The Impact of Chlorhexidine-Based Bathing on Nosocomial Infections

MRSA Colonization Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00448942
• Other study ID #: 01115
• Secondary ID: UR8/CCU315346-03
• Status: Completed
• Phase: N/A
• First received: March 15, 2007
• Last updated: March 15, 2007
• Start date: November 2004
• Est. completion date: January 2006

Study information

• Verified date: March 2007
• Source: Hunter Holmes Mcguire Veteran Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5300
• Est. completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Daily bathing with Chlorhexidine based product

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland
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 (6)

Lead Sponsor	Collaborator
Hunter Holmes Mcguire Veteran Affairs Medical Center	Centers for Disease Control and Prevention, Johns Hopkins University, University of Tennessee, Washington University School of Medicine, Weill Medical College of Cornell University

Country where clinical trial is conducted

United States,