Bactiseal Catheter Safety Registry Study - Trial NCT06276543

Timeline & Enrollment

Primary Outcome

Infection outcome,Safety outcome

Summary

Research Purpose:
 
 This study aims to continuously evaluate the safety of subjects implanted with a catheter
 (trade name: Bactiseal) produced by Integra LifeSciences Production Corporation. Device
 safety will be assessed based on all the adverse events that occurred within 2 years after
 implanted the catheter.
 
 Research Design:
 
 This study is designed to be single arm, multi-center, and retrospective. A total of 200
 subjects will be retrospectively enrolled. Information will be collected on adverse events,
 including bacterial culture and drug resistance testing when infection (if done), of subjects
 enrolled within 2 years after the implantation of the Bactiseal Catheter between January 01,
 2019 and June 30, 2022.
 
 The following information will be collected from subjects' medical records or hospitals'
 databases (if any):
 
 1. General condition of the subjects (including previous shunting and external drainage
 operation)
 
 2. Intraoperative condition and catheter implantation
 
 3. Information on the shunt catheters
 
 4. Adverse events of subjects within 2 years after the operation and classification of the
 adverse events (except anticipated adverse events listed in section 8.1.2)
 
 5. Relevant examinations in case of postoperative infection, including bacterial culture
 and drug resistance testing (if done)

ICD-10 Classifications