Clinical trial NCT06276543: Bactiseal Catheter Safety Registry Study
Official title: A Multi-center, Retrospective Registry Study on the Safety of Bactiseal Catheter
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hydrocephalus
Keywords: hydrocephalus
cerebrospinal fluid
Shunt
antibiotic-impregnated catheter
infection
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
First posted: 2024-02-26
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 200 hydrocephalus patients will be enrolled and adverse events will be collected for those enrolled subjects within two years after the implantation of the Bactiseal catheter from January 01, 2019 to June 30, 2022, through reviewing subject record or hospital database.

Brief 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)


Eligibility criteria: Inclusion Criteria:

1. The informed consent is exempted by the Ethics Committee of a research center. Or a subject or his/her legal representative signed the informed consent form (ICF) prior to the enrollment.
2. A subject had an indication suitable to use Bactiseal Catheter.
3. A subject implanted hydrocephalus shunt catheter for at least 2 years at the time of enrollment.

Exclusion Criteria:

1. A subject didn't have an indication suitable to use the catheter.
2. A subject was known to be allergic to a component or ingredient of the catheter to be implanted, including silicone catheter, rifampicin, and clindamycin.
3. According to the comprehensive judgment of an investigator, a subject had an infection of the implant site when the shunt is implanted, such as ventriculitis, meningitis, peritonitis, and local implant skin infection.
4. A subject was simultaneously implanted with another shunt catheter different from Bactiseal Catheter.
5. A subject had a contraindication of the shunt operation.
6. A subject had uncorrected coagulopathy or any bleeding disorder.

Primary outcomes:
measure: Infection outcome
timeFrame: 2 years post catheter implanted.
measure: Safety outcome
timeFrame: 2 years post catheter implanted.
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
city: Harbin
country: China
facility: the 2nd Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Wuhan
country: China
facility: Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: the Zhongnan Hospital of Wuhan University
state: Hubei
city: Shanghai
country: China
facility: Shanghai Children's Medical Center affiliated to Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
affiliation: Shanghai Children's Medical Center Affiliated to Shanghai Jiaotong University School of Medicine
name: Nan Bao, MD
role: PRINCIPAL_INVESTIGATOR
References: