Evidence map›Paper›PMID 23895463›Full record

Trial reportBMC urology2013

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.

Xavier Bonfill, David Rigau, María Luisa Jáuregui-Abrisqueta, Juana María Barrera Chacón, Sebastián Salvador de la Barrera, Carolina María Alemán-Sánchez, Manuel Bea-Muñoz, Susana Moraleda Pérez, Albert Borau Duran, Juan Ramón Espinosa Quirós and 4 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC urology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01803919 (Multicentric, Controlled, Randomized Clinical Trial to Assess the Efficacy and Cost-effectiveness of Urinary Catheters With Silver Alloy Coating Versus Conventional Catheters in Spinal Cord Injured Patients), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.4field-weighted citation impact, top 32% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01803919 naterminatednot on this map

Multicentric, Controlled, Randomized Clinical Trial to Assess the Efficacy and Cost-effectiveness of Urinary Catheters With Silver Alloy Coating Versus Conventional Catheters in Spinal Cord Injured Patients

TypeinterventionalSponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauRan2012 to 2016Enrolled489ConditionsUrinary Tract InfectionArmsSilver Alloy-Coated Urinary Catheters, Conventional Urinary Catheter
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 10 citations in OpenAlex.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 13 institutions in 2 countries.

Xavier Bonfill
David Rigau
María Luisa Jáuregui-Abrisqueta
Juana María Barrera Chacón
Sebastián Salvador de la Barrera
Carolina María Alemán-Sánchez
Manuel Bea-Muñoz
Susana Moraleda Pérez
Albert Borau Duran
Juan Ramón Espinosa Quirós
Luís Ledesma Romano
Manuel Esteban Fuertes
Ignacio Araya
Ma José Martínez-Zapata
Institut d'Investigacions Biomèdiques de Barcelona · ESComplexo Hospitalario Universitario A Coruña · ESHospital de Cruces · ESHospital Nacional de Parapléjicos · ESHospital Universitario Central de Asturias · ESHospital Universitario Insular de Gran Canaria · ESHospital Universitario La Paz · ESHospital Universitario Miguel Servet · ESHospital Universitario Puerta del Mar · ESHospital Universitario Virgen del Rocío · ESIberoamerican Cochrane Centre · ESInstitut Guttmann · ESUniversity of Chile · CL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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. 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 registrationNCT01803919.

Indexed as

AdolescentAdultAgedAged, 80 and overAlloysAnti-Bacterial AgentsBacterial InfectionsCatheter-Related InfectionsCoated Materials, BiocompatibleComorbidityCost-Benefit AnalysisEquipment DesignEquipment Failure AnalysisFemaleHumansIncidenceAlloysAnti-Bacterial AgentsCoated Materials, BiocompatibleSilver

Identifiers

PMID23895463
PMCPMC3735409
OpenAlexW2101029763

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.