Chiari Study Looking at Use of Duragen Versus Duraguard
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.
Chiari Malformation Type I
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Duragen vs. Duraguard in Chiari Surgery|
- 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 ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2002|
|Estimated Study Completion Date:||December 2008|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00565435
|United States, Illinois|
|Department of Neurosurgery, Univ of Illinois at Chicago|
|Chicago, Illinois, United States, 60612|
|Principal Investigator:||Konstantin Slavin, MD||Department of Neurosurgery , Univeristy of Illinois at Chicago|