Clinical trial NCT00448942: The Impact of Chlorhexidine-Based Bathing on Nosocomial Infections
Official title: The Impact of the Use of Chlorhexidine-Based Bathing System in the Hospital to Reduce the Incidence of MRSA/VRE Infection or Colonization and Nosocomial Bloodstream Infections (BSI)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nosocomial Bacteremia
Nosocomial Fungemia
MRSA Colonization
MRSA Infection
VRE Colonization
VRE Infection
Keywords: Staphylococcus aureus [B03.510.400.790.750.100]
Enterococcus faecalis [B03.510.400.800.280.280]
Enterococcus faecium [B03.510.400.800.280.300]
Bacteremia [C01.252.100]
Fungemia [C01.703.360]
Infection Control [G03.850.780.200.450]
Antisepsis [G03.850.780.200.450.150]
Lead sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center
Sponsor class: FED
Collaborators: name: Weill Medical College of Cornell University
name: Washington University School of Medicine
name: Johns Hopkins University
name: University of Tennessee
name: Centers for Disease Control and Prevention
First posted: 2007-03-19
Enrollment: 5300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: RETROSPECTIVE

Brief summary: The purpose of this study was to determine if the use of daily chlorhexidine bathing would decrease the incidence of MRSA and VRE colonization and healthcare associated Bloodstream Infections (BSI) among Intensive Care Unit (ICU) patients.

Detailed description: Infections due to Staphylococci including MRSA are the predominant nosocomially acquired complication in the intensive care unit. The increasing incidence of MRSA colonization and infection among ICU patients has been attributed to many factors including increased admission of patients already colonized with MRSA to the ICU, poor compliance with handwashing and barrier precautions, delayed identification of MRSA colonized patients, and understaffing. Measures that have proven to limit horizontal transmission between patients and staff and staff to patients include strict attention to barrier precautions and handwashing. Unfortunately both of these strategies require levels of compliance that are often not achieved.

Nosocomial blood stream infections are a leading source of morbidity and mortality among intensive care unit patients. Several modifiable factors have been shown to increase the risk of bloodstream infections. These include lapses in the use of strict sterile technique in the insertion of central venous catheters and improper site preparation. New CDC guidelines on the prevention of catheter related bloodstream infections recommend that the preferential use of chlorhexidine containing skin disinfectants be used for site preparation prior to insertion. The use of chlorhexidine reduces residual skin organisms as well as inhibits their rebound growth and has been demonstrated to reduce catheter-associated bloodstream infections in comparison to other skin disinfectant products such as povidone-iodine.

As a result of guidelines promoting the use of chlorhexidine, a number of intensive care units have implemented quality improvement projects examining the potential role of chlorhexidine based bathing of intensive care unit patients in reducing nosocomial transmission of multiresisitant organisms such as MRSA and vancomycin-resistant enterocooci (VRE). The goal of the currently proposed study is to analyse existing data from participating intensive care units that have adopted the use of chlorhexidine antisepsis to determine the impact of chlorhexidine on bacterial colonization and nosocomial infections Participating hospitals who have completed quality improvement projects that included the use of chlorhexidine in bathing of ICU patients will submit de-identified data on nosocomial bacteremias and MRSA and VRE colonization during defined time periods where chlorhexidine bathing was used in comparison to time periods where regular bathing procedures were utilized.

Eligibility criteria: Inclusion Criteria:

* All adult patients admitted to study units

Exclusion Criteria:

* Children under the age of 18
* Previous adverse reaction or documented allergy to chlorhexidine based products

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
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: Edward W Wong, MD
role: PRINCIPAL_INVESTIGATOR
References: