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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Controlled Trial of 2% Chlorhexidine Bathing on Nosocomial Infections in the Surgical Intensive Care Unit

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

Intervention / Treatment
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* Drug: Chlorhexidine gluconate
* Other: Standard bathing


Participation Criteria
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Eligibility Criteria
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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: Pregnancy Age less than 18 years old Braden score of less than 9 upon admission to the surgical intensive care unit Known allergy to chlorhexidine gluconate Active skin irritation upon admission to the surgical intensive care unit

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Chlorhexidine gluconate bathing<br>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. | Drug: Chlorhexidine gluconate<br>* Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours<br>* Other names: Bactoshield 4%;|
| Placebo Comparator: Standard bathing<br>Upon study enrollment, patients will be bathed using standard bathing (non-medicated cloths or soap and water) daily. | Other: Standard bathing<br>* The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 28 days | 
| ICU Length of Stay in Days | Number of days in the ICU after enrollment in study until first ICU discharge. | up to 28 days | 
| Number of Patients With In-hospital Mortality |  | up to 28 days or until first hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nosocomial infection, hospital acquired infection, chlorhexidine, pneumonia, ventilator-associated, catheter-related infections, urinary tract infections, catheter-related, surgical site infection