Duragen Versus Duraguard in Chiari Surgery

Chiari Malformation Clinical Trial

Official title:

Prospective Randomized Study of Duragen vs. Duraguard in Chiari Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00741858
• Other study ID #: UIC 2002-0232
• Status: Completed
• Phase: Phase 3
• First received: August 25, 2008
• Last updated: July 8, 2015
• Start date: April 2003
• Est. completion date: April 2010

Study information

• Verified date: July 2015
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: April 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Symptomatic Chiari malformation

Exclusion Criteria:

• Presence of ventriculoperitoneal shunt

• Pregnancy

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

Intervention

Procedure:
• Duragen duraplasty
Posterior cranial fossa repair and enlargement with application of dural patch (Duragen)
• Duraguard duraplasty
Posterior cranial fossa repair and enlargement with application of dural patch (Duraguard)

Locations

Country	Name	City	State
United States	University of Illinois Medical Center in Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes

External Links

•   Departmental website