Mode
Text Size
Log in / Sign up
N/A N=433

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

Hydrocephalus

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

Back to search