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

February 5, 2013 updated by: Codman & Shurtleff
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

433

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • British Columbia Children's Hospital
  • China
      • Beijing, China
        • Prince of Wales Hospital
      • Shanghai, China, 200040
        • Ua Shan Hospital
  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
  • India
      • New Delhi, India, 110029
        • All India Insitute of Medical Sciences
  • Singapore
      • Singapore, Singapore, 308433
        • National Neuroscience Institute
  • United States
    • Illinois
      • Chicago, Illinois, United States, 60614
        • Children's Memorial Hospital
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Milton S. Hershey Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects of any age, gender and ethnicity, with hydrocephalus

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects With Shunt Infections
Time Frame: Implantation to Explant
Number of shunt infections occurring in subjects implanted with antibiotic impregnated catheters and standard catheters.
Implantation to Explant

Secondary Outcome Measures

Outcome Measure
Time Frame
Non-infectious Antibiotic Impregnated (AI) and Standard Catheter Subjects With Shunt Failures
Time Frame: April 2008
April 2008

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Codman & Shurtleff

Investigators

  • Study Chair: Paul Steinbok, MBBS, FRCSC, University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

January 20, 2006

First Submitted That Met QC Criteria

January 20, 2006

First Posted (Estimate)

January 24, 2006

Study Record Updates

Last Update Posted (Estimate)

March 8, 2013

Last Update Submitted That Met QC Criteria

February 5, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRI-IN04-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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