Bonfill Xavier, Rigau David, Jáuregui-Abrisqueta María Luisa, Barrera Chacón Juana María, de la Barrera Sebastián Salvador, Alemán-Sánchez Carolina María, Bea-Muñoz Manuel, Moraleda Pérez Susana, Borau Duran Albert, Espinosa Quirós Juan Ramón, Ledesma Romano Luís, Fuertes Manuel Esteban, Araya Ignacio, Martínez-Zapata Ma José
BMC Urol. 2013 Jul 30;13:38. doi: 10.1186/1471-2490-13-38.
Patients 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/DESIGN: The 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.
The 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.
NCT01803919.
留置导尿管的非急性脊髓损伤患者发生尿路感染（UTI）的风险增加。抗菌银合金涂层硅胶导尿管似乎是一种有前景的降低UTI的干预措施；然而，实际证据不能外推至脊髓损伤患者。本试验的目的是比较脊髓损伤患者使用抗菌银合金涂层硅胶导尿管与标准导尿管预防UTI的效果。
方法/设计：本研究将采用开放、随机、多中心、平行的临床试验，并进行盲法评估。研究将纳入742例脊髓损伤患者，这些患者需要至少7天的尿道插管作为膀胱排尿的方法。参与者将通过网络进行集中随机分组，并分配到两个研究组之一（银合金涂层或标准导尿管）。导尿管使用最长30天，或在临床医生认为必要时提前拔除。主要结局将是拔除导尿管时或插管后30天（以先发生者为准）UTI的发生率。将进行意向性分析以及对所有患者的初步分析。
本研究的目的是评估银合金涂层硅胶导尿管是否能改善脊髓损伤患者的UTI。ESCALE旨在成为第一项评估银合金涂层导尿管对脊髓损伤患者疗效的研究。
NCT01803919。
