Trial of 2% Chlorhexidine Bathing on Nosocomial Infections in the Surgical Intensive Care Unit

Not Applicable

Completed

Conditions: Cross Infection
Pneumonia, Ventilator-associated
Catheter-related Infections
Infection Due to Indwelling Urinary Catheter
Surgical Wound Infection

Brief Summary: 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).

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Admission to the surgical intensive care unit at The Methodist Hospital (Houston, TX)
Anticipated surgical intensive care unit length of stay of 48 hours or more

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Standard bathing	Standard bathing	Upon study enrollment, patients will be bathed using standard bathing (non-medicated cloths or soap and water) daily.
Chlorhexidine gluconate bathing	Chlorhexidine gluconate	Upon study enrollment, patients will be bathed with a 2% chlorhexidine gluconate solution on study day 1 and every 48 hours until study completion. The patient will be bathed using standard bathing (non-medicated cloths or soap and water) on study day 2 and every 48 hours after that.

Primary Outcome Measures

Name	Time	Method
Incidence of Nosocomial Infection	Up to 28 days	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.

Secondary Outcome Measures

Name	Time	Method
Number of Patients With In-hospital Mortality	up to 28 days or until first hospital discharge
ICU Length of Stay in Days	up to 28 days	Number of days in the ICU after enrollment in study until first ICU discharge.
Incidence of Skin Irritation	up to 28 days	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.