The British Antibiotic and Silver Impregnated Catheters for ventriculoperitoneal Shunts multi-centre randomised control trial
| ISRCTN | ISRCTN49474281 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49474281 |
| Protocol serial number | Version 2.0; HTA 10/104/30 |
| Sponsor | Alder Hey Children's Hospital Foundation Trust (UK) |
| Funder | Health Technology Assessment Programme: 10/104/30 |
- Submission date
- 11/12/2012
- Registration date
- 17/12/2012
- Last edited
- 06/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims:
Two new devices have been introduced to try to reduce shunt infection; Bactiseal and Silverline shunts. This study will compare these new shunts to standard shunts. Our goal is to establish which provides most protection against infection and to ensure standardisation of care.
Who can participate?
Children and adults with newly diagnosed hydrocephalus.
What does the study involve?
Patients will be randomly chosen to receive either standard, Bactiseal or Silverline shunts. The patient will have a follow up every three months via the telephone and a questionnaire by post.
What are the possible benefits and risks of participating?
There will be no immediate direct benefit to those taking part. But there should be benefits to future patients requiring this treatment as they will potentially have reduced shunt infection.
The main risk of infection is complications for the patients which can leads to prolonged hospital stay, multiple operations and reduced IQ.
Where is the study run from?
Alder Hey Childrens Hospital NHS Foundation Trust.
When is study starting and how long is it expected to run for?
Recruitment will start in early 2013, for 2 years. Patients will be followed up for a maximum of 2.5 years.
Who is funding the study?
National Institute of Health Research Health Technology Assessment Programme
Who is the main contact?
Mr Tom Kearns
thomas.kearns@liv.ac.uk
Contact information
Scientific
Alder Hey Childrens NHS Foundation Trust
Eaton Road
Liverpool
L12 2AP
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Three-arm multi-centre phase III randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | National three-arm, double blind multi-centre randomised controlled trial comparing Bactiseal (antibiotic-impregnated), Silverline (silver-impregnated) and standard (non-impregnated) VPS in patients with newly diagnosed hydrocephalus undergoing insertion of their first permanent shunt |
| Study acronym | BASICS |
| Study objectives | Shunt failure due to infection has plagued this neurosurgical advance ever since it was developed. The incidence of shunt infection varies markedly in the literature from 3-27% (2-6) and is higher in certain groups, e.g. neonates and children under 1 year old, patients treated with a previous temporary external ventricular drain (EVD). Episodes of shunt infection have a significant impact on patients and the NHS and require prolonged inpatient hospitalisation, additional surgery to remove the infected hardware, placement of a temporary EVD, intravenous and intrathecal antibiotics, and further surgery to place a new shunt once the infection has been treated. Other clinical consequences of infection including epilepsy, reduced IQ and loculation have often been reported but never formally studied in the context of a prospective clinical trial. This trial thus addresses the primary question of which shunt catheter is most effective in reducing shunt infection and also has secondary questions addressing the consequences of infection in a clinical and financial context. More details can be found here: http://www.hta.ac.uk/project/2902.asp |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Newly diagnosed hydrocephalus |
| Intervention | We will randomly allocate patients to a standard non impregnated ventriculoperitoneal shunt (VPS), a Silverline (Silver impregnated) VPS or a Bactiseal (antiobiotic impregnated) VPS on a ratio of 1:1:1. All VPS used for the trial are CE marked medical devices being used for their intended purpose. |
| Intervention type | Device |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
Early infection (within 6 months) following insertion of the first de novo VPS |
| Key secondary outcome measure(s) |
1. The proportion of delayed VPS infections (occurring > 6 months following de novo insertion) |
| Completion date | 01/08/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 1200 |
| Total final enrolment | 1605 |
| Key inclusion criteria | 1. Newly diagnosed hydrocephalus of any aetiology (including idiopathic intracranial hypertension) 2. VPS is the primary treatment option 3. Clear CSF sample at the time of shunt insertion 3.1. Failed primary endosopic third ventriculostomy allowed 3.2. Previous indwelling ventricular access device (e.g. Ommaya or Rickham reservoir or similar) allowed 3.3. Previous indwelling EVD allowed |
| Key exclusion criteria | 1. Previous indwelling VPS 2. Active and on-going CSF or peritoneal infection 3. Multi-loculated hydrocephalus requiring multiple VPS or neuro-endoscopy 4. Ventriculo-atrial or ventriculo-pleural shunt planned 5. Allergy to antibiotics associated with the antibiotic shunt |
| Date of first enrolment | 01/03/2013 |
| Date of final enrolment | 01/08/2013 |
Locations
Countries of recruitment
- United Kingdom
- England
- Ireland
Study participating centre
L12 2AP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 26/10/2019 | 17/09/2019 | Yes | No |
| Results article | results | 01/03/2020 | 03/04/2020 | Yes | No |
| Results article | Post hoc analysis | 01/02/2023 | 06/02/2023 | Yes | No |
| Protocol article | protocol | 03/01/2014 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
06/02/2023: Publication reference added.
03/04/2020: Publication reference added.
17/09/2019: Publication reference and total final enrolment added.
01/03/2019: Internal review.
03/10/2018: No publications found, verifying study status with principal investigator.
