SIlver-coated lumbar drainage trial

SIlver-coated lumbar drainage trial - SiLuDrain

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00013513

Enrollment

Registered

2017-12-04

Start date

2013-05-04

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

G00 G02

Interventions

Group 1: After information and consent patients have a silver-coated lumbar drain implanted. The implanting physicians fills out the usability questionnaire. Routine blood and CSF samples are obtained

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Indication for lumbar drain

Exclusion criteria

Exclusion criteria: Pregnancy Previous lumbar drain open traumatic brain injury

Design outcomes

Primary

Measure	Time frame
Usability of silver-coated lumbar drains. Non inferiority of silver-coated vs. conventional lumbar drains. Usability is assessed by the implanting physician with a questionnaire in semiquantitative fashion. The primary endpoint is obtained immediately after the lumbar drain is placed.	—

Secondary

Measure	Time frame
Reduction of CSF infections with silver-coated lumbar drains. Clinical signs of infection/meningitis, cSF samples and microbiological analysis of catheter tips are used to determine infection. Time til infection is diagnosed comparing conventional and silver-coated drains. Silver reistence testing: If bacteria are cultivated from CSF or catheter tips, silver solutions are created to asses the growth inhibition of silver solution.	—

Measure

Time frame

Reduction of CSF infections with silver-coated lumbar drains. Clinical signs of infection/meningitis, cSF samples and microbiological analysis of catheter tips are used to determine infection. Time til infection is diagnosed comparing conventional and silver-coated drains. Silver reistence testing: If bacteria are cultivated from CSF or catheter tips, silver solutions are created to asses the growth inhibition of silver solution.

—

Countries

Germany

Contacts

Public ContactMartin Jakobs

Neurochirurgische Klinik, Universitätsklinikum Heidelberg

neurochirurgie.nch@med.uni-heidelberg.de+496221566307

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 24, 2026