Silver-impregnated, antibiotic-impregnated or non-impregnated ventriculoperitoneal shunts to prevent shunt infection: the BASICS three-arm RCT
Insertion of a ventriculoperitoneal shunt to treat hydrocephalus is one of the most common neurosurgical procedures worldwide. Shunt infection affects up to 15% of patients, resulting in long hospital stays, multiple surgeries and reduced cognition and quality of life. The aim of this trial was to d...
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Veröffentlicht in: | Health technology assessment (Winchester, England) England), 2020-03, Vol.24 (17), p.1-114 |
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Zusammenfassung: | Insertion of a ventriculoperitoneal shunt to treat hydrocephalus is one of the most common neurosurgical procedures worldwide. Shunt infection affects up to 15% of patients, resulting in long hospital stays, multiple surgeries and reduced cognition and quality of life.
The aim of this trial was to determine whether or not antibiotic-impregnated ventriculoperitoneal shunts (hereafter referred to as antibiotic shunts) (e.g. impregnated with rifampicin and clindamycin) or silver-impregnated ventriculoperitoneal shunts (hereafter referred to as silver shunts) reduce infection compared with standard ventriculoperitoneal shunts (hereafter referred to as standard shunts).
This was a three-arm, superiority, multicentre, parallel-group randomised controlled trial. Patients and a central primary outcome review panel, but not surgeons or operating staff, were blinded to the type of ventriculoperitoneal shunt inserted.
The trial was set in 21 neurosurgical wards across the UK and the Republic of Ireland.
Participants were patients with hydrocephalus of any aetiology who were undergoing insertion of their first ventriculoperitoneal shunt.
Participants were allocated 1 : 1 : 1 by pressure-sealed envelope to receive a standard non-impregnated, silver-impregnated or antibiotic-impregnated ventriculoperitoneal shunt at the time of insertion. Ventriculoperitoneal shunts are medical devices, and were used in accordance with the manufacturer's instructions for their intended purpose.
The primary outcome was time to ventriculoperitoneal shunt failure due to infection. Secondary outcomes were time to failure for any cause, reason for failure (infection, mechanical), types of ventriculoperitoneal shunt infection, rate of infection after first clean (non-infected) revision and health economics. Outcomes were analysed by intention to treat.
Between 26 June 2013 and 9 October 2017, 1605 patients from neonate to 91 years of age were randomised to the trial:
= 36 to the standard shunt,
= 538 to the antibiotic shunt and
= 531 to the silver shunt. Patients who did not receive a ventriculoperitoneal shunt (
= 4) or who had an infection at the time of insertion (
= 7) were not assessed for the primary outcome. Infection occurred in 6.0% (
= 32/533) of those who received the standard shunt, in 2.2% (
= 12/535) of those who received the antibiotic shunt and in 5.9% (
= 31/526) of those who received the silver shunt. Compared with the standard shunt, antibiotic shunts were associate |
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ISSN: | 1366-5278 2046-4924 |
DOI: | 10.3310/hta24170 |