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Chiari Study Looking at Use of Duragen Versus Duraguard

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
University of Illinois
ClinicalTrials.gov Identifier:
NCT00565435
First received: November 29, 2007
Last updated: November 13, 2008
Last verified: November 2008
History of Changes
  Purpose

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
Chiari Malformation Type I

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Duragen vs. Duraguard in Chiari Surgery

Further study details as provided by University of Illinois:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: May 2002
Estimated Study Completion Date: December 2008
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00565435

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

No publications provided

Responsible Party: Konstantin Slavin, MD, Department of Neurosurgery
ClinicalTrials.gov Identifier: NCT00565435     History of Changes
Other Study ID Numbers: 2002-0232
Study First Received: November 29, 2007
Last Updated: November 13, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Illinois:
Chiari I Malformation

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

ClinicalTrials.gov processed this record on May 19, 2013