Duragen Versus Duraguard in Chiari Surgery
Primary Purpose
Chiari Malformation
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Duragen duraplasty
Duraguard duraplasty
Sponsored by
About this trial
This is an interventional treatment trial for Chiari Malformation focused on measuring Chiari malformation;, Duraplasty;, Posterior fossa decompression;, Duragen;, Duraguard
Eligibility Criteria
Inclusion Criteria:
- Symptomatic Chiari malformation
Exclusion Criteria:
- Presence of ventriculoperitoneal shunt
- Pregnancy
Sites / Locations
- University of Illinois Medical Center in Chicago
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DuraGen (sutureless)
DuraGuard (suturable)
Arm Description
Duragen duraplasty - the Duragen patch is applied over the dural defect during Chiari decompression surgery. The Duragen represents sutureless technique of posterior fossa duraplasty. Rest of the treatment is as usual.
Duraguard duraplasty - the Duraguard patch is applied over the dural defect during Chiari decompression surgery and sutured to the dural edge. This represents suturable technique that theoretically provides better (water-tight) dural closure.
Outcomes
Primary Outcome Measures
Physical Health Quality of Life
Physical health quality of life (based on SF-36 results) (SF-36 includes 8 scores scaled 0-100; lower score indicating more disability)
Secondary Outcome Measures
Full Information
NCT ID
NCT00741858
First Posted
August 25, 2008
Last Updated
July 8, 2015
Sponsor
University of Illinois at Chicago
1. Study Identification
Unique Protocol Identification Number
NCT00741858
Brief Title
Duragen Versus Duraguard in Chiari Surgery
Official Title
Prospective Randomized Study of Duragen vs. Duraguard in Chiari Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study evaluates two materials used for duraplasty of the posterior cranial fossa in treatment of Chiari malformation. One material (DuraGen) is a non-suturable collagen matrix that is applied over the defect if brain coverings (dura); the other (DuraGuard) is made out of bovine pericardium and has to be sutured during application. The study compares these two materials used for duraplasty of patients undergoing Chiari surgery in a prospective randomized fashion to check the rate of surgical complications associated with each material, patient's outcomes, length of surgery and the hospital stay, etc.
Detailed Description
The study is aimed at comparative analysis of two frequently used duraplasty materials: one is made out of bovine pericardium, and the other - from bovine collagen derived from bovine achilles tendon. Both materials are routinely used form this intervention (duraplasty), but the question of superiority of one over the other remains open. This study follows patients with Chiari malformation from the time of surgery to the time of their discharge from the hospital and then another 3 months of follow up care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chiari Malformation
Keywords
Chiari malformation;, Duraplasty;, Posterior fossa decompression;, Duragen;, Duraguard
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DuraGen (sutureless)
Arm Type
Experimental
Arm Description
Duragen duraplasty - the Duragen patch is applied over the dural defect during Chiari decompression surgery. The Duragen represents sutureless technique of posterior fossa duraplasty. Rest of the treatment is as usual.
Arm Title
DuraGuard (suturable)
Arm Type
Active Comparator
Arm Description
Duraguard duraplasty - the Duraguard patch is applied over the dural defect during Chiari decompression surgery and sutured to the dural edge. This represents suturable technique that theoretically provides better (water-tight) dural closure.
Intervention Type
Procedure
Intervention Name(s)
Duragen duraplasty
Other Intervention Name(s)
Duragen (Arm 1; active comparator)
Intervention Description
Posterior cranial fossa repair and enlargement with application of dural patch (Duragen)
Intervention Type
Procedure
Intervention Name(s)
Duraguard duraplasty
Other Intervention Name(s)
Duraguard (Arm 2; active comparator)
Intervention Description
Posterior cranial fossa repair and enlargement with application of dural patch (Duraguard)
Primary Outcome Measure Information:
Title
Physical Health Quality of Life
Description
Physical health quality of life (based on SF-36 results) (SF-36 includes 8 scores scaled 0-100; lower score indicating more disability)
Time Frame
7 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Symptomatic Chiari malformation
Exclusion Criteria:
Presence of ventriculoperitoneal shunt
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Konstantin V Slavin, MD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois Medical Center in Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
Links:
URL
http://chicago.medicine.uic.edu/departments___programs/departments/neurosurgery/
Description
Departmental website
Learn more about this trial
Duragen Versus Duraguard in Chiari Surgery
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