title: Phase II Trial on Extending the Maintenance Flushing Interval of Implanted Ports.
abstract: Retrospective studies suggest that it may be safe to extend the maintenance flushing interval of implanted ports from once every month, as recommended by the manufacturer, to once every 3 months, but no prospective cohort studies have been done specifically assessing the safety and feasibility of this intervention.
  
  
  
  This was a phase II study in oncologic patients who retained a functional port after completion of systemic chemotherapy. Patients enrolled in the study had their port flushed once every 3 months and were observed until completion of five scheduled flushes (one on enrollment and four additional flushes, one every 3 months) or development of any port-related complication, including infections, thrombosis, and occlusions. The primary end points were frequency of port-related complications and port failure requiring removal.
  
  
  
  A total of 87 patients were enrolled in the study. The median follow-up time was 308 days, accounting for a total of 24,202 catheter-days. There were 10 port-related complications (11.49%; 95% CI, 4.85% to 18.14%). No infection or symptomatic thrombosis occurred. The mean time to port-related complication was 184 days. No patients developed port failure while on protocol, but on subsequent medical record review, four patients developed a complication that required port removal or port revision within 30 days of being removed from the trial (4.6%; 95% CI, 0.4% to 8.8%; 0.17/1,000 catheter-days).
  
  
  
  Extending the maintenance flushes of implanted ports in adult oncologic patients to once every 3 months is safe, effective, and likely to increase patient adherence and satisfaction while decreasing the associated cost.
authors.affiliation: University of Louisville James Graham Brown Cancer Center, Louisville, KY.
authors.forename: Jorge A
authors.initials: JA
authors.lastname: Diaz
authors.affiliation: University of Louisville James Graham Brown Cancer Center, Louisville, KY.
authors.forename: Shesh N
authors.initials: SN
authors.lastname: Rai
authors.affiliation: University of Louisville James Graham Brown Cancer Center, Louisville, KY.
authors.forename: Xiaoyoung
authors.initials: X
authors.lastname: Wu
authors.affiliation: University of Louisville James Graham Brown Cancer Center, Louisville, KY.
authors.forename: Ju-Hsien
authors.initials: JH
authors.lastname: Chao
authors.affiliation: University of Louisville James Graham Brown Cancer Center, Louisville, KY.
authors.forename: Ajoy L
authors.initials: AL
authors.lastname: Dias
authors.affiliation: University of Louisville James Graham Brown Cancer Center, Louisville, KY.
authors.forename: Goetz H
authors.initials: GH
authors.lastname: Kloecker
mesh_terms: D015331:Cohort Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D011446:Prospective Studies; D012189:Retrospective Studies; D013927:Thrombosis / Q000601:surgery*; D062666:Vascular Access Devices / Q000706:statistics & numerical data*