CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 237 enrolled
Drug / intervention
DuraSeal Dural Sealant System +1 moredevice
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/NCT00704340
NCT00704340N/ACompleted
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DuraSeal Sealant Post Market Study

Integra LifeSciences Corporation·interventional·Posted Jun 24, 2008·Updated Sep 7, 2017

In Brief

A clinical study evaluating DuraSeal Dural Sealant System and Standard of Care for Elective Cranial Procedures With Dural Incision. Completed, enrolled 237 participants across 1 site.

Detailed Summary

DuraSeal Dural Sealant has been approved as a dural sealant by the FDA for use in cranial and spinal procedures. This study was completed to further evaluate the safety of the DuraSeal Sealant in a post-approval setting as compared to control (defined as methods typically employed by surgeons to seal the dura).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsElective Cranial Procedures With Dural Incision
CountriesUnited States
CollaboratorsMedtronic - MITG

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 24, 2008
Enrollment StartSep 1, 2005
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 18.0 years ago

Interventions

DuraSeal Dural Sealant Systemdevice

The DuraSeal™ Dural Sealant System is a polyethylene glycol (PEG) hydrogel that has been FDA approved as a dural sealant to achieve watertight dural closure in cranial and spinal surgery after primary repair with suturing is complete. It was developed as a means of providing a dural seal by covering small holes around the suture with an absorbable hydrogel. DuraSeal should only be used with autologous duraplasty material.

Standard of Careother

Standard procedure to obtain intraoperative watertight dural closure. These methods could have included additional sutures, adhesive glue, absorbable gelatin sponge, dural substitute, soft tissue patch, or another method typically used by the investigator.