Advice
Clinical and technical evidence
Clinical and technical evidence
A literature search was carried out for this briefing in accordance with the interim process and methods statement. This briefing includes the most relevant or best available published evidence relating to the clinical effectiveness of the technology. Further information about how the evidence for this briefing was selected is available on request by contacting mibs@nice.org.uk.
Published evidence
This briefing summarises 1 non-comparative study including 29 children.
Table 1 summarises the clinical evidence as well as its strengths and limitations.
Overall assessment of the evidence
The evidence on SecurAcath for CSF drainage was limited to 1 prospective study (Frassanito et al. 2016).
In order to improve the evidence base, additional studies including a comparative study of SecurAcath and alternative CSF drainage methods would be useful. This could include data on complication rates related to use of the device as well as catheter-related complications (such as dislocation) for SecurAcath compared with sutures, staples or adhesive securement devices. Studies investigating the use of SecurAcath should be adequately powered to identify differences in the effectiveness outcomes. Ideally, future studies of the device and its comparators would be in the form of randomised controlled trials in the NHS.
Table 1 Summary of the evidence
|
Study size, design and location |
29 children (age 3 weeks to 16 years), prospective study, Italy |
|
Intervention and comparator(s) |
SecurAcath only; used to secure 25 ventricular catheters (1 patient had 2 catheters in the same procedure for bilateral brain abscess) and 5 lumbar drainages. |
|
Key outcomes |
Dwell time ranged from 1 to 4 weeks (median 22 days). No complications related to the use of the device were observed. There were no cases of dislocation, accidental removal, kinking or tearing of the catheter, skin erosion, or infection. |
|
Strengths and limitations |
Small sample size (power calculation was not provided) and there was no randomised comparator in the study. |