CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 34 enrolled
Drug / intervention
Duragen duraplasty +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00741858
NCT00741858Phase 3Completed
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Prospective Randomized Study of Duragen vs. Duraguard in Chiari Surgery

University of Illinois at Chicago·interventional·Posted Aug 26, 2008·Updated Jul 13, 2015

In Brief

A Phase 3 clinical trial evaluating Duragen duraplasty and Duraguard duraplasty for Chiari Malformation. Completed, enrolled 34 participants across 1 site.

Detailed 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 each material, patient's outcomes, length of surgery and the hospital stay, etc.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChiari Malformation
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 26, 2008
Enrollment StartApr 1, 2003
Primary CompletionDec 1, 2009
Study CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 17.8 years ago

Interventions

Duragen duraplastyprocedure

Posterior cranial fossa repair and enlargement with application of dural patch (Duragen)

Duraguard duraplastyprocedure

Posterior cranial fossa repair and enlargement with application of dural patch (Duraguard)