Duragen Versus Duraguard in Chiari Surgery

Phase 3

Completed

• Conditions: Chiari Malformation
• Interventions: Procedure: Duragen duraplasty; Procedure: Duraguard duraplasty

• Registration Number: NCT00741858
• Lead Sponsor: University of Illinois at Chicago

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 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 Timeline

• Study Start: 2003-04
• Study First Submitted: 2008-08-25
• Study First Submitted QC: 2008-08-25
• Study First Posted: 2008-08-26
• Primary Completion: 2009-12
• Study Completion: 2010-04
• Results First Submitted: 2015-06-15
• Status Verified: 2015-07
• Results First Submitted QC: 2015-07-08
• Last Update Submitted: 2015-07-08
• Results First Posted: 2015-07-13
• Last Update Posted: 2015-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Symptomatic Chiari malformation

Exclusion Criteria

• Presence of ventriculoperitoneal shunt
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DuraGen (sutureless)	Duragen duraplasty	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.
DuraGuard (suturable)	Duraguard duraplasty	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.

Primary Outcome Measures

Name	Time	Method
Physical Health Quality of Life	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)

Trial Locations

Locations (1)

University of Illinois Medical Center in Chicago; 🇺🇸 Chicago, Illinois, United States