Open Access Study protocol

The British antibiotic and silver-impregnated catheters for ventriculoperitoneal shunts multi-centre randomised controlled trial (the BASICS trial): study protocol

Michael D Jenkinson12*, Carrol Gamble3, John C Hartley4, Helen Hickey3, Dyfrig Hughes5, Michaela Blundell3, Michael J Griffiths28, Tom Solomon27 and Conor L Mallucci26

Author Affiliations

1 Department of Neurosurgery, The Walton Centre NHS Foundation Trust, Lower Lane, Fazakerley, Liverpool L9 7LJ, UK

2 Institute of Infection and Global Health, University of Liverpool, The Ronald Ross Building, 8 West Derby Street, Liverpool L69 7BE, UK

3 Medicines for Children Research Network (MCRN) Clinical Trials Unit, University of Liverpool Division of Child Health, Institute of Child Health, Royal Liverpool Children’s Hospital, Alder Hey, Liverpool L12 2AP, UK

4 Department of Microbiology, Great Ormond Street Children’s Hospital, Great Ormond Street, London WC1N 3JH, UK

5 Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, Gwynedd LL57 1UT, UK

6 Department of Paediatric Neurosurgery, Alder Hey Children’s Hospital NHS Foundation Trust, Eaton Road, West Derby, Liverpool L12 2AP, UK

7 Department of Neurology, The Walton Centre NHS Foundation Trust, Lower Lane, Fazakerley, Liverpool L9 7LJ, UK

8 Department of Paediatric Neurology, Alder Hey Children’s Hospital NHS Foundation Trust, Eaton Road, Liverpool L12 2AP, UK

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Trials 2014, 15:4  doi:10.1186/1745-6215-15-4

Published: 3 January 2014

Abstract

Background

Insertion 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/design

Overall, 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.

Discussion

The 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 registration

International Standard Randomised Controlled Trial Number: ISRCTN49474281.

Keywords:
Ventriculoperitoneal shunt; Infection; Clinical trial; Antibiotic-impregnated; Silver-impregnated