Clinical trial NCT04496414: Bactiseal Catheter Safety Registry in China
Official title: A Multi-center, Retrospective Registry Study on the Safety of Bactiseal Catheter
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hydrocephalus
Keywords: hydrocephalus shunt
infection
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
First posted: 2020-08-03
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects had an indication suitable to use Bactiseal Catheter and have received a hydrocephalus shunt at least one year ago.

Brief summary: Research Purpose: This study aimed to continue to evaluate safety information from subjects implanted with a catheter (trade name: Bactiseal) produced by Codman \& Shurtleff, Inc. of the United States. Device safety would be assessed based on all the adverse events that occurred within one year after the subjects implanted the catheter.

Detailed description: This study aimed to continue to evaluate safety information from subjects implanted with a catheter (trade name: Bactiseal) produced by Codman \& Shurtleff, Inc. of the United States. Device safety would be assessed based on all the adverse events that occurred within one year after the subjects implanted the catheter.

This study was designed to be single arm, multi-center, and retrospective. A total of 50 patients would be retrospectively enrolled. Information would be collected on adverse events of subjects enrolled within one year after the implantation of the Bactiseal Catheter from August 07, 2018 to Novemver 30, 2020.

The following information would be collected from subjects' medical records or hospitals' databases (if any):

1. General condition of the subjects
2. Intraoperative condition and catheter implantation
3. Information on the shunt product
4. Adverse events of subjects within one year after the operation and classification of the adverse events
5. Relevant examinations in case of postoperative infection
6. Other adverse event-related information (except anticipated adverse events)

Eligibility criteria: Inclusion Criteria:

* The informed consent was exempted by the Ethics Committee of a research center. Either a subject or his/her legal representative signed the informed consent form (ICF) prior to enrollment.
* A subject had an indication suitable to use Bactiseal Catheter.
* A subject received a hydrocephalus shunt at least one year ago.

Exclusion Criteria:

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

Primary outcomes:
measure: 50 Participants With Non-infection Within One Year
timeFrame: 1 year
Secondary outcomes:
measure: Type and Incidence of Adverse Events of 50 Subjects Within One Year
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Children's Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Shanghai
country: China
facility: Shanghai Children's Medical Center affiliated to Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
affiliation: Integra Life Sciences
name: Hua Tang, MD
role: STUDY_DIRECTOR
References: