Daily Chlorhexidine Bathing and Infection Rates in Critically-ill Patients

Phase 4

Completed

• Conditions: Healthcare Associated Infections
• Interventions: Other: Non-chlorhexidine bathing; Other: Chlorhexidine bathing

• Registration Number: NCT02033187
• Lead Sponsor: Vanderbilt University

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2014-01
• Study First Submitted: 2014-01-08
• Study First Submitted QC: 2014-01-09
• Last Update Submitted: 2014-01-09
• Study First Posted: 2014-01-10
• Last Update Posted: 2014-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12000

Inclusion Criteria

• All patients admitted to the medical, surgical, trauma, cardiovascular and neuro adult intensive care units at Vanderbilt University Medical Center

Exclusion Criteria

1. 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.
2. Patients with known allergy to chlorhexidine gluconate
3. Age < 18 years old
4. Patients where daily bathing would not be safe

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Non-chlorhexidine bathing	Non-chlorhexidine bathing	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.
Chlorhexidine bathing	Chlorhexidine bathing	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.

Primary Outcome Measures

Name	Time	Method
A composite of healthcare-associated infections	Daily	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

Secondary Outcome Measures

Name	Time	Method
Rates of each individual site infection included in the composite calculation above	Daily	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
Skin reactions	As needed	Skin reactions related to topical chlorhexidine
Hospital mortality	One year	Hospital mortality
Hospital length of stay	One year	Hospital length of stay
ICU length of stay	One year	ICU length of stay
Rate of cultures positive for multi-drug resistant organisms	Daily
Rates of blood culture contamination	Daily
Rates of healthcare-acquired bloodstream infections	Daily

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States