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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Integra LifeSciences Corporation
ClinicalTrials.gov Identifier:
NCT01410864
First received: August 4, 2011
Last updated: February 28, 2017
Last verified: February 2017
  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
Dural Sealing Device: DuraSeal Exact Spine Sealant System Other: Control

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

Resource links provided by NLM:


Further study details as provided by Integra LifeSciences Corporation:

Primary Outcome Measures:
  • Post-operative CSF leaks [ Time Frame: 90 days post-operative ]

Secondary Outcome Measures:
  • Post-operative surgical site infections [ Time Frame: 90 days post-operative ]
    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 ]

Enrollment: 924
Study Start Date: August 2011
Study Completion Date: July 2016
Primary Completion Date: July 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   (Adult, Senior)
Sexes Eligible for Study:   All
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

  Show 36 Study Locations
Sponsors and Collaborators
Integra LifeSciences Corporation
  More Information

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: February 28, 2017

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

ClinicalTrials.gov processed this record on July 27, 2017