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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shunt catheter | Device | standard of care implantation of shunt (any brand). Subjects are followed for 90 days to obtain information about whether or not an infection occurred. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Shunt Infections | Number of shunt infections occurring in subjects implanted with antibiotic impregnated catheters and standard catheters. | Implantation to Explant |
| Measure | Description | Time Frame |
|---|---|---|
| Non-infectious Antibiotic Impregnated (AI) and Standard Catheter Subjects With Shunt Failures | April 2008 |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects of any age, gender and ethnicity, with hydrocephalus
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| Name | Affiliation | Role |
|---|---|---|
| Paul Steinbok, MBBS, FRCSC | University of British Columbia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's memorial Hospital | Chicago | Illinois | 60614 | United States | ||
| Penn State Milton S. Hershey Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20871445 | Result | 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: 10.1227/NEU.0b013e3181f07e76. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ventriculoperitoneal Shunt Patients | Patients receiving a de novo standard or antibiotic (AI) catheter implant or catheter replacement of a prior ventriculoperitoneal shunt. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ventriculoperitoneal Shunt Patients | Patients receiving a de novo standard or antibiotic (AI) catheter implant or catheter replacement of a prior ventriculoperitoneal shunt. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Non-infectious Antibiotic Impregnated (AI) and Standard Catheter Subjects With Shunt Failures | Posted | Number | participants | April 2008 |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ventriculoperitoneal Shunt Patients | Patients receiving a de novo standard or antibiotic (AI) catheter implant or catheter replacement of a prior ventriculoperitoneal shunt. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| J. Thomas Megerian | Codman & Shurtleff | 1-508-828-8274 | jmegeri1@its.jnj.com |
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| ID | Term |
|---|---|
| D006849 | Hydrocephalus |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Hershey |
| Pennsylvania |
| 17033 |
| United States |
| British Columbia Children's Hospital | Vancouver | British Columbia | V6H 3V4 | Canada |
| Prince of Wales Hospital | Beijing | China |
| Ua Shan Hospital | Shanghai | 200040 | China |
| Queen Mary Hospital | Hong Kong | Hong Kong |
| All India Insitute of Medical Sciences | New Delhi | 110029 | India |
| National Neuroscience Institute | Singapore | 308433 | Singapore |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
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| Primary | Number of Subjects With Shunt Infections | Number of shunt infections occurring in subjects implanted with antibiotic impregnated catheters and standard catheters. | Posted | Number | participants | Implantation to Explant |
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| 0 |
| 433 |
| 0 |
| 433 |
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