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

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ClinicalTrials.gov Identifier: NCT01410864
Recruitment Status : Completed
First Posted : August 5, 2011
Last Update Posted : March 1, 2017
Sponsor:
Information provided by (Responsible Party):
Integra LifeSciences Corporation

Brief Summary:
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 or disease Intervention/treatment
Dural Sealing Device: DuraSeal Exact Spine Sealant System Other: Control

Study Type : Observational
Actual Enrollment : 924 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: DuraSeal Exact Spine Sealant System Post-Approval Study
Study Start Date : August 2011
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


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)




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

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

  2. Post-operative neurological serious adverse events [ Time Frame: 90 days post-operative ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01410864


  Show 36 Study Locations
Sponsors and Collaborators
Integra LifeSciences Corporation

Responsible Party: Integra LifeSciences Corporation
ClinicalTrials.gov Identifier: NCT01410864     History of Changes
Other Study ID Numbers: COVDRSS0002
First Posted: August 5, 2011    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017

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