skin flora of the abdominal and inguinal regions of human subjects as measured by change in microbial flora relative to baseline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3M CHG/IPA - Abdominal Region | Experimental | Apply Chlorhexidine (CHG) 2% / Isopropyl alcohol (IPA) 70% for 30 seconds and allow to dry for 3 minutes. |
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| Normal Saline - Abdominal Region | Placebo Comparator | Apply 0.9% sodium chloride with applicator for 30 seconds and allow to dry for 3 minutes. |
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| 3M CHG/IPA - Inguinal Region | Experimental | Apply Chlorhexidine (CHG) 2% / Isopropyl alcohol (IPA) 70% for 30 seconds and allow to dry for 3 minutes. |
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| Normal Saline - Inguinal Region | Placebo Comparator | Apply 0.9% sodium chloride with applicator for 30 seconds and allow to dry for 3 minutes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3M CHG/IPA Surgical Skin Preparation - Abdominal Region | Drug | Chlorhexidine gluconate 2% / Isopropyl alcohol 70% |
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| Measure | Description | Time Frame |
|---|---|---|
| Measurement of Skin Flora Recovery Post-prep Application Relative to Baseline | The primary measure of persistence is the suppression of regrowth recovery relative to baseline (log10 CFU/cm^2) of skin flora at two defined post-prep sampling times relative to baseline. | Baseline, 48 hours and 72 hours post-prep application |
| Measure | Description | Time Frame |
|---|---|---|
| Safety as Assessed by Skin Irritation Scores Coded by Study Staff | For the conditions of erythema, edema, rash, and dryness, a rating of 0 (no reaction), 1 (mild and/or transient, limited to sensitive area), 2 (moderate, persisting over much of the product-exposed area), or 3 (severe, extending over most or all of the product-exposed area) was recorded on the Skin Irritation Rating form of the eCRF. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Muhammad H Bashir, MD, CCRP | MicroBioTest Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MicroBioTest | Sterling | Virginia | 20164 | United States |
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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 provided two abdomen test sites, left or right, and/or two inguinal test sites, left or right. A total of 25 subjects were randomized to the abdomen region and 23 subjects were randomized to the inguinal region resulting in 27 subjects providing 96 application test sites on two anatomical regions.
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| ID | Title | Description |
|---|---|---|
| FG000 | 3M CHG/IPA - Abdominal Region | Experimental CHG/IPA Prep was randomly assigned to the left or right side of the abdominal test site |
| FG001 | Normal Saline - Abdominal Region | Saline control was randomly assigned to the left or right side of the abdominal test site |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Normal Saline - Abdominal Region | Other | 0.9% sodium chloride applied with foam applicator |
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| 3M CHG/IPA Surgical Skin Preparation - Inguinal Region | Drug | Chlorhexidine gluconate 2% / Isopropyl alcohol 70% |
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| Normal Saline - Inguinal Region | Other | 0.9% sodium chloride applied with foam applicator |
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| 48 hours and 72 hours post-product application |
| Safety as Assessed by Adverse Events | Number of subjects with adverse events as self-reported or identified by study staff | To 72 hours post treatment |
| 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 | Normal Saline - Inguinal Region | Saline control was randomly assigned to the left or right side of the inguinal test site |
| COMPLETED |
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| NOT COMPLETED |
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Subjects with average treatment day baseline counts of > or equal to 3.00 log10 CFU/cm2 bilaterally on abdominal (abd) region and/or > or equal to 5.00 log10 CFU/cm2 bilaterally on inguinal (ing) region were included in the analysis.
27 unique subjects provided 50 abd baseline test sites (25 rt & 25 lt) & 46 ing test sites (23 right & 23 left).
21 unique subjects provided abd & ing test sites; 4 unique subjects provided abd only test sites; 2 unique subjects provided ing only test sites.
| ID | Title | Description |
|---|---|---|
| BG000 | 3M CHG/IPA - Abdominal Region - Left or Right | Experimental CHG/IPA Prep was randomly assigned to the left or right side of the abdominal test site |
| BG001 | Normal Saline - Abdominal Region - Left or Right | Saline control was randomly assigned to the left or right side of the abdominal test site |
| BG002 | 3M CHG/IPA Prep - Inguinal Region - Left or Right | Experimental CHG/IPA Prep was randomly assigned to the left or right side of the inguinal test site |
| BG003 | Normal Saline - Inguinal Region - Left or Right | Saline control was randomly assigned to the left or right side of the inguinal test site |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Test sites on skin |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left). | Number | Test sites on skin | Test sites on skin |
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| Sex/Gender, Customized | Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left). | Number | Test sites on skin | Test sites on skin |
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| Race/Ethnicity, Customized | Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left). | Number | Test sites on skin | Test sites on skin |
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| Region of Enrollment | Twenty-seven (27) unique subjects provided 50 abdominal baseline test sites (25 right and 25 left) and 46 inguinal test sites (23 right and 23 left). | Number | participants | Participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Measurement of Skin Flora Recovery Post-prep Application Relative to Baseline | The primary measure of persistence is the suppression of regrowth recovery relative to baseline (log10 CFU/cm^2) of skin flora at two defined post-prep sampling times relative to baseline. | Number analyzed includes subjects who met baseline requirements | Posted | Mean | Standard Deviation | Log10 CFU/cm^2 | Baseline, 48 hours and 72 hours post-prep application |
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| Secondary | Safety as Assessed by Skin Irritation Scores Coded by Study Staff | For the conditions of erythema, edema, rash, and dryness, a rating of 0 (no reaction), 1 (mild and/or transient, limited to sensitive area), 2 (moderate, persisting over much of the product-exposed area), or 3 (severe, extending over most or all of the product-exposed area) was recorded on the Skin Irritation Rating form of the eCRF. | Data from the 48-hour and 72-hour timepoints were combined for each skin condition category of erythema, edema, rash and erythema since all ratings for all subjects at all timepoints were scored as zero (no reaction) for all subjects. | Posted | Mean | Standard Deviation | Score on a scale | 48 hours and 72 hours post-product application |
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| Secondary | Safety as Assessed by Adverse Events | Number of subjects with adverse events as self-reported or identified by study staff | Adverse event reports through the treatment period, that is both 48 and 72 hours post dose. | Posted | Count of Participants | Participants | To 72 hours post treatment |
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Adverse events were collected during the treatment phase of the study. The product remained on the skin for approximately 72 hours post.
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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 - Abdomen | Chlorhexidine (CHG) 2% / Isopropyl alcohol (IPA) 70% 3M CHG/IPA Surgical Skin Preparation: Chlorhexidine gluconate 2% / Isopropyl alcohol 70% Applied to the abdominal area | 0 | 25 | 0 | 25 | 0 | 25 |
| EG001 | Normal Saline - Abdomen | 0.9% sodium chloride with applicator Normal Saline: 0.9% sodium chloride applied with foam applicator Applied to the abdominal area | 0 | 25 | 0 | 25 | 0 | 25 |
| EG002 | 3M CHG/IPA - Inguinal | Chlorhexidine (CHG) 2% / Isopropyl alcohol (IPA) 70% 3M CHG/IPA Surgical Skin Preparation: Chlorhexidine gluconate 2% / Isopropyl alcohol 70% Applied to the inguinal area | 0 | 23 | 0 | 23 | 0 | 23 |
| EG003 | Normal Saline - Inguinal | 0.9% sodium chloride with applicator Normal Saline: 0.9% sodium chloride applied with foam applicator Applied to the inguinal area | 0 | 23 | 0 | 23 | 0 | 23 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nancy Klinger | 3M | 651 491 9433 | nmklinger@mmm.com |
| >=66 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or not reported |
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| 72-hour timepoint |
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| 48 hours post treatment. The primary analysis used a modified intent to treat population. Subjects were excluded who did not meet the treatment day baseline requirement of greater than or equal to 3.0 log10 CFU/cm^2 on the groin. The null hypothesis is that there is no difference in log10 CFU/cm^2 recovery between arms. | Paired t-test | 0.0001 | Mean Difference (Final Values) | 2.37 | Standard Error of the Mean | 0.29 | 2-Sided | 95 | 0.60 | 5.75 | Superiority |
| 72 hours post treatment. The primary analysis used a modified intent to treat population. Subjects were excluded who did not meet the treatment day baseline requirement of greater than or equal to 3.0 log10 CFUcm2 on the groin. The null hypothesis is that there is no difference in log10 CFU/cm^2 recovery between arms. | Paired t-test | 0.0001 | Mean Difference (Final Values) | 1.51 | Standard Error of the Mean | 0.23 | 2-Sided | 95 | 0.17 | 3.75 | Superiority |
| 72 hours post treatment. The primary analysis used a modified intent to treat population. Subjects were excluded who did not meet the treatment day baseline requirement of greater than or equal to 3.0 log10 CFUcm2 on the groin. The null hypothesis is that there is no difference in log10 CFU/cm^2 recovery between arms. | Paired t-test | 0.0001 | Mean Difference (Final Values) | 2.40 | Standard Error of the Mean | 0.33 | 2-Sided | 95 | 0.13 | 5.04 | Superiority |
| OG003 | Normal Saline - Inguinal Area | 0.9% sodium chloride with applicator Normal Saline: 0.9% sodium chloride applied with foam applicator |
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