Duragen Versus Duraguard in Chiari Surgery

Last updated: July 8, 2015
Sponsor: University of Illinois at Chicago
Overall Status: Completed

Phase

3

Condition

Holoprosencephaly

Birth Defects

Treatment

N/A

Clinical Study ID

NCT00741858
UIC 2002-0232
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Symptomatic Chiari malformation

Exclusion

Exclusion Criteria:

  • Presence of ventriculoperitoneal shunt

  • Pregnancy

Study Design

Total Participants: 34
Study Start date:
April 01, 2003
Estimated Completion Date:
April 30, 2010

Study 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.

Connect with a study center

  • University of Illinois Medical Center in Chicago

    Chicago, Illinois 60612
    United States

    Site Not Available

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