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Completed

NCT Number: NCT00741858

Duragen Versus Duraguard in Chiari Surgery

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.

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Key information

Conditions

Chiari Malformation Arnold-Chiari Malformation Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Nervous System Diseases Nervous System Malformations Neural Tube Defects

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Illinois Medical Center in Chicago

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Symptomatic Chiari malformation

Exclusion criteria

  • Presence of ventriculoperitoneal shunt
  • Pregnancy

Treatment and study plan

Duragen duraplasty

Procedure

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

Other names: Duragen (Arm 1; active comparator)

Duraguard duraplasty

Procedure

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

Other names: Duraguard (Arm 2; active comparator)

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Official study title

Prospective Randomized Study of Duragen vs. Duraguard in Chiari Surgery

Important dates

Study start
2003
Primary completion
2009
Study completion
2010
First posted
Aug 26, 2008
Registry last updated
Jul 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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