Clinical trial NCT00502476: Multicenter Trial of Daily Chlorhexidine Bathing to Reduce Nosocomial Infections
Official title: Multicenter Evaluation of The Effectiveness of Source Control With Daily Chlorhexidine Skin Preparation in Reducing Nosocomial Infections Including MRSA and VRE
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nosocomial Bacteremia
MRSA Colonization
MRSA Infection
VRE Colonization
VRE Infection
Keywords: MRSA
VRE
BSI
Lead sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center
Sponsor class: FED
Collaborators: name: Centers for Disease Control and Prevention
name: Sage Products, Inc.
First posted: 2007-07-17
Enrollment: 14000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: St. Louis
country: United States
facility: Barnes Jewish Hospital
state: Missouri
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: Richmond
country: United States
facility: Hunter Holmes McGuire Veteran Affairs Medical Center
state: Virginia
Study officials:
affiliation: Hunter Holmes Mcguire Veteran Affairs Medical Center
name: Michael W Climo, MD
role: STUDY_DIRECTOR
affiliation: Hunter Holmes Mcguire Veteran Affairs Medical Center
name: Edward S Wong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hunter Holmes Mcguire Veteran Affairs Medical Center
name: Jane A Cecil, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Weil Medical College of Cornell University
name: Kent Sepkowitz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Trish M Perl, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard School of Medicine, Brigham and Women's Hospital
name: Debbie Yokoe, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University Feinberg School of Medicine
name: Maureen Bolon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Dave K Warren, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Iowa
name: Loreen Herwaldt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.