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Multicenter Trial of Daily Chlorhexidine Bathing to Reduce Nosocomial Infections (CBET)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by Hunter Holmes Mcguire Veteran Affairs Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Sage Products, Inc.
Information provided by:
Hunter Holmes Mcguire Veteran Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT00502476
First received: July 16, 2007
Last updated: August 6, 2007
Last verified: August 2007

July 16, 2007
August 6, 2007
August 2007
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Complete list of historical versions of study NCT00502476 on ClinicalTrials.gov Archive Site
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Multicenter Trial of Daily Chlorhexidine Bathing to Reduce Nosocomial Infections
Multicenter Evaluation of The Effectiveness of Source Control With Daily Chlorhexidine Skin Preparation in Reducing Nosocomial Infections Including MRSA and VRE

To determine if daily bathing with chlorhexidine impregnated washcloths will reduce the incidence of MRSA and VRE within an Intensive Care Unit (ICU) or ward setting.

This is a cluster randomized, crossover-controlled trial with wards as the units of randomization. The trial will predominantly take place in ICU's but may include any acute care ward that has active surveillance for MRSA and or VRE in place (i.e., Bone Marrow transplant units, Oncology wards, etc.) Units will be randomly assigned to utilize two bathing routines in a random order. Each bathing routine will be utilized on all admitted patients to the unit for a six month study period for a total study duration of 12 months. The two bathing routines will include either the use of the Comfort® Bath Washcloth System (control) or the use of 2% Chlorhexidine Gluconate Cloth. Randomized units will either start with 2% Chlorhexidine Gluconate Cloth for six months and then switch to Comfort™ Bath Washcloth for the remaining six month period or the reverse order. Data collection will include all surveillance and clinical cultures for MRSA and or VRE and all bloodstream infections.

Observational
Observational Model: Defined Population
Time Perspective: Longitudinal
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  • Nosocomial Bacteremia
  • MRSA Colonization
  • MRSA Infection
  • VRE Colonization
  • VRE Infection
Procedure: Bathing with Chlorhexidine Impregnated Washcloths
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Climo MW, Yokoe DS, Warren DK, Perl TM, Bolon M, Herwaldt LA, Weinstein RA, Sepkowitz KA, Jernigan JA, Sanogo K, Wong ES. Effect of daily chlorhexidine bathing on hospital-acquired infection. N Engl J Med. 2013 Feb 7;368(6):533-42. doi: 10.1056/NEJMoa1113849.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
14000
September 2009
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Inclusion Criteria:

  • All patients admitted to study units during the proposed study interval are eligible for inclusion in the study

Exclusion Criteria:

  • Patients with known allergies to chlorhexidine gluconate or any other ingredients in the product
  • Patients with burns that include a high percentage of disrupted body surface area
  • Use in patients undergoing lumbar punctures or contact with the meninges
  • Patients with large open skin wounds; and
  • Children less than 18 years old
Both
18 Years and older
No
Contact: Michael W Climo, MD (804) 675-5018 michael.climo@va.gov
Contact: Edward S Wong, MD (804) 675-6792 edward.wong@va.gov
United States
 
NCT00502476
CI06-003
No
Not Provided
Hunter Holmes Mcguire Veteran Affairs Medical Center
  • Centers for Disease Control and Prevention
  • Sage Products, Inc.
Study Director: Michael W Climo, MD Hunter Holmes Mcguire Veteran Affairs Medical Center
Principal Investigator: Edward S Wong, MD Hunter Holmes Mcguire Veteran Affairs Medical Center
Principal Investigator: Jane A Cecil, MD Hunter Holmes Mcguire Veteran Affairs Medical Center
Principal Investigator: Kent Sepkowitz, MD Weil Medical College of Cornell University
Principal Investigator: Trish M Perl, MD, MSc Johns Hopkins University
Principal Investigator: Debbie Yokoe, MD, MPH Harvard School of Medicine, Brigham and Women's Hospital
Principal Investigator: Maureen Bolon, MD Northwestern University Feinberg School of Medicine
Principal Investigator: Dave K Warren, MD Washington University School of Medicine
Principal Investigator: Loreen Herwaldt, MD University of Iowa
Hunter Holmes Mcguire Veteran Affairs Medical Center
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP