Hydrocephalus
Conditions
Keywords
hydrocephalus shunt, infection
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)
Interventions
DEVICEBactiseal Catheter
Bactiseal Catheter manufactured by Codman & Shurtleff, Inc. in the United States is a silicon catheter impregnated in rifampicin and clindamycin.
Sponsors
Integra LifeSciences Corporation
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 50 Participants With Non-infection Within One Year | 1 year | 50 Participants with Non-infection Within One Year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Type and Incidence of Adverse Events of 50 Subjects Within One Year | 1 year | Type and incidence of adverse events of 50 subjects within one year after catheter implanted |
Countries
China
Participant flow
Recruitment details
The study was conducted in Shanghai Children's Medical Center, School of Medicine, Shanghai Jiao Tong University, Beijing Children Hospital, Capital Medical University, Beijing Hospital. The first subject was enrolled in Sep 1, 2020, and last subject was enrolled in Nov 16, 2020.
Pre-assignment details
Screened 62 patients, 50 of them were enrolled, including 7 adult patients and 43 minors (subject age below 18). 12 patients were screening failures for not meeting inclusion/exclusion criteria and without post operation follow up.
Participants by arm
| Arm | Count |
|---|---|
| Bactiseal Catheter Arm Hydrocephalus subjects implanted with a Bactiseal catheter for one year. | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Bactiseal Catheter Arm |
|---|---|
| Age, Categorical <=18 years | 43 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Age, Continuous | 9.38 year |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 50 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment China | 50 participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 50 |
| other Total, other adverse events | 30 / 50 |
| serious Total, serious adverse events | 13 / 50 |
Outcome results
Primary
50 Participants With Non-infection Within One Year
50 Participants with Non-infection Within One Year
Time frame: 1 year
Population: 50 participants implanted Bactiseal Catheter for 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bactiseal Catheter Arm | 50 Participants With Non-infection Within One Year | 1 Participants |
Secondary
Type and Incidence of Adverse Events of 50 Subjects Within One Year
Type and incidence of adverse events of 50 subjects within one year after catheter implanted
Time frame: 1 year