A Registry for Comparing Catheter-Related Infection Rates Among Various Shunt Systems in the Treatment of Hydrocephalus

Hydrocephalus Clinical Trial

Official title:

A Registry for Comparing Catheter-Related Infection Rates Among Various Shunt Systems in the Treatment of Hydrocephalus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00280904
• Other study ID #: CRI-IN04-001
• Status: Completed
• Phase: Phase 4
• First received: January 20, 2006
• Last updated: February 5, 2013
• Start date: January 2006
• Est. completion date: April 2008

Study information

• Verified date: February 2013
• Source: Codman & Shurtleff
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Ethics Review Committee
• Study type: Observational

Clinical Trial Summary

The purpose of this Registry is to compare shunt/catheter-related infection rates among various shunt systems when used according to hospital standard of care to treat hydrocephalus.

Description:

Clinical trials show that the majority of infections in shunt systems originate from bacterial contamination introduced at the time of surgery and most appear by 3-4 weeks post-operatively. Protection must persist well beyond the surgical procedure to make certain that all contaminating bacteria are completely eradicated.

Depending upon the institution, shunt infection rates have been known to be as little as 1% to as much as 25%. However, two prospective trials that have been published from large databases, with a consistent definition of infection, have indicated an overall infection rate of approximately 10%

This prospective non-randomized, open-label Registry is designed to investigate and identify short-term shunt/catheter-related infection rates in ventriculoperitoneal shunt systems using various catheters during hospital standard of care treatment of Subjects with hydrocephalus. Prospective Subjects will include those receiving shunts for the first time (de novo) and those with previously implanted shunts for whom catheter or total system replacements are required.

This Registry will enroll 450 implanted Subjects of any age who meet all the inclusion criteria and none of the exclusion criteria and who provide signed Informed Consent to participate in this clinical Registry

Subjects will be followed for up to 90 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 433
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• The Subject requires a surgical procedure to implant (de novo) a ventriculoperitoneal shunt or to replace an already implanted shunt catheter for the treatment of hydrocephalus.

• The Subject (family member/legal representative) has completed the Informed Consent process prior to enrollment into this Registry.

• The Subject (family member/legal representative) is willing to comply with the Registry protocol timelines & requirements.

Exclusion Criteria:

• The Subject's planned shunt has distal drainage to the heart.

• The Subject has an active infection of the indwelling shunt system, cerebrospinal fluid or abdominal cavity.

• The Subject has ventriculitis, peritonitis or meningitis.

• The Subject has sepsis.

• The Subject has a history of poor wound healing.

• The Subject has symptoms pertaining to: a skin infection at or near the site of any incisions; an ear infection on either side; a respiratory tract infection; or a urinary tract infection that, in the Investigator's opinion is clinically significant and might compromise the outcome of this Registry.

• The Subject has had any form of bowel surgery 30 days prior to device implant or anticipates bowel surgery within 90 days following device implant

• The Subject has loculation(s) within the ventricular system.

• The Subject is otherwise determined by the Investigator to be medically unsuitable for participation in this Registry.

• The Subject is currently enrolled in another drug or device trial or has been previously entered in this trial.

• The Subject exhibits other difficulties, which would preclude follow-up for 90 days.

• The Subject is a prisoner.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Catheter-Related Infections
• Hydrocephalus

Intervention

Device:
• Shunt catheter
standard of care implantation of shunt (any brand). Subjects are followed for 90 days to obtain information about whether or not an infection occurred.

Locations

Country	Name	City	State
Canada	British Columbia Children's Hospital	Vancouver	British Columbia
China	Prince of Wales Hospital	Beijing
China	Ua Shan Hospital	Shanghai
Hong Kong	Queen Mary Hospital	Hong Kong
India	All India Insitute of Medical Sciences	New Delhi
Singapore	National Neuroscience Institute	Singapore
United States	Children's memorial Hospital	Chicago	Illinois
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Codman & Shurtleff

Countries where clinical trial is conducted

United States,  Canada,  China,  Hong Kong,  India,  Singapore, 

References & Publications (1)

Steinbok P, Milner R, Agrawal D, Farace E, Leung GK, Ng I, Tomita T, Wang E, Wang N, Wong GK, Zhou LF. A multicenter multinational registry for assessing ventriculoperitoneal shunt infections for hydrocephalus. Neurosurgery. 2010 Nov;67(5):1303-10. doi: 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With Shunt Infections	Number of shunt infections occurring in subjects implanted with antibiotic impregnated catheters and standard catheters.	Implantation to Explant	No
Secondary	Non-infectious Antibiotic Impregnated (AI) and Standard Catheter Subjects With Shunt Failures		April 2008	No