Duragen Versus Duraguard in Chiari Surgery

University of Illinois

Status and phase: Completed; Phase 3

Conditions: Chiari Malformation

Treatments: Procedure: Duraguard duraplasty; Procedure: Duragen duraplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT00741858

UIC 2002-0232

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Symptomatic Chiari malformation

Exclusion criteria

• Presence of ventriculoperitoneal shunt
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

DuraGen (sutureless)

Experimental group

Description:

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.

Treatment:

Procedure: Duragen duraplasty

DuraGuard (suturable)

Active Comparator group

Description:

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.

Treatment:

Procedure: Duraguard duraplasty