Clinical Trial: Daily Chlorhexidine Bathing and Infection Rates in Critically-ill Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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).


Detailed Summary:
Sponsor: Vanderbilt University

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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
  • Skin reactions [ Time Frame: As needed ]
    Skin reactions related to topical chlorhexidine
  • Hospital mortality [ Time Frame: One year ]
    Hospital mortality
  • Hospital length of stay [ Time Frame: One year ]
    Hospital length of stay
  • ICU length of stay [ Time Frame: One year ]
    ICU length of stay
  • Rate of cultures positive for multi-drug resistant organisms [ Time Frame: Daily ]
  • Rates of blood culture contamination [ Time Frame: Daily ]
  • Rates of healthcare-acquired bloodstream infections [ Time Frame: Daily ]


Original Secondary Outcome: Same as current

Information By: Vanderbilt University

Dates:
Date Received: January 8, 2014
Date Started: July 2012
Date Completion:
Last Updated: January 9, 2014
Last Verified: January 2014