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Daily Chlorhexidine Bathing and Infection Rates in Critically-ill Patients

Primary Purpose

Healthcare Associated Infections

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Chlorhexidine bathing
Non-chlorhexidine bathing
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Healthcare Associated Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Chlorhexidine bathing

Non-chlorhexidine bathing

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Skin reactions
Skin reactions related to topical chlorhexidine
Hospital mortality
Hospital mortality
Hospital length of stay
Hospital length of stay
ICU length of stay
ICU length of stay
Rate of cultures positive for multi-drug resistant organisms
Rates of blood culture contamination
Rates of healthcare-acquired bloodstream infections

Full Information

First Posted
January 8, 2014
Last Updated
January 9, 2014
Sponsor
Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT02033187
Brief Title
Daily Chlorhexidine Bathing and Infection Rates in Critically-ill Patients
Official Title
Phase 4 Study of the Impact of Daily Bathing With Chlorhexidine-gluconate Impregnated Bathing Cloths on Nosocomial Infections in Critically Ill Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthcare Associated Infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
12000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chlorhexidine bathing
Arm Type
Experimental
Arm 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.
Arm Title
Non-chlorhexidine bathing
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Chlorhexidine bathing
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Non-chlorhexidine bathing
Intervention 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.
Primary Outcome Measure Information:
Title
A composite of healthcare-associated infections
Description
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
Time Frame
Daily
Secondary Outcome Measure Information:
Title
Rates of each individual site infection included in the composite calculation above
Description
Central line-associated blood stream infections (CLABSI) Possible or probable ventilator associated pneumonia (VAP) Catheter-associated urinary tract infection (CAUTI) C. difficile-associated diarrhea
Time Frame
Daily
Title
Skin reactions
Description
Skin reactions related to topical chlorhexidine
Time Frame
As needed
Title
Hospital mortality
Description
Hospital mortality
Time Frame
One year
Title
Hospital length of stay
Description
Hospital length of stay
Time Frame
One year
Title
ICU length of stay
Description
ICU length of stay
Time Frame
One year
Title
Rate of cultures positive for multi-drug resistant organisms
Time Frame
Daily
Title
Rates of blood culture contamination
Time Frame
Daily
Title
Rates of healthcare-acquired bloodstream infections
Time Frame
Daily
Other Pre-specified Outcome Measures:
Title
Subgroup analysis by the individual intensive care unit
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Noto, MD, PhD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25602496
Citation
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.
Results Reference
derived

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Daily Chlorhexidine Bathing and Infection Rates in Critically-ill Patients

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