N/A
N=433
A Registry for Comparing Catheter-Related Infection Rates Among Various Shunt Systems in the Treatment of Hydrocephalus
Hydrocephalus
Bottom Line
View on ClinicalTrials.gov: NCT00280904 ↗Enrolled (actual)
433
Serious AEs
0.0%
Results posted
Mar 2013
Primary outcome: Primary: Number of Subjects With Shunt Infections — 14 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Shunt catheter (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Codman & Shurtleff
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Shunt Infections |
14 | — |
| SECONDARY Non-infectious Antibiotic Impregnated (AI) and Standard Catheter Subjects With Shunt Failures |
40 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00280904). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.