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| Name | Class |
|---|---|
| 3M | INDUSTRY |
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This study evaluates reduction of resident flora produced by the test product within a defined prepped area of skin.
Three different sample sites within a defined prepped area of skin were collected to determine whether reductions in resident flora produced by the test product are consistent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3M CHG/IPA Prep / Center | Experimental | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% solution applied topically to intact skin; sample collected from center test site on skin in application area. |
|
| 3M CHG/IPA Prep / Mid-peripheral | Experimental | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% solution applied topically to intact skin; sample collected from mid-peripheral test site on skin in application area. |
|
| 3M CHG/IPA Prep / Peripheral | Experimental | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% solution applied topically to intact skin; sample collected from peripheral test site on skin in application area. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3M CHG/IPA Prep | Drug | Apply topically to intact skin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Log Change of Skin Flora Relative to Pre-treatment (Baseline) in Each of 3 Sampling Sites at a Defined Post-treatment Sampling Time. | The primary measure of efficacy is change in skin flora log10 CFU/cm^2 in each of the skin sampling sites relative to baseline skin flora log10 CFU/cm^2. Baseline samples must satisfy the greater than or equal to 3.0 in each of the sampling sites, to be used for data analysis. | Post-treatment sampling randomized as 10-minute or 13-minute post-product application |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety Outcome Evaluated by Skin Irritation Assessment | Skin irritation (dryness, edema, erythema, rash) assessed on the test sites using a 0-3 rating scale: 0 = no reaction, 1 = mild reaction, 2 = moderate reaction, 3 = severe reaction. | Assessed pre-treatment (baseline) and post-treatment (10 or 13 minutes) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rozalia Olsavszky, MD | Eurofins/Evic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurofins Evic Romania/S.C. BIO HIGH TECH S.R.L. | Bucharest | 040256 | Romania |
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| ID | Title | Description |
|---|---|---|
| FG000 | 3M CHG/IPA Prep | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% solution applied topically to intact skin; samples collected from center, mid-periphery, and periphery of test site on skin in application area. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 3M CHG/IPA Prep / Center | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% solution applied topically to intact skin; sample collected from center test site on skin in application area. |
| 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 | Comparison of Log Change of Skin Flora Relative to Pre-treatment (Baseline) in Each of 3 Sampling Sites at a Defined Post-treatment Sampling Time. | The primary measure of efficacy is change in skin flora log10 CFU/cm^2 in each of the skin sampling sites relative to baseline skin flora log10 CFU/cm^2. Baseline samples must satisfy the greater than or equal to 3.0 in each of the sampling sites, to be used for data analysis. | The primary analysis data set used a Modified Intent to Treat population: Subjects were excluded who did not meet the baseline requirement of greater than or equal to 3.0 log10 CFU/cm2 in all three sampling sites on the treatment site. The sampling time for efficacy evaluation was 10 minutes or 13 minutes post-product application as per the randomization schedule. | Posted | Mean | Standard Deviation | log10 CFU/cm^2 | Post-treatment sampling randomized as 10-minute or 13-minute post-product application | test sites on skin | test sites on skin |
|
Adverse events were collected during the treatment phase of the study. Treatment procedures required approximately 1 hour for each subject on the test day, and product remained on each subject's skin for approximately 13 to 16 minutes.
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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 / Center | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% solution applied topically to intact skin; sample collected from center test site on skin in application area. |
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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 | May 19, 2017 | Mar 12, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002864 | Chromogranins |
| C010882 | chlorhexidine gluconate |
| D000431 | Ethanol |
| D019840 | 2-Propanol |
| ID | Term |
|---|---|
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
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|
| Participants |
|
| Sex/Gender, Customized | Number | participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Evaluable Treatment Day Baseline Count | indicator for subjects with average treatment day baseline counts greater than or equal to 3.0 log10 colony forming units (CFU)/cm^2 on the 3 test sites (center, mid-peripheral and peripheral) in the treatment area. | Count of Participants | Participants |
|
Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% solution applied topically to intact skin; sample collected from center test site on skin in application area. |
| OG001 | 3M CHG /IPA Prep - Mid-peripheral | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% solution applied topically to intact skin; sample collected from mid-peripheral test site on skin in application area. |
| OG002 | 3M CHG/IPA Prep - Peripheral | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% solution applied topically to intact skin; sample collected from peripheral test site on skin in application area. |
|
|
|
| Other Pre-specified | Safety Outcome Evaluated by Skin Irritation Assessment | Skin irritation (dryness, edema, erythema, rash) assessed on the test sites using a 0-3 rating scale: 0 = no reaction, 1 = mild reaction, 2 = moderate reaction, 3 = severe reaction. | All treated subjects were considered evaluable for safety. Safety assessments were based on evaluations for skin reactions at the test sites. | Posted | Number | participants | Assessed pre-treatment (baseline) and post-treatment (10 or 13 minutes) |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | 3M CHG/IPA Mid-peripheral | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% solution applied topically to intact skin; sample collected from mid-peripheral test site on skin in application area. | 0 | 28 | 0 | 28 | 0 | 28 |
| EG002 | 3M CHG/IPA Peripheral | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% solution applied topically to intact skin; sample collected from peripheral test site on skin in application area. | 0 | 28 | 0 | 28 | 0 | 28 |
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| D000438 |
| Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
|
| Edema - pre-treatment rating = 0 |
|
| Edema - post-treatment rating = 0 |
|
| Erythema - pre-treatment rating = 0 |
|
| Erythema - post-treatment rating = 0 |
|
| Rash - pre-treatment rating = 0 |
|
| Rash - post-treatment rating = 0 |
|