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Sponsored by: |
Enturia |
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Information provided by: | Enturia |
ClinicalTrials.gov Identifier: | NCT00692484 |
Evaluate effect of application procedure on efficacy of 2 antiseptics for cleaning skin prior to surgery.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: Chlorhexidine gluconate Drug: Povidone iodine |
Phase III |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Pilot Evaluation of the Effect of Application Procedure on the Antimicrobial Effects of an Aqueous CHG and a Traditional Iodophor Scrub Paint |
Enrollment: | 25 |
Study Start Date: | October 2007 |
Study Completion Date: | February 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Chlorhexidine gluconate 2%
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Drug: Chlorhexidine gluconate
Chlorhexidine gluconate (2% w/v) in an aqueous base. Administered topically.
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2: Active Comparator
Povidone iodine scrub and paint
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Drug: Povidone iodine
Povidone iodine scrub and paint. Administer topically.
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Evaluate the effect of application procedure on the antimicrobial properties of a new product and a currently marketed product. Study will be conducted using methods dictated by the FDA.
Study uses topical sampling from the abdomen and groin on intact skin and evaluates the germs. Effects of blotting versus not blotting will be assessed.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Enturia, Inc. ( Cynthia Crosby, Vice President, Medical Affairs ) |
Study ID Numbers: | 060629 |
Study First Received: | June 4, 2008 |
Last Updated: | June 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00692484 |
Health Authority: | United States: Food and Drug Administration |
Antimicrobial Antisepsis Topical antisepsis |
Chlorhexidine Chlorhexidine gluconate Povidone |
Iodine Povidone-Iodine Healthy |
Anti-Infective Agents Anti-Infective Agents, Local Disinfectants Therapeutic Uses Hematologic Agents |
Blood Substitutes Plasma Substitutes Dermatologic Agents Pharmacologic Actions |