Daily Chlorhexidine Bathing and Infection Rates in Critically-ill Patients

NCT02033187 | Completed Phase 4 DMC

• 1 other identifier: 120502
• Study Type: interventional
• Target: 12,000
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthcare Associated Infections

Outcome Measures

Primary Outcomes (1)

• A composite of healthcare-associated infections

  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

  Daily

Secondary Outcomes (8)

• Rates of each individual site infection included in the composite calculation above

  Daily

• Skin reactions

  As needed

• Hospital mortality

  One year

• Hospital length of stay

  One year

• ICU length of stay

  One year

Other Outcomes (1)

• Subgroup analysis by the individual intensive care unit

  One year

Study Arms (2)

Chlorhexidine bathing

EXPERIMENTAL

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

Non-chlorhexidine bathing

ACTIVE COMPARATOR

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

Interventions

Chlorhexidine bathing OTHER

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.

Chlorhexidine bathing

Non-chlorhexidine bathing OTHER

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.

Non-chlorhexidine bathing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• Noto MJ, Domenico HJ, Byrne DW, Talbot T, Rice TW, Bernard GR, Wheeler AP. Chlorhexidine bathing and health care-associated infections: a randomized clinical trial. JAMA. 2015 Jan 27;313(4):369-78. doi: 10.1001/jama.2014.18400.

  PMID: 25602496 DERIVED

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael J Noto, MD, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Fellow, Division of Allergy, Pulmonary, and Critical Care Medicine

Study Record Dates

• First Submitted: January 8, 2014
• First Posted: January 10, 2014
• Study Start: July 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: January 10, 2014

Record last verified: 2014-01

Locations

US (1)