Hydrocephalus
Conditions
Keywords
Hydrocephalus, Shunt
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 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.
Interventions
DEVICEShunt 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.
Sponsors
Codman & Shurtleff
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Shunt Infections | Implantation to Explant | Number of shunt infections occurring in subjects implanted with antibiotic impregnated catheters and standard catheters. |
Secondary
| Measure | Time frame |
|---|---|
| Non-infectious Antibiotic Impregnated (AI) and Standard Catheter Subjects With Shunt Failures | April 2008 |
Countries
Canada, China, Hong Kong, India, Singapore, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ventriculoperitoneal Shunt Patients Patients receiving a de novo standard or antibiotic (AI) catheter implant or catheter replacement of a prior ventriculoperitoneal shunt. | 433 |
| Total | 433 |
Baseline characteristics
| Characteristic | Ventriculoperitoneal Shunt Patients |
|---|---|
| Age, Categorical <=18 years | 183 Participants |
| Age, Categorical >=65 years | 57 Participants |
| Age, Categorical Between 18 and 65 years | 193 Participants |
| Age Continuous | 31.3 years STANDARD_DEVIATION 25.49 |
| Sex: Female, Male Female | 194 Participants |
| Sex: Female, Male Male | 239 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 433 |
| serious Total, serious adverse events | 0 / 433 |
Outcome results
Primary
Number of Subjects With Shunt Infections
Number of shunt infections occurring in subjects implanted with antibiotic impregnated catheters and standard catheters.
Time frame: Implantation to Explant
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ventriculoperitoneal Shunt Patients | Number of Subjects With Shunt Infections | 14 participants |
Secondary
Non-infectious Antibiotic Impregnated (AI) and Standard Catheter Subjects With Shunt Failures
Time frame: April 2008
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ventriculoperitoneal Shunt Patients | Non-infectious Antibiotic Impregnated (AI) and Standard Catheter Subjects With Shunt Failures | 40 participants |