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Preoperative Skin Preparation Evaluation

This study has been completed.
Sponsor:
Information provided by:
CareFusion
ClinicalTrials.gov Identifier:
NCT00636480
First received: March 11, 2008
Last updated: February 19, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Topical Antisepsis
 Drug: Chlorhexidine gluconate
Drug: ChloraPrep One Step
Drug: Sterile saline
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Preoperative Skin Preparation Evaluation of One Test Product With a Positive and a Negative Control

Resource links provided by NLM:

U.S. FDA Resources

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 ]

Enrollment: 60
Study Start Date: October 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CHG 2%-26 ml
Chlorhexidine gluconate in an aqueous base, 26 ml applicator
 Drug: Chlorhexidine gluconate
Chlorhexidine gluconate (2% w/v) in an aqueous base, 26 ml applicator. Active drug contains alcohol and the placebo contains no drug. Administered topically.
Other Name: ChloraPrep AQ
Active Comparator: ChloraPrep 26 ml
ChloraPrep One-Step 26 ml Active drug contains chlorhexidine gluconate and alcohol
 Drug: ChloraPrep One Step
Administer topically
Other Name: Chlorhexidine gluconate 2% w/v and 70% v/v isopropyl alcohol
Placebo Comparator: Sterile Saline
Sterile salt water administered topically.
 Drug: Sterile saline
0.9% NaCl solution
Other Name: Physiologic saline (0.9% NaCl)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Free of dermatoses, cuts, lesions, or other skin disorders on or around the test sites; no exposure to topical or systemic antimicrobials, antibiotics, or steroids (other than contraceptives, for the fourteen (14) day pre-test conditioning period and must 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 fourteen(14) day pre-test conditioning period or during the test period;
  • Exposure of the test sites to strong detergent, solvents, or other irritants during the fourteen (14) day pre-test conditioning period or during the test period;
  • Use of systemic or topical antibiotic medications, steroid medications other than contraceptives, or any other product known to affect the normal microbial flora of the skin during the fourteen ()14) day pre-test conditioning period or during the test period;
  • Know of allergies to vinyl, latex (rubber), alcohols, metals, inks, or tape adhesives, or to common antibacterial agents found in soaps, lotions, or ointments, particularly chlorhexidine gluconate, and/or isopropyl alcohol;
  • A medical diagnosis of a physical condition, such as a current or recent severe illness, asthma, diabetes, hepatitis, an organ transplant, any immunocompromised conditions such as AIDS (or HIV positive), mitral valve prolapse, or a requirement to take antibiotics prior to dental procedures;
  • Pregnancy, plans to become pregnant within the pre-test and test periods of the study, or nursing a child;
  • Any active skin rashes or breaks in the skin of the test sites;
  • A currently active skin disease or inflammatory skin condition, including contact dermatitis; showering or bathing within the seventy-two (72) hour period prior to sampling; participation in another clinical study in the past thirty (30) days or current participation in another clinical study;
  • Any medical condition or use of any medications, that, in the opinion of the Study Director, should preclude participation;
  • Unwillingness to fulfill the performance requirements of the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00636480

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: Jolene Mason, Senior Director, Clinical Research, Enturia, Inc
ClinicalTrials.gov Identifier: NCT00636480     History of Changes
Other Study ID Numbers: 070921-103
Study First Received: March 11, 2008
Last Updated: February 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by CareFusion:
Antimicrobial
Antisepsis

Additional relevant MeSH terms:
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
 Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on June 18, 2013