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Duragen Versus Duraguard in Chiari Surgery

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ClinicalTrials.gov Identifier: NCT00741858
Recruitment Status : Completed
First Posted : August 26, 2008
Results First Posted : July 13, 2015
Last Update Posted : July 13, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Chiari Malformation Procedure: Duragen duraplasty Procedure: Duraguard duraplasty Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Study of Duragen vs. Duraguard in Chiari Surgery
Study Start Date : April 2003
Primary Completion Date : December 2009
Study Completion Date : April 2010


Arms and Interventions

Arm Intervention/treatment
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)


Outcome Measures

Primary Outcome Measures :
  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)


Eligibility Criteria

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Symptomatic Chiari malformation

Exclusion Criteria:

  • Presence of ventriculoperitoneal shunt
  • Pregnancy
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00741858


Locations
United States, Illinois
University of Illinois Medical Center in Chicago
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
Investigators
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
ClinicalTrials.gov Identifier: NCT00741858     History of Changes
Other Study ID Numbers: UIC 2002-0232
First Posted: August 26, 2008    Key Record Dates
Results First Posted: July 13, 2015
Last Update Posted: July 13, 2015
Last Verified: July 2015

Keywords provided by Konstantin V. Slavin, University of Illinois at Chicago:
Chiari malformation;
Duraplasty;
Posterior fossa decompression;
Duragen;
Duraguard

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