A randomized controlled trial to assess the efficacy and cost-effectiveness of urinary catheters with silver alloy coating in spinal cord injured patients: trial protocol

BMC Urology

Study Protocol

Carolina María Alemán-Sánchez¹  Sebastián Salvador de la Barrera²  Ignacio Araya³  Manuel Esteban Fuertes⁴  Manuel Bea-Muñoz⁵  María Luisa Jáuregui-Abrisqueta⁶  Susana Moraleda Pérez⁷  Luís Ledesma Romano⁸  Juan Ramón Espinosa Quirós⁹  Juana María Barrera Chacón^1,10  Albert Borau Duran^1,11  David Rigau^1,12  Ma José Martínez-Zapata^1,13  Xavier Bonfill^1,14 

[1] Complejo Hospitalario Universitario Insular Materno Infantil, PO: 35016, Avenida Marítima del Sur, s/n., Las Palmas de Gran Canaria, Spain;Complexo Hospitalario Universitrio A Coruña, PO: 15006, Avenida As Xubias s/n, A Coruña, Spain;Departamento de Cirugía y Traumatología Maxilofacial, Facultad de Odontología - Universidad de Chile, PO: 8380–492, Calle Sergio Livingstone Pohlhammer 943, Independencia, Santiago de Chile, Chile;Hospital Nacional de Parapléjicos de Toledo, Finca de La Peraleda, s/n, PO: 45071, Toledo, Spain;Hospital Universitario Central de Astúrias, Calle Celestino Villamil, s/n., PO: 33006, Oviedo, Spain;Hospital Universitario Cruces, PO: 48903, Plaza de Cruces s/n, Barakaldo Bizkaia, Spain;Hospital Universitario La Paz, Paseo de la Castellana, 261, PO: 28046, Madrid, Spain;Hospital Universitario Miguel Servet, Calle Isabel la Católica, 1-3, PO: 50009, Zaragoza, Spain;Hospital Universitario Puerta del Mar, Avenida Ana de Viya, 21, PO: 11500, Cádiz, Spain;Hospital Universitario Virgen del Rocío, PO: 41013, Avenida Manuel Siurot s/n, Sevilla, Spain;Hospital de Neurorrehabilitación - Instituto Guttmann, Camí de Can Ruti, s/n, PO: 08916, Badalona, Spain;Iberoamerican Cochrane Centre, PO: 08025, Calle Sant Antoni M. Claret, 167, Barcelona, Spain;Institute of Biomedical Research (IIB Sant Pau), Barcelona, Spain;Iberoamerican Cochrane Centre, PO: 08025, Calle Sant Antoni M. Claret, 167, Barcelona, Spain;Institute of Biomedical Research (IIB Sant Pau), Barcelona, Spain;CIBERESP (CIBER de Epidemiología y Salud Pública), Barcelona, Spain;Service of Clinical Epidemiology, Hospital de la Santa Creu i Sant Pau, PO: 08025, Calle Sant Antoni M. Claret, 167, Barcelona, Spain;Iberoamerican Cochrane Centre, PO: 08025, Calle Sant Antoni M. Claret, 167, Barcelona, Spain;Institute of Biomedical Research (IIB Sant Pau), Barcelona, Spain;CIBERESP (CIBER de Epidemiología y Salud Pública), Barcelona, Spain;Department of Paediatrics, Obstetrics and Gynaecology and Preventive Medicine, Universitat Autònoma de Barcelona, Bellaterra, Spain;

关键词: Spinal cord injuries;    Urinary tract infection;    Urinary catheters;    Protocol;    Randomized clinical trial;   

DOI  :  10.1186/1471-2490-13-38

 received in 2013-06-17, accepted in 2013-07-25,  发布年份 2013

来源: Springer

【 摘 要 】

BackgroundPatients with non-acute spinal cord injury that carry indwelling urinary catheters have an increased risk of urinary tract infection (UTIs). Antiseptic Silver Alloy-Coated Silicone Urinary Catheters seems to be a promising intervention to reduce UTIs; however, actual evidence cannot be extrapolated to spinal cord injured patients. The aim of this trial is to make a comparison between the use of antiseptic silver alloy-coated silicone urinary catheters and the use of standard urinary catheters in spinal cord injured patients to prevent UTIs.Methods/DesignThe study will consist in an open, randomized, multicentre, and parallel clinical trial with blinded assessment. The study will include 742 spinal cord injured patients who require at least seven days of urethral catheterization as a method of bladder voiding. Participants will be online centrally randomized and allocated to one of the two study arms (silver alloy-coated or standard catheters). Catheters will be used for a maximum period of 30 days or removed earlier if the clinician considers it necessary. The main outcome will be the incidence of UTIs by the time of catheter removal or at day 30 after catheterization, the event that occurs first. Intention-to-treat analysis will be performed, as well as a primary analysis of all patients.DiscussionThe aim of this study is to assess whether silver alloy-coated silicone urinary catheters improve ITUs in spinal cord injured patients. ESCALE is intended to be the first study to evaluate the efficacy of the silver alloy-coated catheters in spinal cord injured patients.Trial registrationNCT01803919

【 授权许可】

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© Bonfill et al.; licensee BioMed Central Ltd. 2013. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.