title: [Investigation of the use of triclosan in patients with indwelling catheters: a randomized, double blind, multicenter, placebo-controlled clinical study].
abstract: BACKGROUND
  This article presents the first randomized, double blind, multicenter, placebo-controlled, non-interventional trial with a medical product after approval by the ethical committee of the medical council of North-Rhine. The study investigated the use of the antimicrobial agent triclosan (Farco-fill® Protect) as a liquid for inflation of catheter balloons in patients with chronic indwelling catheters.
  In this study 84 patients were investigated (43 in the treatment group and 41 in the placebo group) all with a suprapubic catheter and a positive history of catheter incrustation. The catheters were changed after 6 weeks and endpoints were the quantitative analysis of the incrustation, weight of the catheter, pain during catheter change and the number of urinary tract infections. The maintenance of the catheter was a secondary endpoint.
  
  
  RESULTS
  The primary endpoint could not be reached because the study, which was initially planned with 70 patients in each arm, had to be terminated due to logistical and technical problems with the catheter weighing. The maintenance of the catheter as the most important clinical parameter showed statistically significant differences with a longer indwelling time in the triclosan group. Adverse events with respect to the product were not recorded.
  
  
  CONCLUSIONS
  Using the antimicrobial solution triclosan as a fluid for inflation of catheter balloons led to a statistically significant extension in the catheter indwelling time. The reduction of pain during changing the catheter and the reduction of incrustation, although not statistically significant, led to an improvement in the quality of life of these patients.
authors.affiliation: Urologische Klinik, Kliniken Maria Hilf GmbH, Viersener Straße 450, 41063, Mönchengladbach, Deutschland, herbert.sperling@mariahilf.de.
authors.forename: H
authors.initials: H
authors.lastname: Sperling
authors.forename: A
authors.initials: A
authors.lastname: Eisenhardt
authors.forename: E
authors.initials: E
authors.lastname: Mumperow
authors.forename: O
authors.initials: O
authors.lastname: Gralla
authors.forename: G
authors.initials: G
authors.lastname: Lümmen
authors.forename: K
authors.initials: K
authors.lastname: Seidali
authors.forename: A
authors.initials: A
authors.lastname: Hinke
authors.forename: T
authors.initials: T
authors.lastname: Jäger
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000891:Anti-Infective Agents, Local / Q000627:therapeutic use; D055499:Catheter-Related Infections / Q000209:etiology* / Q000517:prevention & control*; D002408:Catheters, Indwelling / Q000009:adverse effects*; D004311:Double-Blind Method; D005260:Female; D005858:Germany; D006801:Humans; D008297:Male; D008875:Middle Aged; D015990:Placebo Effect; D016896:Treatment Outcome; D014260:Triclosan / Q000627:therapeutic use*; D062885:Urinary Catheters / Q000009:adverse effects*; D014552:Urinary Tract Infections / Q000209:etiology* / Q000517:prevention & control*
chemical_list: D000891:Anti-Infective Agents, Local; D014260:Triclosan