Multicenter Trial of Daily Chlorhexidine Bathing to Reduce Nosocomial Infections

MRSA Colonization Clinical Trial

— CBET  

Official title:

Multicenter Evaluation of The Effectiveness of Source Control With Daily Chlorhexidine Skin Preparation in Reducing Nosocomial Infections Including MRSA and VRE

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00502476
• Other study ID #: CI06-003
• Status: Recruiting
• Phase: N/A
• First received: July 16, 2007
• Last updated: August 6, 2007
• Start date: August 2007
• Est. completion date: September 2009

Study information

• Verified date: August 2007
• Source: Hunter Holmes Mcguire Veteran Affairs Medical Center
• Contact: Michael W Climo, MD
• Phone: (804) 675-5018
• Email: michael.climo[@]va.gov
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14000
• Est. completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Bacteremia
• Communicable Diseases
• Cross Infection
• Infection
• MRSA Colonization
• MRSA Infection
• Nosocomial Bacteremia
• VRE Colonization
• VRE Infection

Intervention

Procedure:
• Bathing with Chlorhexidine Impregnated Washcloths

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Hunter Holmes McGuire Veteran Affairs Medical Center	Richmond	Virginia
United States	Barnes Jewish Hospital	St. Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Hunter Holmes Mcguire Veteran Affairs Medical Center	Centers for Disease Control and Prevention, Sage Products, Inc.

Country where clinical trial is conducted

United States,