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. PATIENTS AND OBJECTIVES: 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.
RCT Entities:
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. PATIENTS AND OBJECTIVES: 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: Peter McCulloch; Douglas G Altman; W Bruce Campbell; David R Flum; Paul Glasziou; John C Marshall; Jon Nicholl; Jeffrey K Aronson; Jeffrey S Barkun; Jane M Blazeby; Isabell C Boutron; W Bruce Campbell; Pierre-Alain Clavien; Jonathan A Cook; Patrick L Ergina; Liane S Feldman; David R Flum; Guy J Maddern; Jon Nicholl; Bournaby C Reeves; Christoph M Seiler; Steven M Strasberg; Jonathan L Meakins; Deborah Ashby; Nick Black; John Bunker; Martin Burton; Marion Campbell; Kalipso Chalkidou; Iain Chalmers; Marc de Leval; Jon Deeks; Patrick L Ergina; Adrian Grant; Muir Gray; Roger Greenhalgh; Milos Jenicek; Sean Kehoe; Richard Lilford; Peter Littlejohns; Yoon Loke; Rajan Madhock; Kim McPherson; Jonathan Meakins; Peter Rothwell; Bill Summerskill; David Taggart; Parris Tekkis; Matthew Thompson; Tom Treasure; Ulrich Trohler; Jan Vandenbroucke Journal: Lancet Date: 2009-09-26 Impact factor: 79.321
Authors: Mary H Wilde; Judith Brasch; Kathryn Getliffe; Kathleen A Brown; James M McMahon; Joyce A Smith; Elizabeth Anson; Wan Tang; Xin Tu Journal: J Wound Ostomy Continence Nurs Date: 2010 May-Jun Impact factor: 1.741
Authors: Jürgen Pannek; Karel Everaert; Sandra Möhr; Will Vance; Frank Van der Aa; Jürg Kesselring Journal: BMC Urol Date: 2020-07-08 Impact factor: 2.264