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Chiari Study Looking at Use of Duragen Versus Duraguard

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ClinicalTrials.gov Identifier: NCT00565435
Recruitment Status : Unknown
Verified November 2008 by University of Illinois at Chicago.
Recruitment status was:  Enrolling by invitation
First Posted : November 30, 2007
Last Update Posted : November 14, 2008
Sponsor:
Information provided by:
University of Illinois at Chicago

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.

Condition or disease
Chiari Malformation Type I

Detailed Description:
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.

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Duragen vs. Duraguard in Chiari Surgery
Study Start Date : May 2002
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. 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:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects diagnosed with symptomatic Chiari I Malformation
Criteria

Inclusion Criteria:

  1. Age >18 years
  2. Clinical Diagnosis of Chiari Type I Malformation
  3. Radiogrpahic evidence of downward tonsillar herniation (displacement of the lower part of the cerebellum below the level of the skull)
  4. Signed Written Informed Consent

Exclusion Criteria:

  1. Presence of Hydrocephalus or previous CSF diversion procedure, such as shunt
  2. Prior operation on the posterior cranial fossa
  3. Inability to understand the informed consent or unwillingness to participate in the study
  4. Inability to return for follow-up evaluation 3 months after the surgery
  5. Evidence of spinal dysraphism
  6. Allergy or history of allergic reaction to Duragen, Duraguard, or their components
  7. Pregnancy as documented by a urine or blood test

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00565435


Locations
United States, Illinois
Department of Neurosurgery, Univ of Illinois at Chicago
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
Investigators
Principal Investigator: Konstantin Slavin, MD Department of Neurosurgery , Univeristy of Illinois at Chicago

Responsible Party: Konstantin Slavin, MD, Department of Neurosurgery
ClinicalTrials.gov Identifier: NCT00565435     History of Changes
Other Study ID Numbers: 2002-0232
First Posted: November 30, 2007    Key Record Dates
Last Update Posted: November 14, 2008
Last Verified: November 2008

Keywords provided by University of Illinois at Chicago:
Chiari I Malformation

Additional relevant MeSH terms:
Congenital Abnormalities
Arnold-Chiari Malformation
Neural Tube Defects
Nervous System Malformations
Nervous System Diseases