DuraSeal Exact Spine Sealant System Post-Approval Study

Completed

• Conditions: Dural Sealing
• Interventions: Device: DuraSeal Exact Spine Sealant System; Other: Control

• Registration Number: NCT01410864
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-04
• Study First Submitted QC: 2011-08-04
• Study First Posted: 2011-08-05
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 924

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DuraSeal Arm	DuraSeal Exact Spine Sealant System	Prospective enrollment of subjects who have received DuraSeal Exact Spinal Sealant System for treatment of an intentional or incidental dural tear during spine surgery.
Control Arm	Control	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)

Primary Outcome Measures

Name	Time	Method
Post-operative CSF leaks	90 days post-operative

Secondary Outcome Measures

Name	Time	Method
Post-operative neurological serious adverse events	90 days post-operative
Post-operative surgical site infections	90 days post-operative	Deep surgical site infections as defined by the Center for Disease Control criteria.