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Duragen Versus Duraguard in Chiari Surgery

This study has been completed.
Information provided by (Responsible Party):
Konstantin V. Slavin, University of Illinois at Chicago Identifier:
First received: August 25, 2008
Last updated: July 8, 2015
Last verified: July 2015
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.

Condition Intervention Phase
Chiari Malformation
Procedure: Duragen duraplasty
Procedure: Duraguard duraplasty
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Study of Duragen vs. Duraguard in Chiari Surgery

Resource links provided by NLM:

Further study details as provided by University of Illinois at Chicago:

Primary Outcome Measures:
  • 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)

Enrollment: 34
Study Start Date: April 2003
Study Completion Date: April 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Procedure: Duragen duraplasty
Posterior cranial fossa repair and enlargement with application of dural patch (Duragen)
Other Name: Duragen (Arm 1; active comparator)
Active Comparator: 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.
Procedure: Duraguard duraplasty
Posterior cranial fossa repair and enlargement with application of dural patch (Duraguard)
Other Name: Duraguard (Arm 2; active comparator)

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.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Symptomatic Chiari malformation

Exclusion Criteria:

  • Presence of ventriculoperitoneal shunt
  • Pregnancy
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Please refer to this study by its identifier: NCT00741858

United States, Illinois
University of Illinois Medical Center in Chicago
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
Principal Investigator: Konstantin V Slavin, MD University of Illinois at Chicago
  More Information

Additional Information:
Responsible Party: Konstantin V. Slavin, Professor Neurologic Surgery, University of Illinois at Chicago Identifier: NCT00741858     History of Changes
Other Study ID Numbers: UIC 2002-0232
Study First Received: August 25, 2008
Results First Received: June 15, 2015
Last Updated: July 8, 2015

Keywords provided by University of Illinois at Chicago:
Chiari malformation;
Posterior fossa decompression;

Additional relevant MeSH terms:
Arnold-Chiari Malformation
Congenital Abnormalities
Neural Tube Defects
Nervous System Malformations
Nervous System Diseases
Polyestradiol phosphate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female processed this record on May 25, 2017