Duragen Versus Duraguard in Chiari Surgery - Full Text View

Sponsor:	University of Illinois
Information provided by:	University of Illinois
ClinicalTrials.gov Identifier:	NCT00741858

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
Chiari Malformation	Procedure: Duraplasty with Duragen Procedure: Duraplasty with Duraguard

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Prospective Randomized Study of Duragen vs. Duraguard in Chiari Surgery

Resource links provided by NLM:

MedlinePlus related topics: Surgery

Drug Information available for: Estradiol Estradiol 3-benzoate Polyestradiol phosphate Depogen Estradiol dipropionate Estradiol cypionate Estradiol valerate Estradiol acetate

U.S. FDA Resources

Further study details as provided by University of Illinois:

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 ]

Estimated Enrollment:	30
Study Start Date:	April 2003
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Duragen - the Duragen patch is applied over the dural defect during Chiari decompression surgery.	Procedure: Duraplasty with Duragen Posterior cranial fossa repair and enlargement with application of dural patch (Duragen)
2: Experimental Duraguard - the Duraguard patch is applied over the dural defect during Chiari decompression surgery and sutured to the dural edge. Duraguard (Arm 2; active comparator)	Procedure: Duraplasty with Duraguard Posterior cranial fossa repair and enlargement with application of dural patch

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00741858

Locations

United States, Illinois
University of Illinois Medical Center in Chicago	Recruiting
Chicago, Illinois, United States, 60612
Contact: Konstantin V Slavin, MD 312-996-4842 kslavin@uic.edu
Contact: Nada Mlinarevich, RN, MPH 312-996-4842 nmlina1@uic.edu
Principal Investigator: Konstantin V Slavin, MD

Sponsors and Collaborators

University of Illinois

Investigators

Principal Investigator:

Konstantin V Slavin, MD

University of Illinois

More Information

Additional Information:

Departmental website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Department of Neurosurgery, University of Illinois at Chicago ( Konstantin Slavin, MD )
Study ID Numbers:	UIC 2002-0232
Study First Received:	August 25, 2008
Last Updated:	April 1, 2009
ClinicalTrials.gov Identifier:	NCT00741858 History of Changes
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:

Neural Tube Defects
Estrogens
Contraceptive Agents
Nervous System Malformations
Physiological Effects of Drugs
Nervous System Diseases
Estradiol valerate
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents

Estradiol 17 beta-cypionate
Hormones
Pharmacologic Actions
Estradiol
Arnold-Chiari Malformation
Therapeutic Uses
Estradiol 3-benzoate
Congenital Abnormalities
Polyestradiol phosphate

ClinicalTrials.gov processed this record on February 08, 2010