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| Name | Class |
|---|---|
| 3M | INDUSTRY |
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The purpose of this study is to determine the antimicrobial efficacy of an investigational CHG/IPA prep on skin flora of the inguinal regions of human subjects.
Non-inferiority of the investigational product to the FDA-approved active control for log10/cm2 recovery of skin flora relative to Treatment Day baseline log10/cm2 on the inguinal region at 10 minutes following application. Non-inferiority is based on a non-inferiority margin of 0.5 log10/cm2.
Superiority of the active products to the negative control for log10/cm2 recovery of skin flora relative to Treatment Day baseline log10/cm2 on the inguinal region at 10 minutes following application. A superiority margin of 1.2 log10/cm2 is used.
Number of observations for which the log10/cm2 recovery of skin flora on the inguinal region at 6 hours following application of the study products is higher than treatment day log10/cm2 baseline skin flora.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHG/IPA Surgical skin preparation | Experimental | Apply topically to the inguinal region for 2 minutes |
|
| CHG/IPA Film-Forming Surgical skin preparation | Active Comparator | Apply topically to the inguinal region for 2 minutes |
|
| Normal saline | Placebo Comparator | Apply topically to the inguinal region for 2 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHG/IPA Surgical skin preparation | Drug | Apply topically to the inguinal region for 2 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Log Change (Reduction) in Skin Flora on the Inguinal Region at 10 Minutes | Immediate efficacy endpoint which is defined as the average treatment effect (ATE) log10 CFU/cm2 of skin flora on the inguinal region at 10 minutes following application of the study products relative to the treatment day baseline skin flora | 10 minutes |
| Log Change (Reduction) in Skin Flora on the Inguinal Region at 6 Hours | Persistent efficacy endpoint which is a binary endpoint with success/failure, where "success" is defined as log10 CFU/cm2 of skin flora on the inguinal region at 6 hours following application of the study products being lower than the treatment day baseline skin flora | 6 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Muhammad H Bashir, MD, CCRP | Microbac | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Microbac Laboratories, Inc | Sterling | Virginia | 20164 | United States |
This is a randomized, paired-comparison design where each subject received two of the planned treatments, one on the left side and one on the right. Each subject provided two inguinal test sites, left and right. 154 subjects were randomized for the inguinal region resulting in 308 applications of test products.
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| ID | Title | Description |
|---|---|---|
| FG000 | CHG/IPA Surgical Skin Preparation | Apply topically to the inguinal region for 2 minutes |
| FG001 | CHG/IPA Film-Forming Surgical Skin Preparation | Apply topically to the inguinal region for 2 minutes |
| FG002 | Normal Saline | Apply 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 5.00 log10 CFU/cm^2 bilaterally on the inguinal region were included in the analysis.
| ID | Title | Description |
|---|---|---|
| BG000 | CHG/IPA Surgical Skin Preparation | Apply topically to the inguinal region for 2 minutes |
| BG001 | CHG/IPA Film-Forming Surgical Skin Preparation | Apply topically to the inguinal region for 2 minutes |
| 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 | Log Change (Reduction) in Skin Flora on the Inguinal Region at 10 Minutes | Immediate efficacy endpoint which is defined as the average treatment effect (ATE) log10 CFU/cm2 of skin flora on the inguinal region at 10 minutes following application of the study products relative to the treatment day baseline skin flora | 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 5.00 log10/cm^2 on the inguinal test site. The number treatment arm-specific test sites is equal to the number of participants. | Posted | Mean | Standard Deviation | Log10 CFU/cm^2 | 10 minutes |
|
Adverse events were collected on treatment day, an average of 6-7 hours per participant. 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 | CHG/IPA Surgical Skin Preparation | Apply topically to the inguinal region for 2 minutes |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Linda Olson | 3M | 651-736-3586 | lkolson2@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: Combined Protocol and Statistical Analysis Plan | May 27, 2020 | May 22, 2023 | Prot_SAP_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Detailed Statistical Analysis Plan | Mar 31, 2020 | May 22, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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|
| Normal saline | Drug | Apply topically to the inguinal region for 2 minutes |
|
|
| BG002 | Normal Saline | Apply topically to the inguinal region for 2 minutes |
| BG003 | Total | Total of all reporting groups |
| Test sites on skin |
|
| Test sites on skin |
| Test sites on skin |
|
| Sex/Gender, Customized | Number | Test sites on skin | Test sites on skin |
|
| Race/Ethnicity, Customized | Number | Test sites on skin | Test sites on skin |
|
| Region of Enrollment | Number | Test sites on skin | Test sites on skin |
|
| CHG/IPA Film-Forming Surgical Skin Preparation: |
Apply topically to the inguinal region for 2 minutes |
| OG002 | Normal Saline | Apply topically to the inguinal region for 2 minutes |
|
|
| Primary | Log Change (Reduction) in Skin Flora on the Inguinal Region at 6 Hours | Persistent efficacy endpoint which is a binary endpoint with success/failure, where "success" is defined as log10 CFU/cm2 of skin flora on the inguinal region at 6 hours following application of the study products being lower than the treatment day baseline skin flora | 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 5.00 log10/cm^2 on the inguinal test site. The number treatment arm-specific test sites is equal to the number of participants. | Posted | Mean | Standard Deviation | Log10 CFU/cm^2 | 6 hours |
|
|
|
| 0 |
| 135 |
| 0 |
| 135 |
| 0 |
| 135 |
| EG001 | CHG/IPA Film-Forming Surgical Skin Preparation | Apply topically to the inguinal region for 2 minutes | 0 | 135 | 0 | 135 | 0 | 135 |
| EG002 | Normal Saline | Apply topically to the inguinal region for 2 minutes | 0 | 38 | 0 | 38 | 0 | 38 |
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| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |