Duragen Versus Duraguard in Chiari Surgery
Completed · Phase 3
Conditions studied: Chiari Malformation
In brief
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.
Key facts
- Study ID
- NCT00741858
- Run by
- University of Illinois at Chicago
- People needed
- 34
- Starts
- 2003-04-01
- Expected to finish
- 2010-04-01
- Last updated by the study team
- 2015-07-13
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Symptomatic Chiari malformation
You may not qualify if…
- Presence of ventriculoperitoneal shunt
- Pregnancy
Where it is running
- University of Illinois Medical Center in Chicago — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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