Duragen Versus Duraguard in Chiari Surgery
Prospective Randomized Study of Duragen vs. Duraguard in Chiari Surgery
1 other identifier
interventional
34
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2003
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2003
CompletedFirst Submitted
Initial submission to the registry
August 25, 2008
CompletedFirst Posted
Study publicly available on registry
August 26, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedResults Posted
Study results publicly available
July 13, 2015
CompletedJuly 13, 2015
July 1, 2015
6.7 years
August 25, 2008
June 15, 2015
July 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
7 years
Study Arms (2)
DuraGen (sutureless)
EXPERIMENTALDuragen 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 (suturable)
ACTIVE COMPARATORDuraguard 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.
Interventions
Posterior cranial fossa repair and enlargement with application of dural patch (Duragen)
Posterior cranial fossa repair and enlargement with application of dural patch (Duraguard)
Eligibility Criteria
You may qualify if:
- Symptomatic Chiari malformation
You may not qualify if:
- Presence of ventriculoperitoneal shunt
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Illinois Medical Center in Chicago
Chicago, Illinois, 60612, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- k.v. slavin
- Organization
- university of illinois at chicago
Study Officials
- PRINCIPAL INVESTIGATOR
Konstantin V Slavin, MD
University of Illinois at Chicago
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Neurologic Surgery
Study Record Dates
First Submitted
August 25, 2008
First Posted
August 26, 2008
Study Start
April 1, 2003
Primary Completion
December 1, 2009
Study Completion
April 1, 2010
Last Updated
July 13, 2015
Results First Posted
July 13, 2015
Record last verified: 2015-07