Bactiseal Catheter Safety Registry Study

Recruiting

• Conditions: Hydrocephalus
• Interventions: Device: antibiotic-impregnated catheter

• Registration Number: NCT06276543
• Lead Sponsor: Integra LifeSciences Corporation

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-08
• Study First Submitted QC: 2024-02-21
• Study First Posted: 2024-02-26
• Study Start: 2024-09-29
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-27
• Primary Completion: 2026-07-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
antibiotic-impregnated catheter group	antibiotic-impregnated catheter	Hydrocephalus patients implanted with antibiotic-impregnated catheter.

Primary Outcome Measures

Name	Time	Method
Infection outcome	2 years post catheter implanted.	Incidence of Bactiseal Shunt catheter related infection within 2 years post implant.
Safety outcome	2 years post catheter implanted.	Incidence of adverse events of a subject within 2 years post implant Bactiseal

Trial Locations

Locations (8)

Zhujiang Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China

the 2nd Affiliated Hospital of Harbin Medical University; 🇨🇳 Harbin, Heilongjiang, China

the Zhongnan Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China

West China Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China

Xuanwu Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Beijing Hospital; 🇨🇳 Beijing, Beijing, China

Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China

Shanghai Children's Medical Center affiliated to Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China