Cost-Effectiveness Study Comparing Chlorhexidine Bathing With Active Surveillance Cultures to Prevent Methicillin-resistant Staphylococcus Aureus & Other Hospital Infections

Cost-Effectiveness of Chlorhexidine Bathing vs. Active Surveillance Cultures to Prevent Acquisition of Methicillin-resistant Staphylococcus Aureus and Other Hospital-Acquired Infections: A Pilot Study

This pilot study in our medical intensive care unit will evaluate the clinical and cost-effectiveness of an active surveillance program for methicillin-resistant Staphylococcus aureus (MRSA), compared to routine daily bathing with chlorhexidine gluconate (CHG)-impregnated cloths. Outcomes include rate of MRSA acquisition, and of other hospital-acquired infections (e.g., catheter-associated bloodstream infections).

Study Overview

• Status: Completed
• Conditions: Staphylococcal Infections
• Intervention / Treatment: Other: Nasal swabs for MRSA culture; Other: Contact isolation; Drug: Chlorhexidine gluconate

• Study Type: Interventional
• Enrollment (Actual): 1518
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Newark, Delaware, United States, 19718
      • Christiana Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All patients admitted to the medical intensive care unit (ICU) are eligible for inclusion

Exclusion Criteria:

• Patient refusal
• Contraindication to nasal swabbing (arm 1)
• Allergy/sensitivity to chlorhexidine gluconate (CHG) (arm 2)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Active surveillance cultures (ASC) (via nasal swabs) will be performed for all patients admitted to the medical intensive care unit (ICU) during the designated study period. All patients will be placed in contact isolation until nasal swabs return negative; otherwise will remain in isolation.	Other: Nasal swabs for MRSA culture; Patients will have nasal swabs performed upon ICU admission, upon discharge, and every 2 weeks while they remain in the ICU.; Other: Contact isolation; All patients will be placed in contact isolation until the results of their active surveillance cultures are negative; if positive, they will remain in isolation.
Active Comparator: 2; Chlorhexidine gluconate (CHG) cloths will be used to bathe patients daily instead of standard soap and water. Active surveillance cultures (ASC) will also be used in this arm, but results will be blinded and not used to determine whether patients should be in contact isolation.	Other: Nasal swabs for MRSA culture; Patients will have nasal swabs performed upon ICU admission, upon discharge, and every 2 weeks while they remain in the ICU.; Drug: Chlorhexidine gluconate; CHG-impregnated cloths (2%) will be used to bathe patients at least daily during the duration of their medical ICU stay. Surveillance cultures will be obtained on admission, discharge and every 2 weeks while in the ICU, but results will be blinded until conclusion of the study.; Other Names: Sage 2% Chlorhexidine gluconate cloth

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acquisition of Methicillin-resistant Staph Aureus (MRSA) Colonization or Infection	Number of patients who acquired MRSA by the time of ICU discharge (based on nasal swab or clinical culture).	During ICU stay

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Central Line Associated Bloodstream Infection	During ICU stay up to six months
Vancomycin Resistant Enterococcal Infection or Colonization	During ICU stay

Collaborators and Investigators

• Sponsor: Christiana Care Health Services
• Collaborators: Sage Products, Inc.
• Investigators: Principal Investigator: Marci Drees, MD, MS, Christiana Care Health Services

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: October 22, 2008
• First Submitted That Met QC Criteria: October 23, 2008
• First Posted (Estimate): October 24, 2008

Study Record Updates

• Last Update Posted (Actual): May 15, 2018
• Last Update Submitted That Met QC Criteria: April 16, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Epidemiology; Staphylococcus aureus; Cross infection; Chlorhexidine; Infection control; Methicillin resistance
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Infections; Communicable Diseases; Staphylococcal Infections; Anti-Infective Agents, Local; Anti-Infective Agents; Dermatologic Agents; Disinfectants; Chlorhexidine; Chlorhexidine gluconate
• Other Study ID Numbers: 28116