Recipient organisationAlder Hey Children's NHS Foundation Trust
Funding£2.2M
PeriodDec 2012 — Feb 2019
In plain English
AI plain-English summary
Every year, thousands of children and adults with hydrocephalus undergo surgery to implant a shunt—a plastic tube that drains excess fluid from the brain—and up to one in ten of those shunts become infected, requiring emergency removal and prolonged antibiotic treatment. This trial directly compares two types of infection-resistant shunts against standard ones. One shunt is impregnated with antibiotics; the other with silver. The question is whether either reduces the rate of infection enough to justify their higher cost. Current evidence is weak, and no large-scale trial has settled the issue. If the trial shows that one of these shunts significantly lowers infection rates, the NHS could adopt it as standard practice, sparing patients repeat surgeries, reducing hospital stays, and cutting antibiotic use. The health economic analysis will tell funders whether the extra upfront cost is offset by savings from fewer infections and revisions. This is an applied clinical trial with immediate practical implications for surgical practice and procurement policy. Success would mean a simple, low-risk change to a routinely used medical device that could prevent serious complications for thousands of patients each year.
View original technical description
Design: Three-arm, multi-centre phase III randomised controlled trial. This will be an open trial. The colour of the shunts differs so surgeons cannot be blinded. The patient will be blinded to VPS type and this will not be recorded in the case notes. Setting: In-patients being treated in Regional Neurosurgery Units in the UK and Ireland. Target population: Children and adults with newly diagnosed hydrocephalus requiring a VPS (Exclusions: previous VPS, active cerebrospinal / peritoneal infection, complex hydrocephalus, ventriulo-atrial or pleural shunts) Health technologies being assessed: a) Bactiseal® antibiotic-impregnated VPS versus standard VPS (comparator) b) Silverline® silver-impregnated VPS versus standard VPS (comparator) c) Secondary comparison of Bactiseal versus Silverline VPS Measurement of costs and outcomes: Primary outcome: Time to first VPS infection Secondary outcomes: • Time to shunt failure of any cause • Reason for shunt failure (infection, mechanical, patient, other) • Types of bacterial VPS infection (organism, antibiotic resistance) • Time to VPS failure following first clean revision • Incremental cost per VPS failure • Incremental cost per QALY gained Health economic analysis: Health economic analysis will adopt the perspective of the NHS. Costs will include those of the catheters, duration of intensive care stay and hospital admission, antibiotic treatment, and contact with health professionals. Resource use will be based on entries made in CRFs; complemented with HES data. The approach will follow the procedures of the HTA-funded CATCH trial (standard operating procedure currently being drafted), and has the benefit of tracking patients according to their NHS number. Given that the economic question under consideration is one of technical efficiency (i.e. which VPS is most cost-effective), we shall approach this as a cost-effectiveness analysis, based on the incremental cost per shunt failure averted. Secondary economic outcomes will include: (i) incremental cost per shunt infection avoided; and (ii) incremental cost per QALY gained. Stratified cost-effectiveness analyses will be conducted on important, pre-specified patient subgroups (including neonates, patients under 1 year old, patients with a previous EVD).
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