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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
12,000
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.
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.
Vanderbilt University Medical Center
Nashville, Tennessee, United States
A composite of healthcare-associated infections
A composite of the following healthcare-associated infections: 1. Central line-associated blood stream infections (CLABSI) 2. Possible or probable ventilator associated pneumonia (VAP) 3. Catheter-associated urinary tract infection (CAUTI) 4. C. difficile-associated diarrhea
Time frame: Daily
Rates of each individual site infection included in the composite calculation above
1. Central line-associated blood stream infections (CLABSI) 2. Possible or probable ventilator associated pneumonia (VAP) 3. Catheter-associated urinary tract infection (CAUTI) 4. C. difficile-associated diarrhea
Time frame: Daily
Skin reactions
Skin reactions related to topical chlorhexidine
Time frame: As needed
Hospital mortality
Hospital mortality
Time frame: One year
Hospital length of stay
Hospital length of stay
Time frame: One year
ICU length of stay
ICU length of stay
Time frame: One year
Rate of cultures positive for multi-drug resistant organisms
Time frame: Daily
Rates of blood culture contamination
Time frame: Daily
Rates of healthcare-acquired bloodstream infections
Time frame: Daily
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