- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00741858
Duragen Versus Duraguard in Chiari Surgery
July 8, 2015 updated by: Konstantin V. Slavin, University of Illinois at Chicago
Prospective Randomized Study of Duragen vs. 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
34
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Illinois
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Chicago, Illinois, United States, 60612
- University of Illinois Medical Center in Chicago
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Symptomatic Chiari malformation
Exclusion Criteria:
- Presence of ventriculoperitoneal shunt
- Pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
Posterior cranial fossa repair and enlargement with application of dural patch (Duragen)
Other Names:
|
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.
|
Posterior cranial fossa repair and enlargement with application of dural patch (Duraguard)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
7 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Konstantin V Slavin, MD, University of Illinois at Chicago
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2003
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
April 1, 2010
Study Registration Dates
First Submitted
August 25, 2008
First Submitted That Met QC Criteria
August 25, 2008
First Posted (Estimate)
August 26, 2008
Study Record Updates
Last Update Posted (Estimate)
July 13, 2015
Last Update Submitted That Met QC Criteria
July 8, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Nervous System Malformations
- Neural Tube Defects
- Congenital Abnormalities
- Arnold-Chiari Malformation
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Estrogens
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptive Agents, Female
- Estradiol
- Estradiol 17 beta-cypionate
- Estradiol 3-benzoate
- Polyestradiol phosphate
Other Study ID Numbers
- UIC 2002-0232
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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