title: Clinical impact and cost-effectiveness of split-septum and single-use prefilled flushing device vs 3-way stopcock on central line-associated bloodstream infection rates in India: a randomized clinical trial conducted by the International Nosocomial Infection Control Consortium (INICC).
abstract: BACKGROUND
  Three-way stopcocks (3WSCs) are open systems used on intravenous tubing. Split septums (SSs) are closed systems with prepierced septums. Single-use prefilled flushing devices (SUFs) carry a lower risk of contamination than standard intravenous flushing. 3WSC and standard flushing are widely used in developing countries. This is the first randomized clinical trial (RCT) to compare rates of central line-associated bloodstream infection (CLABSI) between patients using an SS + SUF and those using a 3WSC.
  
  
  METHODS
  An RCT with 1096 patients in 5 adult intensive care units was conducted between April 2012 and August 2014 to evaluate their impact on CLABSI rates. Centers for Disease Control and Prevention/National Healthcare Safety Network definitions were applied and International Nosocomial Infection Control Consortium methodology were followed.
  
  
  RESULTS
  The study cohort included 547 patients and 3619 central line (CL)-days for the SS + SUF group, and 549 patients and 4061 CL-days for the 3WSC group. CLABSI rates were 2.21 per 1000 CL-days for SS + SUF and 6.40 per 1000 CL-days for 3WSC (relative risk, 0.35; 95% confidence interval [CI], 0.16-0.76; P = .006). The SS + SUF group had significantly better cumulative infection-free catheter survival compared with the 3WSC group (hazard ration, 0.33; 95% CI, 0.15-0.73; P = .006). Using an SS + SUF represents savings of $402.88 and an increase in quality-adjusted life years of 0.0008 per patient. For each extra dollar invested in an SS + SUF, $124 was saved.
  
  
  CONCLUSIONS
  The use of SS + SUF is cost-effective and associated with a significantly lower CLABSI rate compared with the use of 3WSC.
authors.affiliation: International Nosocomial Infection Control Consortium, Buenos Aires, Argentina. Electronic address: victor_rosenthal@inicc.org.
authors.forename: Victor Daniel
authors.initials: VD
authors.lastname: Rosenthal
authors.affiliation: Breach Candy Hospital Trust, Mumbai, India.
authors.forename: Farokh Earch
authors.initials: FE
authors.lastname: Udwadia
authors.affiliation: Kovai Medical Center and Hospital, Coimbatore, India.
authors.forename: Siva
authors.initials: S
authors.lastname: Kumar
authors.affiliation: Breach Candy Hospital Trust, Mumbai, India.
authors.forename: Aruna
authors.initials: A
authors.lastname: Poojary
authors.affiliation: Kovai Medical Center and Hospital, Coimbatore, India.
authors.forename: Rathi
authors.initials: R
authors.lastname: Sankar
authors.affiliation: International Nosocomial Infection Control Consortium, Buenos Aires, Argentina; Universidad Tecnológica Nacional, Facultad Regional San Nicolás and Consejo Nacional de Investigaciones Científicas y Técnicas, San Nicolás, Argentina.
authors.forename: Pablo Wenceslao
authors.initials: PW
authors.lastname: Orellano
authors.affiliation: Breach Candy Hospital Trust, Mumbai, India.
authors.forename: Shilpa
authors.initials: S
authors.lastname: Durgad
authors.affiliation: Kovai Medical Center and Hospital, Coimbatore, India.
authors.forename: Mahendran
authors.initials: M
authors.lastname: Thulasiraman
authors.affiliation: Breach Candy Hospital Trust, Mumbai, India.
authors.forename: Shweta
authors.initials: S
authors.lastname: Bahirune
authors.affiliation: Breach Candy Hospital Trust, Mumbai, India.
authors.forename: Shubhangi
authors.initials: S
authors.lastname: Kumbhar
authors.affiliation: Breach Candy Hospital Trust, Mumbai, India.
authors.forename: Priyanka
authors.initials: P
authors.lastname: Patil
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016470:Bacteremia / Q000453:epidemiology* / Q000517:prevention & control*; D055499:Catheter-Related Infections / Q000453:epidemiology* / Q000517:prevention & control; D002405:Catheterization, Central Venous / Q000009:adverse effects* / Q000379:methods*; D057785:Catheters; D003362:Cost-Benefit Analysis; D003428:Cross Infection / Q000453:epidemiology* / Q000517:prevention & control; D005260:Female; D006801:Humans; D007194:India; D008297:Male; D008875:Middle Aged
keywords: Bacteremia; Catheter-related infection; Developing countries; Health care–acquired infection; Hospital infection; Intensive care unit; Randomized clinical trial; Single-use prefilled flushing device; Split septum; Three-way stopcock