Efficacy and safety of urinary catheters with silver alloy coating in spinal cord injured patients: a multicentric pragmatic randomized controlled trial. the ESCALE trial

Publication date: Available online 31 May 2017
Source:The Spine Journal
Author(s): Xavier Bonfill, David Rigau, Manuel E. Fuertes, Juana M. Barrera-Chacón, María L. Jáuregui-Abrisqueta, Sebastian Salvador, Carolina M. Alemán-Sánchez, Albert Borau, Manuel Bea-Muñoz, Begoña Hidalgo, Maria J. Andrade, Juan R Espinosa, María José Martínez-Zapata
BackgroundPatients with spinal cord injury (SCI) that carry indwelling urinary catheters have an increased risk of urinary tract infection (UTIs). Antiseptic Silver Alloy-Coated silicone (SAC) urinary catheters prove to be a promising intervention to reduce UTIs; however, current evidence cannot be extrapolated to spinal cord injured patients.PurposeAssess the efficacy of SAC urinary catheters for preventing catheter-associated urinary tract infections (CA-UTI).Design/SettingOpen-label, multicenter (developed in Spain, Portugal, Chile, Turkey and Italy), randomized clinical trial conducted in 14 hospitals from November 2012 to December 2015.Patient SampleEligible patients were male or female with traumatic or medical SCI, aged ≥18 years, requiring an indwelling urinary catheter for at least 7 days.Outcome MeasurementsThe primary outcome was incidence of symptomatic UTIs. Secondary outcome included bacteremia in the urinary tract and adverse events.MethodsPatients were randomized to receive an SAC urinary catheter (experimental group) or a standard catheter (control group) for at least 7 days. Data was compared using Chi-squared test, and also calculating the absolute risk difference (DR) with a 95% confidence Interval (95%CI). An adjusted analysis including different risk factors of UTI was performed. This study was mainly funded by La Marató de TV3" Foundation (grant number # 112210) and the ECRIN Organization. The funders had no role in the interpretation or reporting of results.Results489 patients were included in the study; aged 55 years in the experimental group, and aged 57 in the control group (p=0.870); 72% were men; 43% were hospitalized patients, and 57% were outpatients (p=1). The most frequent cause of SCI was traumatic (73.75%), and the localization was mainly the cervical spine (42.74%). Most of them had an A score on ASIA scale (62.37%). The median time of urethral catheterization was 27 days in the experimental group and 28 days in the control group (p = 0.202). Eighteen (7.41%) patients of the experimental group, and nineteen (7.72%) of the control group had a symptomatic UTI (OR 0.96 (0.49, 1.87)). The adjusted analysis revealed no change in the results. Only three patients experimented bacteremia within the urinary tract. The experimental group presented more adverse events related to the use of the catheter than the control group (OR 0.03 (0.00, 0.06)).ConclusionsThe results of this study do not support the routine use of indwelling antiseptic silver alloy-coated silicone in spinal cord injured patients. However, UTIs associated to long-term urinary catheter use remains a challenge and further investigations are still needed.



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