Journal Article

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

Alemán-Sánchez, Carolina María, Bea-Muñoz, Manuel, Moraleda Pérez, Susana, Martínez-Zapata, Ma José, Esteban Fuertes, Manuel, Bonfill, Xavier, Rigau, David, Jáuregui-Abrisqueta, María Luisa, Barrera Chacón, Juana María, Borau Duran, Albert, Salvador de la Barrera, Sebastián, Espinosa Quirós, Juan Ramón, Ledesma Romano, Luís, Araya, Ignacio

2013

Overview

Background 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. Discussion 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. Trial registration NCT01803919

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V
• Subject: Adolescent / Adult / Aged / Aged, 80 and over / Alloys - administration & dosage / Alloys - chemistry / Anti-Bacterial Agents - administration & dosage / Anti-Bacterial Agents - chemistry / Bacterial Infections - economics / Bacterial Infections - epidemiology / Bacterial Infections - prevention & control / Catheter-Related Infections - economics / Catheter-Related Infections - epidemiology / Catheter-Related Infections - prevention & control / Catheterization / Catheters / Coated Materials, Biocompatible - administration & dosage / Coated Materials, Biocompatible - chemistry / Comorbidity / Cost-Benefit Analysis / Equipment Design / Equipment Failure Analysis / Female / Humans / Incidence / Internal Medicine / Male / Medical research / Medicine / Medicine & Public Health / Medicine, Experimental / Methods / Middle Aged / Prevention / Research Design / Risk Factors / Silver - administration & dosage / Silver - chemistry / Single-Blind Method / Spain - epidemiology / Spinal cord injuries / Spinal Cord Injuries - economics / Spinal Cord Injuries - epidemiology / Spinal Cord Injuries - therapy / Study Protocol / Treatment Outcome / Urinary catheterization / Urinary Catheters - economics / Urinary Catheters - statistics & numerical data / Urinary Incontinence - economics / Urinary Incontinence - epidemiology / Urinary Incontinence - therapy / Urinary tract infections / Urology / Young Adult