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Clinical Trials/NCT01410864
NCT01410864CompletedNot Applicable

DuraSeal Exact Spine Sealant System Post-Approval Study

Integra LifeSciences Corporation0 sites924 target enrollmentStarted: August 2011Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
924
Primary Endpoint
Post-operative CSF leaks
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Other

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Outcomes

Primary Outcomes

Post-operative CSF leaks

Time Frame: 90 days post-operative

Secondary Outcomes

  • Post-operative surgical site infections(90 days post-operative)
  • Post-operative neurological serious adverse events(90 days post-operative)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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DuraSeal Exact Spine Sealant System... | Clinical Trial