Chiari Study Looking at Use of Duragen Versus Duraguard

Chiari Malformation Type I Clinical Trial

Official title:

Duragen vs. Duraguard in Chiari Surgery

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00565435
• Other study ID #: 2002-0232
• Status: Enrolling by invitation
• Phase: N/A
• First received: November 29, 2007
• Last updated: November 13, 2008
• Start date: May 2002
• Est. completion date: December 2008

Study information

• Verified date: November 2008
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arnold-Chiari Malformation
• Chiari Malformation Type I
• Congenital Abnormalities

Locations

Country	Name	City	State
United States	Department of Neurosurgery, Univ of Illinois at Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Three months	Yes