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| Tracking Information | |||||
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| First Received Date ICMJE | March 15, 2007 | ||||
| Last Updated Date | March 15, 2007 | ||||
| Start Date ICMJE | November 2004 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Impact of Chlorhexidine-Based Bathing on Nosocomial Infections | ||||
| Official Title ICMJE | 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) | ||||
| 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. |
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| 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. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Defined Population Observational Model: Natural History Time Perspective: Longitudinal Time Perspective: Retrospective |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Daily bathing with Chlorhexidine based product | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 5300 | ||||
| Completion Date | January 2006 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00448942 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 01115, UR8/CCU315346-03-1 | ||||
| Study Sponsor ICMJE | Hunter Holmes Mcguire Veteran Affairs Medical Center | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Hunter Holmes Mcguire Veteran Affairs Medical Center | ||||
| Verification Date | March 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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