The Impact of Chlorhexidine-Based Bathing on Nosocomial Infections

This study has been completed.
Sponsor:
Collaborators:
Weill Medical College of Cornell University
Washington University School of Medicine
Johns Hopkins University
University of Tennessee
Information provided by:
Hunter Holmes Mcguire Veteran Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT00448942
First received: March 15, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
  Purpose

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.


Condition Intervention
Nosocomial Bacteremia
Nosocomial Fungemia
MRSA Colonization
MRSA Infection
VRE Colonization
VRE Infection
Behavioral: Daily bathing with Chlorhexidine based product

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
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)

Resource links provided by NLM:


Further study details as provided by Hunter Holmes Mcguire Veteran Affairs Medical Center:

Estimated Enrollment: 5300
Study Start Date: November 2004
Study Completion Date: January 2006
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00448942

Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
United States, Missouri
Barnes Jewish Hospital
St. Louis, Missouri, United States, 63110
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Virginia
Hunter Holmes McGuire Veteran Affairs Medical Center
Richmond, Virginia, United States, 23249
Sponsors and Collaborators
Hunter Holmes Mcguire Veteran Affairs Medical Center
Weill Medical College of Cornell University
Washington University School of Medicine
Johns Hopkins University
University of Tennessee
Investigators
Principal Investigator: Edward W Wong, MD Hunter Holmes Mcguire Veteran Affairs Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00448942     History of Changes
Other Study ID Numbers: 01115, UR8/CCU315346-03-1
Study First Received: March 15, 2007
Last Updated: March 15, 2007
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Hunter Holmes Mcguire Veteran Affairs Medical Center:
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]

Additional relevant MeSH terms:
Bacteremia
Fungemia
Cross Infection
Staphylococcal Infections
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Mycoses
Gram-Positive Bacterial Infections
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on August 20, 2014