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Antibiotic and Silver Impregnated Catheters for ventriculoperitoneal Shunts (BASICS): a multi-centre randomised controlled trial

BASICS

Antibiotic and Silver Impregnated Catheters for ventriculoperitoneal Shunts (BASICS): a multi-centre randomised controlled trial
Funding NIHR HTA
Portfolio Clinical Specialties
Interventions Device
Randomised Yes
Status Completed
Start Date 01-Dec-2012

Hydrocephalus (commonly known as “water on the brain”) is a condition that can affect all age groups from babies to the elderly. In hydrocephalus, there is an accumulation of the normal brain fluid within the fluid cavities (ventricles) of the brain. Untreated, hydrocephalus can be life-threatening. The commonest treatment involves an operation to insert a tube into the swollen ventricles to drain off the excess fluid. This is called a ventriculoperitoneal shunt.
In the UK, 3000-3500 shunt operations are performed each year. The main risks of a shunt operation is infection (surgical meningitis) and blockage without infection. Infection results in the need for at least two further surgeries, antibiotic treatment and a prolonged hospital stay (2 weeks minimum). Shunt infections can affect mental abilities and can be life-threatening. Blockages without infection on the other hand usually only need a single operation to replace the blocked part and only a few days in hospital
Two new types of shunt have been introduced to try to reduce shunt infection; antibiotic-impregnated shunts and silver-impregnated shunts. This study was designed to assess whether either of these reduce infection in new shunts compared to standard shunts. This study also included an analysis of the cost and health benefits of the different shunts used.
A total of 1605 children and adults treated in neurosurgical units across the UK and Ireland participated in this study. Consent was provided by all participants in the trial. Each participant had an equal chance of receiving one of the three shunt types.
Shunt infection occurred in 6% of participants receiving standard shunts, 5.9% of participants receiving silver-impregnated shunts and 2.2% of participants receiving antibiotic-impregnated shunts.
This study has demonstrated a major reduction in shunt infections in new shunts when using antibiotic impregnated shunts compared to standard or silver-impregnated shunts. A health economic analysis has indicated that antibiotic-impregnated catheters are cost-saving.

Publications

  • Mallucci, CL., et al. (2019). Antibiotic or silver versus standard ventriculoperitoneal shunts (BASICS): a multicentre, single-blinded, randomised trial and economic evaluation
    1. https://doi.org/10.1016/S0140-6736(19)31603-4
  • Jenkinson, M. D., Gamble, C., Hartley, J. C., Hickey, H., Hughes, D., Blundell, M, Griffiths M. J. Solomon T., Mallucci, C. L. (2013). The British antibiotic and silver-impregnated catheters for ventriculoperitoneal shunts multi-centre randomised controlled trial (the BASICS trial): Study protocol. Trials, 15(1). doi:10.1186/1745-6215-15-4
    1. https://doi.org/10.1186/1745-6215-15-4