Chiari Study Looking at Use of Duragen Versus Duraguard
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ClinicalTrials.gov Identifier: NCT00565435
Verified November 2008 by University of Illinois at Chicago. Recruitment status was: Enrolling by invitation
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.
Condition or disease
Chiari Malformation Type I
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.
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 ]
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Subjects diagnosed with symptomatic Chiari I Malformation
Age >18 years
Clinical Diagnosis of Chiari Type I Malformation
Radiogrpahic evidence of downward tonsillar herniation (displacement of the lower part of the cerebellum below the level of the skull)
Signed Written Informed Consent
Presence of Hydrocephalus or previous CSF diversion procedure, such as shunt
Prior operation on the posterior cranial fossa
Inability to understand the informed consent or unwillingness to participate in the study
Inability to return for follow-up evaluation 3 months after the surgery
Evidence of spinal dysraphism
Allergy or history of allergic reaction to Duragen, Duraguard, or their components