Duragen Versus Duraguard in Chiari Surgery

Chiari Malformation Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arnold-Chiari Malformation
• Chiari Malformation
• Congenital Abnormalities

• NCT number: NCT00741858
• Study type: Interventional
• Source: University of Illinois at Chicago
• Status: Completed
• Phase: Phase 3
• Start date: April 2003
• Completion date: April 2010