hydrocephalus
Conditions
Interventions
Observation group:none
Sponsors
Shanghai Children's Medical Center affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who meet all the following inclusion criteria will be enrolled: 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
Exclusion criteria: Subjects who meet any of the following exclusion criterion are excluded: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Bactiseal shunt catheter related infection within 2 years post implant;Incidence of adverse events of a subject within 2 years post implant Bactiseal Shunting catheter; | — |
Countries
China
Contacts
Public ContactBao Nan
Shanghai Children's Medical Center affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed