Status:
COMPLETED
A Registry for Comparing Catheter-Related Infection Rates Among Various Shunt Systems in the Treatment of Hydrocephalus
Lead Sponsor:
Codman & Shurtleff
Conditions:
Hydrocephalus
Eligibility:
All Genders
Brief 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.
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
433 Patients enrolled
Trial Details
Trial ID
NCT00280904
Start Date
January 1 2006
End Date
April 1 2008
Last Update
March 8 2013
Active Locations (8)
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1
Children's memorial Hospital
Chicago, Illinois, United States, 60614
2
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
3
British Columbia Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
4
Prince of Wales Hospital
Beijing, China