Multicenter Trial of Daily Chlorhexidine Bathing to Reduce Nosocomial Infections

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

14000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-08-31

Study Completion Date

2009-09-30

Brief Summary

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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

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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.

Conditions

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Nosocomial Bacteremia MRSA Colonization MRSA Infection VRE Colonization VRE Infection

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Interventions

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Bathing with Chlorhexidine Impregnated Washcloths

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Michael W Climo, MD

Role: STUDY_DIRECTOR

Hunter Holmes Mcguire Veteran Affairs Medical Center

Edward S Wong, MD

Role: PRINCIPAL_INVESTIGATOR

Hunter Holmes Mcguire Veteran Affairs Medical Center

Jane A Cecil, MD

Role: PRINCIPAL_INVESTIGATOR

Hunter Holmes Mcguire Veteran Affairs Medical Center

Kent Sepkowitz, MD

Role: PRINCIPAL_INVESTIGATOR

Weil Medical College of Cornell University

Trish M Perl, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Debbie Yokoe, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Harvard School of Medicine, Brigham and Women's Hospital

Maureen Bolon, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University Feinberg School of Medicine

Dave K Warren, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Loreen Herwaldt, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

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