Duragen Versus Duraguard in Chiari Surgery

NCT ID: NCT00741858

Last Updated: 2015-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-04-30
• Study Completion Date: 2010-04-30

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.

Conditions

Chiari Malformation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DuraGen (sutureless)

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.

Group Type: EXPERIMENTAL

Duragen duraplasty

Intervention Type: PROCEDURE

Posterior cranial fossa repair and enlargement with application of dural patch (Duragen)

DuraGuard (suturable)

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.

Group Type: ACTIVE_COMPARATOR

Duraguard duraplasty

Intervention Type: PROCEDURE

Posterior cranial fossa repair and enlargement with application of dural patch (Duraguard)

Interventions

Duragen duraplasty

Posterior cranial fossa repair and enlargement with application of dural patch (Duragen)

Intervention Type: PROCEDURE

Duraguard duraplasty

Posterior cranial fossa repair and enlargement with application of dural patch (Duraguard)

Intervention Type: PROCEDURE

Other Intervention Names

Duragen (Arm 1; active comparator); Duraguard (Arm 2; active comparator)

Eligibility Criteria

Inclusion Criteria

• Symptomatic Chiari malformation

Exclusion Criteria

• Presence of ventriculoperitoneal shunt
• Pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Konstantin V. Slavin

Professor Neurologic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Konstantin V Slavin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

University of Illinois Medical Center in Chicago

Chicago, Illinois, United States

Countries

United States

Related Links

http://chicago.medicine.uic.edu/departments___programs/departments/neurosurgery/

Departmental website

Other Identifiers

UIC 2002-0232

Identifier Type: -

Identifier Source: org_study_id

NCT00565435

Identifier Type: -

Identifier Source: nct_alias