Daily Chlorhexidine Bathing and Infection Rates in Critically-ill Patients

Study Overview
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Brief Summary
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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).

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

Conditions
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Healthcare Associated Infections

Intervention / Treatment
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* Other: Chlorhexidine bathing
* Other: Non-chlorhexidine bathing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients admitted to the medical, surgical, trauma, cardiovascular and neuro adult intensive care units at Vanderbilt University Medical Center Exclusion Criteria: 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. Patients with known allergy to chlorhexidine gluconate Age < 18 years old Patients where daily bathing would not be safe

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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chlorhexidine bathing<br>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<br>* 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.<br>|
| Active Comparator: Non-chlorhexidine bathing<br>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<br>* 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.<br>|

What is the study measuring?
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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 |