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A prospective observational clinical study on the infection rate of antibiotic impregnated catheter and conventional catheter in the treatment of extraventricular drainage

A prospective observational clinical study on the infection rate of antibiotic impregnated catheter and conventional catheter in the treatment of extraventricular drainage

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100053269
Enrollment
Unknown
Registered
2021-11-18
Start date
2021-12-01
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extra ventricular drainage

Interventions

Normal EVD catheter group:No
B-EVD catheter group:No

Sponsors

West China Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-70 years. 2. The subject with conventional EVD catheters or B-EVD catheters implanted due to craniocerebral disease, and is expected to receive EVD draining for at least 72 hours. 3. When EVD catheter was implanted, the subcutaneous distance of drainage tube was more than or equal to 3 cm, and the external drainage system was nursing according to closed system, i.e. burette only opened to drainage bag as needed.

Exclusion criteria

Exclusion criteria: 1. The subject has enrolled or participated in antibiotics, or medical device implantation, and operations that directly affect the cerebrospinal fluid and/or spinal cord device trial within preceding 30 days. 2. The subject has a suspected or documented allergy to the materials of the EVD system, including silicone, rifampin and clindamycin. 3. The subject has a positive CSF culture prior to EVD implant. 4. The subject is immunocompromised. 5. The subject requires more than one ventricular catheter concurrently. 6. The subject has had an EVD catheter within the previous 30 days. 7. The subject has sepsis, ventriculitis, meningitis, a skin infection/inflammation at or near the implantation site, and ear infection on either side, or a severe respiratory tract infection that, in the opinion of the investigator, would most likely compromise the effectiveness of the EVD system. 8. The subject is known to have received systemic antibiotic therapy within a 14 day period preceding screening for inclusion in this study, excluding preoperative prophylactic antibiotic therapy within 48 hours prior to EVD catheter implantation. 9. The subject has an uncontrolled coagulopathy or any other know bleeding diathesis. 10. Irrigation therapy using the EVD system. 11. The subject with cerebrospinal fluid leakage. 12. The subject suffers from medical diseases that other researchers consider unsuitable to participate in this research project.

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative intracranial infection;Incidence of EVD drainage wound infection;Incidence of intracranial infection and wound infection caused by extraventricular drainage;

Countries

China

Contacts

Public ContactZan Xin

West China Hospital of Sichuan University

xzn@foxmail.com+86 13882281390

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026