Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Daily Chlorhexidine Bathing and Infection Rates in Critically-ill Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02033187
Recruitment Status : Completed
First Posted : January 10, 2014
Last Update Posted : January 10, 2014
Sponsor:
Information provided by (Responsible Party):
Michael Noto, 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).


Condition or disease Intervention/treatment Phase
Healthcare Associated Infections Other: Chlorhexidine bathing Other: Non-chlorhexidine bathing Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12000 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
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 Start Date : July 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013


Arm Intervention/treatment
Experimental: 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.
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.

Active Comparator: 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.
Other: 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.




Primary Outcome Measures :
  1. A composite of healthcare-associated infections [ Time Frame: 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 :
  1. Rates of each individual site infection included in the composite calculation above [ Time Frame: 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

  2. Skin reactions [ Time Frame: As needed ]
    Skin reactions related to topical chlorhexidine

  3. Hospital mortality [ Time Frame: One year ]
    Hospital mortality

  4. Hospital length of stay [ Time Frame: One year ]
    Hospital length of stay

  5. ICU length of stay [ Time Frame: One year ]
    ICU length of stay

  6. Rate of cultures positive for multi-drug resistant organisms [ Time Frame: Daily ]
  7. Rates of blood culture contamination [ Time Frame: Daily ]
  8. Rates of healthcare-acquired bloodstream infections [ Time Frame: Daily ]

Other Outcome Measures:
  1. Subgroup analysis by the individual intensive care unit [ Time Frame: One year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02033187


Locations
Layout table for location information
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Layout table for investigator information
Principal Investigator: Michael J Noto, MD, PhD Vanderbilt University Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Michael Noto, Clinical Fellow, Division of Allergy, Pulmonary, and Critical Care Medicine, Vanderbilt University
ClinicalTrials.gov Identifier: NCT02033187     History of Changes
Other Study ID Numbers: 120502
First Posted: January 10, 2014    Key Record Dates
Last Update Posted: January 10, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Cross Infection
Disease Attributes
Pathologic Processes
Iatrogenic Disease
Chlorhexidine
Chlorhexidine gluconate
Pharmaceutical Solutions
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents