Daily Chlorhexidine Bathing and Infection Rates in Critically-ill Patients

Healthcare Associated Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02033187
• Other study ID #: 120502
• Status: Completed
• Phase: Phase 4
• First received: January 8, 2014
• Last updated: January 9, 2014
• Start date: July 2012
• Est. completion date: July 2013

Study information

• Verified date: January 2014
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12000
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Critical Illness
• Cross Infection
• Healthcare Associated Infections
• Infection

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subgroup analysis by the individual intensive care unit		One year	No
Primary	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	No
Secondary	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	No
Secondary	Skin reactions	Skin reactions related to topical chlorhexidine	As needed	Yes
Secondary	Hospital mortality	Hospital mortality	One year	No
Secondary	Hospital length of stay	Hospital length of stay	One year	No
Secondary	ICU length of stay	ICU length of stay	One year	No
Secondary	Rate of cultures positive for multi-drug resistant organisms		Daily	No
Secondary	Rates of blood culture contamination		Daily	No
Secondary	Rates of healthcare-acquired bloodstream infections		Daily	No