Bactiseal Catheter Safety Registry Study

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

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)

Study Overview

• Status: Not yet recruiting
• Conditions: Hydrocephalus
• Intervention / Treatment: Device: antibiotic-impregnated catheter

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Hua Tang, MD; Phone Number: 8108 0086 21-63179772; Email: hua.tang@integralife.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100045
      • Beijing Children's Hospital, Capital Medical University
      • Contact: Hailang Sun, MD; Phone Number: 0086-10-59616408; Email: et2007yy@163.com
    • Beijing, Beijing, China, 100730
      • Beijing Hospital
      • Contact: Cheng Sha, MD; Phone Number: 0086-10-85132266; Email: bjshacheng@163.com
    • Beijing, Beijing, China, 100053
      • Xuanwu Hospital, Capital Medical University
      • Contact: Ning Wang, MD; Phone Number: 010-83198899
  • Guangdong
    • Guangzhou, Guangdong, China, 510623
      • Guangzhou Women and Children Medical Center
      • Contact: Fangcheng Li, MD; Phone Number: 020-81886332
    • Guangzhou, Guangdong, China, 519041
      • Guangdong Province People Hospital
      • Contact: Feng Wang, MD; Phone Number: 0086 20 83827812
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
      • Contact: Ting Lei, MD; Phone Number: 0086 27 83662688
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Shanghai Children's Medical Center affiliated to Shanghai Jiaotong University School of Medicine
      • Contact: Nan Bao, MD; Phone Number: 0086-21-38626161; Email: baonan@scmc.com.cn
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital of Sichuan University
      • Contact: Jianguo Xu, MD; Phone Number: 0086 28 85422114

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
antibiotic-impregnated catheter group; Hydrocephalus patients implanted with antibiotic-impregnated catheter.	Device: antibiotic-impregnated catheter; Hydrocephalus patient implant with antibiotic-impregnated catheter to shunt their cerebrospinal fluid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infection outcome	Incidence of Bactiseal Shunt catheter related infection within 2 years post implant.	2 years post catheter implanted.
Safety outcome	Incidence of adverse events of a subject within 2 years post implant Bactiseal	2 years post catheter implanted.

Collaborators and Investigators

• Sponsor: Integra LifeSciences Corporation
• Investigators: Principal Investigator: Nan Bao, MD, Shanghai Children's Medical Center affiliated to Shanghai Jiaotong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 8, 2024
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Actual): February 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: infection; cerebrospinal fluid; hydrocephalus; Shunt; antibiotic-impregnated catheter
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hydrocephalus; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: C-BSEAL-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: individual participant data (IPD) is not available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No