Duragen Versus Duraguard in Chiari Surgery
Information source: University of Illinois
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chiari Malformation
Intervention: Duraplasty with Duragen (Procedure); Duraplasty with Duraguard (Procedure)
Phase: N/A
Status: Recruiting
Sponsored by: University of Illinois Official(s) and/or principal investigator(s):
Konstantin V Slavin, MD, Principal Investigator, Affiliation: University of Illinois
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 eash
material, patient's outcomes, length of surgery and the hospital stay, etc.
Clinical Details
Official title: Prospective Randomized Study of Duragen vs. Duraguard in Chiari Surgery
Study design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Length of hospital stay; Duration of surgery; Rate of postoperative infections; Rate of postoperative CSF leaks; Rate of other complications; Patients' level of functioning and well being (based on SF-36 results)
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Symptomatic Chiari malformation
Exclusion Criteria:
- Presence of ventriculoperitoneal shunt
- Pregnancy
Locations and Contacts
University of Illinois Medical Center in Chicago, Chicago, Illinois 60612, United States; Recruiting
Konstantin V Slavin, MD, Phone: 312-996-4842, Email: kslavin@uic.edu
Nada Mlinarevich, RN, MPH, Phone: 312-996-4842, Email: nmlina1@uic.edu
Konstantin V Slavin, MD, Principal Investigator
Additional Information
Departmental website
Starting date: April 2003
Ending date: April 2010
Last updated: April 1, 2009
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