title: The British antibiotic and silver-impregnated catheters for ventriculoperitoneal shunts multi-centre randomised controlled trial (the BASICS trial): study protocol.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  International Standard Randomised Controlled Trial Number: ISRCTN49474281.
authors.affiliation: Department of Neurosurgery, The Walton Centre NHS Foundation Trust, Lower Lane, Fazakerley, Liverpool L9 7LJ, UK. michael.jenkinson@liv.ac.uk.
authors.forename: Michael D
authors.initials: MD
authors.lastname: Jenkinson
authors.forename: Carrol
authors.initials: C
authors.lastname: Gamble
authors.forename: John C
authors.initials: JC
authors.lastname: Hartley
authors.forename: Helen
authors.initials: H
authors.lastname: Hickey
authors.forename: Dyfrig
authors.initials: D
authors.lastname: Hughes
authors.forename: Michaela
authors.initials: M
authors.lastname: Blundell
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Griffiths
authors.forename: Tom
authors.initials: T
authors.lastname: Solomon
authors.forename: Conor L
authors.initials: CL
authors.lastname: Mallucci
mesh_terms: D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000191:economics; D055499:Catheter-Related Infections / Q000175:diagnosis / Q000191:economics / Q000382:microbiology / Q000517:prevention & control*; D057785:Catheters / Q000009:adverse effects* / Q000191:economics; D020099:Coated Materials, Biocompatible / Q000191:economics; D017046:Cost Savings; D003362:Cost-Benefit Analysis; D024881:Drug Resistance, Bacterial; D004867:Equipment Design; D004868:Equipment Failure; D017048:Health Care Costs; D006801:Humans; D006849:Hydrocephalus / Q000191:economics / Q000601:surgery*; D012834:Silver / Q000191:economics; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom; D017287:Ventriculoperitoneal Shunt / Q000009:adverse effects* / Q000191:economics / Q000295:instrumentation*
chemical_list: D000900:Anti-Bacterial Agents; D020099:Coated Materials, Biocompatible; D012834:Silver