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:
- Central line-associated blood stream infections (CLABSI)
- Possible or probable ventilator associated pneumonia (VAP)
- Catheter-associated urinary tract infection (CAUTI)
- 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 ]
- 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 [ 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