Duragen Versus Duraguard in Chiari Surgery
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chiari Malformation |
Procedure: Duraplasty with Duragen Procedure: Duraplasty with Duraguard |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Prospective Randomized Study of Duragen vs. Duraguard in Chiari Surgery |
- 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) [ Time Frame: 7 years ] [ Designated as safety issue: Yes ]
| 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 - 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: Duraplasty with Duragen
Posterior cranial fossa repair and enlargement with application of dural patch (Duragen)
Other Name: Duragen (Arm 1; active comparator)
|
|
Active Comparator: DuraGuard (suturable)
Duraguard - 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: Duraplasty with Duraguard
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Symptomatic Chiari malformation
Exclusion Criteria:
- Presence of ventriculoperitoneal shunt
- Pregnancy
Contacts and Locations| United States, Illinois | |
| University of Illinois Medical Center in Chicago | |
| Chicago, Illinois, United States, 60612 | |
| Principal Investigator: | Konstantin V Slavin, MD | University of Illinois |
More Information
Additional Information:
No publications provided
| Responsible Party: | Konstantin Slavin, MD, Department of Neurosurgery, University of Illinois at Chicago |
| ClinicalTrials.gov Identifier: | NCT00741858 History of Changes |
| Other Study ID Numbers: | UIC 2002-0232 |
| Study First Received: | August 25, 2008 |
| Last Updated: | August 17, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Illinois:
|
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 valerate Estradiol 3-benzoate Estradiol 17 beta-cypionate |
Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Contraceptive Agents Reproductive Control Agents Therapeutic Uses Contraceptive Agents, Female |
ClinicalTrials.gov processed this record on May 16, 2013