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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CareFusion
ClinicalTrials.gov Identifier:
NCT00692484
First received: June 4, 2008
Last updated: March 21, 2013
Last verified: March 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: CareFusion
ClinicalTrials.gov Identifier: NCT00692484     History of Changes
Other Study ID Numbers: 060629
Study First Received: June 4, 2008
Last Updated: March 21, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by CareFusion:
Antimicrobial
Antisepsis
Topical antisepsis

Additional relevant MeSH terms:
Povidone-Iodine
Chlorhexidine gluconate
Chlorhexidine
Anti-Infective Agents
Povidone
Anti-Infective Agents, Local
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents
Disinfectants
Plasma Substitutes
Blood Substitutes
Hematologic Agents

ClinicalTrials.gov processed this record on October 19, 2014