Daily Chlorhexidine Bathing and Infection Rates in Critically-ill Patients

Vanderbilt University

Status and phase: Completed; Phase 4

Conditions: Healthcare Associated Infections

Treatments: Other: Non-chlorhexidine bathing; Other: Chlorhexidine bathing

Study type: Interventional

Funder types: Other

Identifiers

NCT02033187

120502

Details and patient eligibility

About

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).

Enrollment: 12,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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12,000 participants in 2 patient groups

Chlorhexidine bathing

Experimental group

Description:

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.

Treatment:

Other: Chlorhexidine bathing

Non-chlorhexidine bathing

Active Comparator group

Description:

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.

Treatment:

Other: Non-chlorhexidine bathing