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Determine the antimicrobial properties of a proposed new product and an already approved product and a placebo (no drug). Study will be conducted using methods dictated by the FDA.
Determine the antimicrobial properties of a proposed new product and an already approved product and a placebo (no drug). Study will be conducted using methods dictated by the FDA.
This study uses topical sampling from the abdomen and the groin on intact skin and evaluates the germs left on the skin after treatment with the proposed new product, the currently approved product and the placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHG 2%-26 ml | Experimental | Chlorhexidine gluconate in an aqueous base, 26 ml applicator |
|
| ChloraPrep 26 ml | Active Comparator | ChloraPrep One-Step 26 ml Active drug contains chlorhexidine gluconate and alcohol |
|
| Sterile Saline | Placebo Comparator | Sterile salt water administered topically. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine gluconate | Drug | Chlorhexidine gluconate (2% w/v) in an aqueous base, 26 ml applicator. Active drug contains alcohol and the placebo contains no drug. Administered topically. |
| Measure | Description | Time Frame |
|---|---|---|
| 3.0 log10 reduction in CFU/cm2 on inguinal sites, and 2.0 log10 reduction in CFU/cm2 on abdominal sites | 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 |
|---|---|---|
| Daryl S Paulsen, PhD | President and CEO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioScience Laboratories | Bozeman | Montana | 59715 | United States |
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| ID | Term |
|---|---|
| C010882 | chlorhexidine gluconate |
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| ChloraPrep One Step | Drug | Administer topically |
|
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| Sterile saline | Drug | 0.9% NaCl solution |
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