Daily Chlorhexidine Bathing and Infection Rates in Critically-ill Patients

Phase 4 Study of the Impact of Daily Bathing With Chlorhexidine-gluconate Impregnated Bathing Cloths on Nosocomial Infections in Critically Ill Patients

Healthcare-associated infections are a major cause of morbidity among critically ill patients. Bathing critically ill patients with cloths impregnated with the broad-spectrum antimicrobial agent chlorhexidine-gluconate may decrease healthcare-associated infections. The purpose of this study is to evaluate the effect of daily bathing with disposable chlorhexidine-impregnated bathing cloths, as compared to daily bathing with disposable standard non-chlorhexidine-impregnated bathing cloths, on the rates of healthcare-associated infections in critically-ill patients.

Hypothesis: Daily bathing of the skin with chlorhexidine-impregnated bathing cloths will result in reduced rates of healthcare-associated infections in patients admitted to intensive care units (ICU).

Study Overview

• Status: Completed
• Conditions: Healthcare Associated Infections
• Intervention / Treatment: Other: Chlorhexidine bathing; Other: Non-chlorhexidine bathing

• Study Type: Interventional
• Enrollment (Actual): 12000
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

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, surgical, trauma, cardiovascular and neuro adult intensive care units at Vanderbilt University Medical Center

Exclusion Criteria:

1. Being cared for in the burn ICU or patients with TEN/SJS or burns being cared for in one of the non-burn intensive care units.
2. Patients with known allergy to chlorhexidine gluconate
3. Age < 18 years old
4. Patients where daily bathing would not be safe

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chlorhexidine bathing; Patients in an ICU randomized to treatment arm 1 will be bathed with single use, no rinse, disposable cloths impregnated with 2% chlorhexidine gluconate solution (Sage® 2% Chlorhexidine Gluconate Cloths). Bathing of the skin of the arms, chest, abdomen, back, both legs, perineum, and buttocks will be performed daily and as needed after patients become soiled. The face and neck will not be bathed in this manner but will be bathed with water-moistened washcloths. All other infection control and cleaning procedures will be performed per the current practice in each intensive care unit.	Other: Chlorhexidine bathing; Patients in an ICU randomized to treatment arm 1 will be bathed with single use, no rinse, disposable cloths impregnated with 2% chlorhexidine gluconate solution (Sage® 2% Chlorhexidine Gluconate Cloths). Bathing of the skin of the arms, chest, abdomen, back, both legs, perineum, and buttocks will be performed daily and as needed after patients become soiled. The face and neck will not be bathed in this manner but will be bathed with water-moistened washcloths. All other infection control and cleaning procedures will be performed per the current practice in each intensive care unit.
Active Comparator: Non-chlorhexidine bathing; Patients in an ICU randomized to treatment arm 2 will be bathed with single use, no rinse, disposable cloths that do not contain chlorhexidine gluconate solution (Sage Comfort Bath® Cleansing Washcloths). Bathing of the skin of the arms, chest, abdomen, back, both legs, perineum, and buttocks will be performed daily and as needed after patients become soiled. The face and neck will not be bathed in this manner but will be bathed with water-moistened washcloths. All other infection control and cleaning procedures will be performed per the current protocols in each intensive care unit.	Other: Non-chlorhexidine bathing; Patients in an ICU randomized to treatment arm 2 will be bathed with single use, no rinse, disposable cloths that do not contain chlorhexidine gluconate solution (Sage Comfort Bath® Cleansing Washcloths). Bathing of the skin of the arms, chest, abdomen, back, both legs, perineum, and buttocks will be performed daily and as needed after patients become soiled. The face and neck will not be bathed in this manner but will be bathed with water-moistened washcloths. All other infection control and cleaning procedures will be performed per the current protocols in each intensive care unit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A composite of healthcare-associated infections	A composite of the following healthcare-associated infections: Central line-associated blood stream infections (CLABSI); Possible or probable ventilator associated pneumonia (VAP); Catheter-associated urinary tract infection (CAUTI); C. difficile-associated diarrhea	Daily

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of each individual site infection included in the composite calculation above	Central line-associated blood stream infections (CLABSI); Possible or probable ventilator associated pneumonia (VAP); Catheter-associated urinary tract infection (CAUTI); C. difficile-associated diarrhea	Daily
Skin reactions	Skin reactions related to topical chlorhexidine	As needed
Hospital mortality	Hospital mortality	One year
Hospital length of stay	Hospital length of stay	One year
ICU length of stay	ICU length of stay	One year
Rate of cultures positive for multi-drug resistant organisms		Daily
Rates of blood culture contamination		Daily
Rates of healthcare-acquired bloodstream infections		Daily

Other Outcome Measures

Outcome Measure	Time Frame
Subgroup analysis by the individual intensive care unit	One year

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Investigators: Principal Investigator: Michael J Noto, MD, PhD, Vanderbilt University Medical Center

Publications and helpful links

General Publications

• Noto MJ, Domenico HJ, Byrne DW, Talbot T, Rice TW, Bernard GR, Wheeler AP. Chlorhexidine bathing and health care-associated infections: a randomized clinical trial. JAMA. 2015 Jan 27;313(4):369-78. doi: 10.1001/jama.2014.18400.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: January 8, 2014
• First Submitted That Met QC Criteria: January 9, 2014
• First Posted (Estimate): January 10, 2014

Study Record Updates

• Last Update Posted (Estimate): January 10, 2014
• Last Update Submitted That Met QC Criteria: January 9, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Iatrogenic Disease; Infections; Communicable Diseases; Cross Infection; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Chlorhexidine
• Other Study ID Numbers: 120502