Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2024-09-29
2026-12-31
Brief Summary
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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)
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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antibiotic-impregnated catheter group
Hydrocephalus patients implanted with antibiotic-impregnated catheter.
antibiotic-impregnated catheter
Hydrocephalus patient implant with antibiotic-impregnated catheter to shunt their cerebrospinal fluid.
Interventions
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antibiotic-impregnated catheter
Hydrocephalus patient implant with antibiotic-impregnated catheter to shunt their cerebrospinal fluid.
Eligibility Criteria
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Inclusion Criteria
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
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.
ALL
No
Sponsors
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Integra LifeSciences Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Nan Bao, MD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Children's Medical Center Affiliated to Shanghai Jiaotong University School of Medicine
Locations
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Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Hospital
Beijing, Beijing Municipality, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
the 2nd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
the Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Shanghai Children's Medical Center affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Jingcao Chen, MD
Role: primary
Jianguo Xu, MD
Role: primary
Other Identifiers
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C-BSEAL-002
Identifier Type: -
Identifier Source: org_study_id
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