DuraSeal Exact Spine Sealant System Post-Approval Study (DuraSeal PAS)

February 28, 2017 updated by: Integra LifeSciences Corporation
This is a non-randomized, post-approval study to further evaluate the rate of post-operative Cerebral Spinal Fluid (CSF) leaks in subjects who undergo a spinal procedure and receive DuraSeal Exact Spine Sealant System.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

924

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85023
    • California
      • Los Angeles, California, United States, 90033
      • Sacramento, California, United States, 95616
      • San Francisco, California, United States, 94143
      • San Jose, California, United States, 95128
      • Stanford, California, United States, 94305
    • Colorado
      • Boulder, Colorado, United States, 80302
      • Colorado Springs, Colorado, United States, 80907
      • Denver, Colorado, United States, 80045
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
    • Florida
      • Tampa, Florida, United States, 33606
      • Tampa, Florida, United States, 33637
    • Georgia
      • Atlanta, Georgia, United States, 30303
    • Illinois
      • Chicago, Illinois, United States, 60611
    • Kansas
      • Kansas City, Kansas, United States, 66160
    • Kentucky
      • Louisville, Kentucky, United States, 40295
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
    • Maryland
      • Baltimore, Maryland, United States, 21211
    • Massachusetts
      • Boston, Massachusetts, United States, 02120
    • Michigan
      • Royal Oak, Michigan, United States, 48073
    • Missouri
      • St. Louis, Missouri, United States, 63130
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03766
    • New York
      • East Syracuse, New York, United States, 13057
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
      • Durham, North Carolina, United States, 27708
    • Ohio
      • Cincinnati, Ohio, United States, 45219
      • Cleveland, Ohio, United States, 44106
      • Columbus, Ohio, United States, 43210
    • Oregon
      • Bend, Oregon, United States, 97701
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
      • Pittsburgh, Pennsylvania, United States, 15212
      • Pittsburgh, Pennsylvania, United States, 15213
    • South Carolina
      • Charleston, South Carolina, United States, 29406
    • Texas
      • Plano, Texas, United States, 75093
    • Virginia
      • Charlottesville, Virginia, United States, 22903
    • Washington
      • Seattle, Washington, United States, 98122

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

DuraSeal group will be patients that undergo a spinal procedure where a dural opening occurrs and is treated with DuraSeal Exact Spine Sealant System. Control group will be patients that have undergone a spinal procedure where a dural opening occurred and was treated with anything other than DuraSeal Sealant (Spine or Dural). These subjects may be enrolled retrospectively (through a chart review of past cases) or prospectively.

Description

Inclusion Criteria:

  • Subject is 18 years of age or older

  • Subject had a spinal procedure where a dural opening (either intentional or incidental) occurred and was treated with either:

    • DuraSeal™ Exact Spine Sealant (DuraSeal™ Sealant group ONLY) OR
    • Any other method of sealing the dura with the exception of DuraSeal™ Sealant -either spinal or cranial. (Control group ONLY)

  • Subject, or authorized representative, has been informed of the nature of the study and has provided written informed consent approved by the appropriate Institutional Review Board (IRB) of the respective clinical site prior to the collection of study data.

    • Prospective subjects: Consent must be obtained within 24 hours of surgery stop time.
    • Retrospective subjects (Control group specific): IRB approval may be granted to individual sites to waive requirement for informed consent.

Exclusion Criteria:

  • The investigator determines that the subject will not be able to comply with the required follow-up visits (not required if subject is being enrolled retrospectively- control group ONLY)
  • Pregnant or breastfeeding females (as documented in the medical records; no testing beyond the site's standard of care is required)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
DuraSeal Arm
Prospective enrollment of subjects who have received DuraSeal Exact Spinal Sealant System for treatment of an intentional or incidental dural tear during spine surgery.
Device: DuraSeal Exact Spine Sealant System
DuraSeal Exact Spine Sealant System will be administered to those eligible patients, to treat a dural opening.
Control Arm
Subjects who have undergone a spinal procedure where techniques other than DuraSeal were administered for the treatment of either an intentional or incidental opening of the dura may be enrolled either prospectively or retrospectively (via medical record screening)
Other: Control
Devices or drugs used to seal the dura (other than DuraSeal)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Post-operative CSF leaks
Time Frame: 90 days post-operative
90 days post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative surgical site infections
Time Frame: 90 days post-operative
Deep surgical site infections as defined by the Center for Disease Control criteria.
90 days post-operative
Post-operative neurological serious adverse events
Time Frame: 90 days post-operative
90 days post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Integra LifeSciences Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

August 4, 2011

First Submitted That Met QC Criteria

August 4, 2011

First Posted (Estimate)

August 5, 2011

Study Record Updates

Last Update Posted (Actual)

March 1, 2017

Last Update Submitted That Met QC Criteria

February 28, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • COVDRSS0002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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