Duragen Versus Duraguard in Chiari Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Randomized Study of Duragen vs. Duraguard in Chiari Surgery

Conditions
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Chiari Malformation

Intervention / Treatment
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* Procedure: Duragen duraplasty
* Procedure: Duraguard duraplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic Chiari malformation Exclusion Criteria: Presence of ventriculoperitoneal shunt Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DuraGen (sutureless)<br>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. | Procedure: Duragen duraplasty<br>* Posterior cranial fossa repair and enlargement with application of dural patch (Duragen)<br>* Other names: Duragen (Arm 1; active comparator);|
| Active Comparator: DuraGuard (suturable)<br>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. | Procedure: Duraguard duraplasty<br>* Posterior cranial fossa repair and enlargement with application of dural patch (Duraguard)<br>* Other names: Duraguard (Arm 2; active comparator);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chiari malformation;, Duraplasty;, Posterior fossa decompression;, Duragen;, Duraguard