Clinical Trial: Duragen Versus Duraguard in Chiari Surgery

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary: 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.
Sponsor: University of Illinois at Chicago

Current Primary Outcome: Physical Health Quality of Life [ Time Frame: 7 years ]

Physical health quality of life (based on SF-36 results) (SF-36 includes 8 scores scaled 0-100; lower score indicating more disability)


Original Primary Outcome: Length of hospital stay; Duration of surgery; Rate of postoperative infections; Rate of postoperative CSF leaks; Rate of other complications; Patients' level of functioning and well being (based on SF-36 results) [ Time Frame: 7 years ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Illinois at Chicago

Dates:
Date Received: August 25, 2008
Date Started: April 2003
Date Completion:
Last Updated: July 8, 2015
Last Verified: July 2015