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Compare 2 application techniques of ChloraPrep Swabstick--3 swabsticks at once versus 3 swabsticks used sequentially. Hibiclens applied according to the manufacturer's directions. Sterile swabsticks (wetted with sterile deionizd water) applied using the same method as the ChloraPrep Swabstick.
Determine differences (if any) in 2 different application techniques of ChloraPrep Swabstick--3 swabsticks at once versus 3 swabsticks used sequentially. Hibiclens, a liquid antibacterial soap, applied according to the manufacturer's directions as a active/positive comparison. Sterile swabsticks (wetted with sterile deionized water) applied as a negative comparison using the same method as the ChloraPrep swabstick.
Study uses topical sampling from the abdomen and the groin on intact skin and evaluates the germs left on the skin after treatment with ChloraPrep Swabsticks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHG Swabstick (3 @ once) | Experimental | Chlorhexidine gluconate (CHG) 2% w/v CHG/isopropyl alcohol (IPA) 70% v/v - 3 swabsticks applied @ same time |
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| CHG Swabstick sequential | Experimental | Chlorhexidine gluconate (CHG) 2% w/v and isopropyl alcohol (IPA) 70% v/v - 3 swabsticks applied sequentially |
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| Hibiclens | Active Comparator | Chlorhexidine gluconate (CHG) 4% w/v in an aqueous base |
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| Sterile water swab (3 @ once) | Placebo Comparator | Sterile swabstick wetted with sterile deionized water - 3 swabsticks applied at the same time. |
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| Sterile water swabstick (sequential) | Placebo Comparator | Sterile swabstick wetted with sterile water--3 swabsticks applied sequentially. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHG 2% w/v & IPA 70% v/v, swabstick (3 @ once). | Drug | 3 swabsticks topically applied at the same time to intact skin |
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| Measure | Description | Time Frame |
|---|---|---|
| log10 Reductions From Baseline for Each Test Parameter in CFU (Colony Forming Unit)/cm2 on Inguinal and Abdominal Sites | The bacterial reductions achieved by the test products and the controls using 2 different application techniques at 10-minute and 6-hour sampling intervals for both groin and abdominal sites were evaluated. | 10 minutes and 6 hours after application of test solutions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| M. Hamid Bashir, MD | Medical Director | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Microbiotest | Sterling | Virginia | 20164 | United States |
Each subject received more than one treatment. Randomization was done by testing site and each subject had 4 testing sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | Study Participants that were treated |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Aug 24, 2007 |
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| CHG 2% w/v & IPA 70% v/v swab applied sequentially | Drug | Chlorhexidine gluconate 2% w/v and isopropyl alcohol 70% v/v; 3 swabsticks applied sequentially to intact skin. |
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| Aqueous CHG 4% w/v applied according to mfr's directions | Drug | Chlorhexidine gluconate 4% w/v in an aqueous base applied according to mfr's directions. Step 1) 5 ml of Hibiclens applied to a sterile gauze pad. Step 2) Product applied to treatment area on intact skin for 2 minutes. Area dried with sterile towel or sterile gauze. Steps 1 and 2 repeated. |
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| Sterile swabstick with sterile water (3 @ once) | Other | 3 sterile swabsticks wetted with sterile water topically applied to intact skin at the same time. |
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| Sterile swabstick with sterile water (one-at-a-time) | Other | Sterile swabsticks wetted with sterile water topically applied to intact skin one-at-a-time. |
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| CHG Swabstick (3 @ Once) |
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| CHG Swabstick Sequential |
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| Hibiclens |
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| Sterile Water Swab (3 @ Once) |
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| Sterile Water Swabstick (Sequential) |
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| COMPLETED |
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| NOT COMPLETED |
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Participants treated in the study with adequate baseline bacterial load.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All Participants Who Completed Evaluations |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 371-121 Preoperative Skin Preparations | Note: Participants received 2 of the 5 study products. One product is applied to on the left abdomen and groin and one product is applied on the right abdomen and groin. | Count of 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | log10 Reductions From Baseline for Each Test Parameter in CFU (Colony Forming Unit)/cm2 on Inguinal and Abdominal Sites | The bacterial reductions achieved by the test products and the controls using 2 different application techniques at 10-minute and 6-hour sampling intervals for both groin and abdominal sites were evaluated. | Measure Analysis Population Description: Number analyzed is not equal to participants treated but rather equal to the number of treated sites for individuals who met the baseline bacterial load criteria on treatment day | Posted | Mean | Standard Deviation | Average log10 reductions in CFU/cm2 | 10 minutes and 6 hours after application of test solutions | Number of Sites Analyzed | Number of Sites Analyzed |
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During the study through the 6-hour time point evaluations
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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 Swabstick (3 @ Once) | Chlorhexidine gluconate (CHG) 2% CHG/isopropyl alcohol (IPA) 70%-3 swabsticks applied @ same time CHG 2% w/v & IPA 70% v/v, swabstick (3 @ once): 3 swabsticks topically applied at the same time to intact skin | 0 | 139 | 0 | 139 | 0 | 139 |
| EG001 | CHG Swabstick Sequential | Chlorhexidine gluconate (CHG) 2% w/v and isopropyl alcohol (IPA) 70% v/v--3 swabsticks applied sequentially CHG 2% w/v & IPA 70% v/v swabstick: 3 swabsticks applied sequentially to intact skin. | 0 | 138 | 0 | 138 | 0 | 138 |
| EG002 | Hibiclens | Chlorhexidine gluconate 4% w/v in an aqueous base Aqueous CHG 4% w/v applied according to manufacturer's directions: Step 1) 5 mL of Hibiclens applied to a sterile gauze pad. Step 2) Product applied to treatment area on intact skin for 2 minutes. Area dried with sterile towel or sterile gauze. Steps 1 and 2 repeated. | 0 | 133 | 0 | 133 | 0 | 133 |
| EG003 | Sterile Water Swab (3 @ Once) | Sterile swabstick wetted with sterile deionized water--3 swabsticks applied at the same time. Sterile swabstick with sterile deionized water (3 @ once): 3 swabsticks wetted with sterile water topically applied to intact skin at the same time. | 0 | 132 | 0 | 132 | 0 | 132 |
| EG004 | Sterile Water Swabstick (Sequential) | Sterile swabstick wetted with sterile deionized water--3 swabsticks applied sequentially. Sterile swabstick with sterile deionized water (sequentially): swabsticks wetted with sterile water topically applied to intact skin sequentially. | 0 | 126 | 0 | 126 | 0 | 126 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Erin Zook | BD | 847-362-9047 | erin.zook@bd.com |
| Oct 28, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D002864 | Chromogranins |
| C010882 | chlorhexidine gluconate |
| ID | Term |
|---|---|
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
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| Hibiclens |
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| Sterile Water Swab (3 @ Once) |
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| Sterile Water Swabstick (Sequential) |
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| Number of Sites Analyzed |
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| Groin site - 6 hours |
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| Abdomen site - 10 minutes |
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| Abdomen site - 6 hours |
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