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Pilot Evaluation of the Application Procedure on the Antimicrobial Effects of 2 Antiseptics

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00692484
First Posted: June 6, 2008
Last Update Posted: April 1, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
CareFusion
  Purpose
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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Pilot Evaluation of the Effect of Application Procedure on the Antimicrobial Effects of an Aqueous CHG and a Traditional Iodophor Scrub Paint

Resource links provided by NLM:


Further study details as provided by CareFusion:

Primary Outcome Measures:
  • 3.0 log10 reduction in CFU/cm2 on inguinal sites, and 2.0 log10 reduction in CFU/cm2 on abdominal sites [ Time Frame: 10 minutes and 6 hours after application of test solutions ]

Secondary Outcome Measures:
  • Impact of blotting versus not blotting [ Time Frame: Blotting and not blotting after 2 minute application with CHG and 5 minute application of iodophor ]

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
Experimental: 1
Chlorhexidine gluconate 2%
Drug: Chlorhexidine gluconate
Chlorhexidine gluconate (2% w/v) in an aqueous base. Administered topically.
Other Name: ChloraPrep AQ
Active Comparator: 2
Povidone iodine scrub and paint
Drug: Povidone iodine
Povidone iodine scrub and paint. Administer topically.
Other Name: Betadine

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Free of dermatoses, cuts, lesions, or other skin disorders around test sites
  • must not have received topical or systemic antimicrobials, antibiotics, or steroids for 7 days prior to testing and agree to abstain from these materials until completion of the study

Exclusion Criteria:

  • Exposure of test sites to antimicrobial agents, medicated soaps, medicated shampoos, or medicated lotions, use of biocide-treated pools or hot tubs, use of tanning beds, or sunbathing during the 7 day pre-test period or during the test period
  • exposure of the test sites to strong detergents, solvents, or other irritants during the 7 day pre-test period or during the test period
  • use of systemic or topical antibiotic medications, steroid medications, or any other product known to affect the normal microbial flora of the skin during the 7 day pre-test period or during the test period
  • known allergy to latex (rubber), alcohols, inks, or tape adhesives, or to common antibacterial agents found in soaps, lotions, or ointments, particularly chlorhexidine gluconate and povidone iodine
  • active skin rashes or breaks in the skin of the test sites
  • currently active skin disease or inflammatory skin condition, including contact dermatitis
  • showering or bathing within the 72 hour period prior to sampling
  • participation in a clinical study in the past 7 days or current participation in another clinical study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00692484


Locations
United States, Montana
BioScience Laboratories
Bozeman, Montana, United States, 59715
Sponsors and Collaborators
CareFusion
Investigators
Principal Investigator: Daryl S Paulsen, PhD President and CEO
  More Information

Responsible Party: CareFusion
ClinicalTrials.gov Identifier: NCT00692484     History of Changes
Other Study ID Numbers: 060629
First Submitted: June 4, 2008
First Posted: June 6, 2008
Last Update Posted: April 1, 2013
Last Verified: March 2013

Keywords provided by CareFusion:
Antimicrobial
Antisepsis
Topical antisepsis

Additional relevant MeSH terms:
Chlorhexidine
Chlorhexidine gluconate
Iodine
Povidone-Iodine
Anti-Infective Agents
Anti-Bacterial Agents
Povidone
Anti-Infective Agents, Local
Disinfectants
Dermatologic Agents
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Plasma Substitutes
Blood Substitutes