Multicenter Trial of Daily Chlorhexidine Bathing to Reduce Nosocomial Infections

• Conditions: Nosocomial Bacteremia; MRSA Colonization; MRSA Infection; VRE Colonization; VRE Infection

• Registration Number: NCT00502476
• Lead Sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2007-07-16
• Study First Submitted QC: 2007-07-16
• Study First Posted: 2007-07-17
• Status Verified: 2007-08
• Study Start: 2007-08
• Last Update Submitted: 2007-08-06
• Last Update Posted: 2007-08-07
• Study Completion: 2009-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 14000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (7)

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States

Barnes Jewish Hospital; 🇺🇸 St. Louis, Missouri, United States

Hunter Holmes McGuire Veteran Affairs Medical Center; 🇺🇸 Richmond, Virginia, United States

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States