Clinical Trial: Chiari Study Looking at Use of Duragen Versus Duraguard

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Observational

Official Title: Duragen vs. Duraguard in Chiari Surgery

Brief Summary: Since Chiari malformation is a common disease, many patients require surgical operation to relieve pressure from the back portion of the skull. The purpose of this research is to compare two different materials that are routinely used to repair the opening in the brain covering during the surgery on the back portion of the skull in patients with symptomatic Chiari Malformation. None of the materials used in this study nor any procedures are experimental.

Detailed Summary: Subjects are randomly assigned to receive either Duragen or Duraguard and then followed for a period of three months after surgery for follow-up evaluation as part of their routine care. The research portion of the study involves subjects completing a quality of life questionnaire each month and the research team reviews each subject's chart for any post-surgical complications.
Sponsor: University of Illinois at Chicago

Current Primary Outcome: Length of ICU stay, length of hospital stay, presence of meningitis, CSF leak, Pseudomeningocele, Wound Infection, Re-operation, Symptomatic change, other complications, number of readmissions and number of emergency room visits [ Time Frame: Three months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Illinois at Chicago

Date Received: November 29, 2007
Date Started: May 2002
Date Completion: December 2008
Last Updated: November 13, 2008
Last Verified: November 2008