This prospective, randomized, controlled trial will compare the incidence of nosocomial infections (composite of primary bloodstream infections, catheter-associated urinary tract infections, ventilator-associated pneumonia, and surgical site infections) that occur in intensive care unit (ICU) patients bathed with 2% chlorhexidine solution versus patients who receive standard bathing (soap and water or non-medicated cloths).
Upon study enrollment, patients will be randomized to one of two study arms. Patients in study arm one will receive standard bathing (soap and water or non-medicated cloth) daily. Patients in study arm two will receive a 2% chlorhexidine bath on study day 1 and every 48 hours and a standard bath (soap and water or non-medicated cloths) on study day 2 and every 48 hours. Patients will be followed until ICU day 28 or discharged from the surgical ICU. Hypothesis: Compared to standard daily bathing, chlorhexidine-based bathing on ICU admission and every 48 hours will decrease the incidence of nosocomial infections.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
350
Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours
The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily.
Surgical Intensive Care Unit, The Methodist Hospital
Houston, Texas, United States
Incidence of Nosocomial Infection
Proportion of patients with one or more incident nosocomial infections. Primary Efficacy Endpoints\* (Composite of new nosocomial infection) * Primary Bloodstream Infection * Catheter Related Urinary Tract Infection * Ventilator-Associated Pneumonia\*\* * Surgical Site Infection (\*)Diagnosed using the Centers for Disease Control criteria for hospital acquired infections. Only infections that develop 48 hours or more after study enrollment will be counted as primary endpoints. (\*\*)Ventilator associated pneumonia is defined as pneumonia that developed after 48 hours of mechanical ventilation.
Time frame: Up to 28 days
Incidence of Skin Irritation
The incidence of new onset skin irritation will be recorded and graded for severity using the National Cancer Institute Common Terminology Criteria for Adverse Events v4.03.
Time frame: up to 28 days
ICU Length of Stay in Days
Number of days in the ICU after enrollment in study until first ICU discharge.
Time frame: up to 28 days
Number of Patients With In-hospital Mortality
Time frame: up to 28 days or until first hospital discharge
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