title: Clinical efficacy and safety of Securflux®, an anti-reflux device for intravenous infusion.
abstract: OBJECTIVE
  Catheter obstruction or patency inhibition of the venous access cannula is a frequently experienced problem in patients to whom intravenous (IV) solutions are administered. In this study we assessed the efficacy and safety of Securflux® a disposable device with a back-check valve to prevent reflux in IV infusion sets.
  
  
  METHODS
  A total of 177 adult patients requiring IV medication for at least 24 hours duration were randomized into two groups: with and without the use of Securflux®. Assessments were performed the 10 days after catheter insertion, over three daily visits. The incidence of the onset of reflux (visual/non-visual) and the consequences of reflux for both the patient and healthcare staff were assessed.
  
  
  RESULTS
  There were 4577 follow-up (study) visits (53.4% in patients with Securflux® and 46.6% without Securflux®). Venous reflux was observed in 14.2% of all visits, more frequently without Securflux® (21.3% vs. 8.1%; P<.05). Reflux was mostly visual without Securflux® (7.6% vs. 0.7%) and non-visual with Securflux® (13.6% vs. 7.3%). The onset of venous reflux carried more consequences, such as inhibition of the line and patient discomfort, in the infusions without Securflux® (81.1% vs. 73.5% of the visits; P<.05). There were no safety concerns related to Securflux®.
  
  
  CONCLUSIONS
  Securflux® is effective, safe and useful for the prevention of venous reflux onset in patients administered IV medication.
authors.affiliation: Department of Clinical Hematology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain. FBarreras@santpau.cat
authors.forename: Ferran
authors.initials: F
authors.lastname: Barreras
authors.forename: Manuel
authors.initials: M
authors.lastname: Cabeza
authors.forename: Laura
authors.initials: L
authors.lastname: Collantes de Terán
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015331:Cohort Studies; D004867:Equipment Design; D005260:Female; D006083:Graft Occlusion, Vascular / Q000517:prevention & control*; D006801:Humans; D007262:Infusions, Intravenous / Q000295:instrumentation*; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D062666:Vascular Access Devices; D014654:Vascular Patency / Q000502:physiology