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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Integra LifeSciences Corporation
Sponsor:
Information provided by (Responsible Party):
Integra LifeSciences Corporation
ClinicalTrials.gov Identifier:
NCT01410864
First received: August 4, 2011
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Dural Sealing
Device: DuraSeal Exact Spine Sealant System
Other: Control
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: DuraSeal Exact Spine Sealant System Post-Approval Study

Further study details as provided by Integra LifeSciences Corporation:

Primary Outcome Measures:
  • Post-operative CSF leaks [ Time Frame: 90 days post-operative ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Post-operative surgical site infections [ Time Frame: 90 days post-operative ] [ Designated as safety issue: Yes ]
    Deep surgical site infections as defined by the Center for Disease Control criteria.

  • Post-operative neurological serious adverse events [ Time Frame: 90 days post-operative ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 884
Study Start Date: August 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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)
  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: NCT01410864

Contacts
Contact: Sheila Smith 781-565-1334 sheila.smith@integralife.com
Contact: Stefani Battaglia 781-565-1265 stefani.battaglia@integralife.com

Locations
United States, California
Recruiting
Los Angeles, California, United States, 90033
Recruiting
Palo Alto, California, United States, 94305
Recruiting
Sacramento, California, United States, 95616
United States, Colorado
Recruiting
Boulder, Colorado, United States, 80302
Recruiting
Colorado Springs, Colorado, United States, 80907
United States, District of Columbia
Recruiting
Washington, District of Columbia, United States, 20037
United States, Illinois
Recruiting
Chicago, Illinois, United States, 60611
United States, Kansas
Recruiting
Kansas City, Kansas, United States, 66160
United States, Louisiana
Recruiting
New Orleans, Louisiana, United States, 70121
United States, Michigan
Recruiting
Royal Oak, Michigan, United States, 48073
United States, Missouri
Recruiting
St. Louis, Missouri, United States, 63130
United States, New Hampshire
Recruiting
Lebanon, New Hampshire, United States, 03766
United States, New York
Recruiting
Syracuse, New York, United States, 13057
United States, Ohio
Recruiting
Cincinnati, Ohio, United States, 45219
Recruiting
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Recruiting
Philadelphia, Pennsylvania, United States, 19140
Recruiting
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Recruiting
Charleston, South Carolina, United States, 29406
United States, Texas
Recruiting
Plano, Texas, United States, 75093
United States, Virginia
Recruiting
Charlottesville, Virginia, United States, 22903
Sponsors and Collaborators
Integra LifeSciences Corporation
  More Information

No publications provided

Responsible Party: Integra LifeSciences Corporation
ClinicalTrials.gov Identifier: NCT01410864     History of Changes
Other Study ID Numbers: COVDRSS0002
Study First Received: August 4, 2011
Last Updated: June 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Integra LifeSciences Corporation:
cerebrospinal fluid leaks
dural opening
dural sealing

ClinicalTrials.gov processed this record on July 24, 2014