The British antibiotic and silver-impregnated catheters for ventriculoperitoneal shunts multi-centre randomised controlled trial the BASICS trial: study protocolReportar como inadecuado




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Trials

, 15:4

First Online: 03 January 2014Received: 03 October 2013Accepted: 11 December 2013DOI: 10.1186-1745-6215-15-4

Cite this article as: Jenkinson, M.D., Gamble, C., Hartley, J.C. et al. Trials 2014 15: 4. doi:10.1186-1745-6215-15-4

Abstract

BackgroundInsertion of a ventriculoperitoneal shunt VPS for the treatment of hydrocephalus is one of the most common neurosurgical procedures in the UK, but failures caused by infection occur in approximately 8% of primary cases. VPS infection is associated with considerable morbidity and mortality and its management results in substantial cost to the health service. Antibiotic-impregnated rifampicin and clindamycin and silver-impregnated VPS have been developed to reduce infection rates. Whilst there is some evidence showing that such devices may lead to a reduction in VPS infection, there are no randomised controlled trials RCTs to support their routine use.

Methods-designOverall, 1,200 patients will be recruited from 17 regional neurosurgical units in the UK and Ireland. Patients of any age undergoing insertion of their first VPS are eligible. Patients with previous indwelling VPS, active and on-going cerebrospinal fluid CSF or peritoneal infection, multiloculated hydrocephalus requiring multiple VPS or neuroendoscopy, and ventriculoatrial or ventriculopleural shunt planned will be excluded. Patients will be randomised 1:1:1 to either standard silicone comparator, antibiotic-impregnated, or silver-impregnated VPS. The primary outcome measure is time to VPS infection. Secondary outcome measures include time to VPS failure of any cause, reason for VPS failure infection, mechanical failure, or patient failure, types of bacterial VPS infection organism type and antibiotic resistance, and incremental cost per VPS failure averted.

DiscussionThe British antibiotic and silver-impregnated catheters for ventriculoperitoneal shunts multi-centre randomised controlled trial the BASICS trial is the first multi-centre RCT designed to determine whether antibiotic or silver-impregnated VPS reduce early shunt infection compared to standard silicone VPS. The results of this study will be used to inform current neurosurgical practice and may potentially benefit patients undergoing shunt surgery in the future.

Trial registrationInternational Standard Randomised Controlled Trial Number:ISRCTN49474281.

KeywordsVentriculoperitoneal shunt Infection Clinical trial Antibiotic-impregnated Silver-impregnated AbbreviationsBASICS trialBritish antibiotic and silver-impregnated catheters for ventriculoperitoneal shunts multi-centre randomised controlled trial

CATCHCatheter infections in children

CEConformité Européenne

CIConfidence interval

CNSCentral nervous system

CSFCerebrospinal fluid

EVDExternal ventricular drain

HESHospital episode statistics

HRHazard ratio

IQIntelligence quotient

NHSNational Health Service

NICENational Institute for Health and Care Excellence

NIHR-HTANational Institute of Health Research Health Technology Assessment

QALYQuality-adjusted life-year

RCTRandomised controlled trial

RRRelative risk

SBNSSociety of British Neurological Surgeons

ShineSpina bifida, hydrocephalus, information, networking, equality

VPSVentriculoperitoneal shunt.

Electronic supplementary materialThe online version of this article doi:10.1186-1745-6215-15-4 contains supplementary material, which is available to authorized users.

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Autor: Michael D Jenkinson - Carrol Gamble - John C Hartley - Helen Hickey - Dyfrig Hughes - Michaela Blundell - Michael J Grif

Fuente: https://link.springer.com/







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