Trial record 3 of 35 for:    Arnold-Chiari Malformation

Duragen Versus Duraguard in Chiari Surgery

This study has been completed.
Sponsor:
Information provided by:
University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT00741858
First received: August 25, 2008
Last updated: August 17, 2010
Last verified: August 2010
  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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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
Criteria

Inclusion Criteria:

  • Symptomatic Chiari malformation

Exclusion Criteria:

  • Presence of ventriculoperitoneal shunt
  • Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
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 at Chicago:
Chiari malformation;
Duraplasty;
Posterior fossa decompression;
Duragen;
Duraguard

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

ClinicalTrials.gov processed this record on October 23, 2014