Evaluating the safety of Bactiseal Catheters in hydrocephalus patients

A Multi-center, Retrospective Registry Study on the Safety of Bactiseal Catheter

This study is trying to see if the Bactiseal catheter, used for managing hydrocephalus, is safe and helps prevent infections in patients who had it implanted.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Sex: All
• Sponsor: Integra LifeSciences Corporation (Industry-sponsored)
• Locations: 8 sites (Beijing, Beijing Municipality and 7 other locations)
• Trial ID: NCT06276543 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the safety of the Bactiseal catheter, an antibiotic-impregnated device used for hydrocephalus management. It will retrospectively enroll 200 subjects who had the catheter implanted between January 1, 2019, and June 30, 2022, collecting data on adverse events and infections over a two-year period. Information will be gathered from medical records regarding the subjects' general condition, intraoperative details, and any complications encountered. The study is designed to provide insights into the effectiveness and safety of this catheter in preventing infections.

Who should consider this trial

Good fit: Ideal candidates are patients who have had a Bactiseal catheter implanted for hydrocephalus for at least two years.

Not a fit: Patients who are allergic to components of the Bactiseal catheter or have existing infections at the implant site may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the safety and effectiveness of hydrocephalus treatment by reducing infection rates associated with catheter use.

How similar studies have performed: While this study focuses on a specific catheter, similar studies evaluating antibiotic-impregnated devices have shown promising results in reducing infection rates.

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.

Where this trial is running

Beijing, Beijing Municipality and 7 other locations

• Xuanwu Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Completed)
• Beijing Hospital — Beijing, Beijing Municipality, China (Completed)
• Zhujiang Hospital of Southern Medical University — Guangzhou, Guangdong, China (Completed)
• the 2nd Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China (Recruiting)
• Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Completed)
• the Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China (Recruiting)
• Shanghai Children's Medical Center affiliated to Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)
• West China Hospital of Sichuan University — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Principal investigator: Nan Bao, MD — Shanghai Children's Medical Center Affiliated to Shanghai Jiaotong University School of Medicine
• Study coordinator: Hua Tang, MD

Conditions Hydrocephalus; hydrocephalus; cerebrospinal fluid; Shunt; antibiotic-impregnated catheter; infection