Chiari Study Looking at Use of Duragen Versus Duraguard - Full Text View

Sponsor:	University of Illinois
Information provided by:	University of Illinois
ClinicalTrials.gov Identifier:	NCT00565435

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

Resource links provided by NLM:

Genetics Home Reference related topics: spina bifida

U.S. FDA Resources

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:

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

Exclusion Criteria:

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
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 February 09, 2012