DuraSeal Exact Spine Sealant System Post-Approval Study

Study Overview
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Brief Summary
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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.

Official Title
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DuraSeal Exact Spine Sealant System Post-Approval Study

Conditions
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Dural Sealing

Intervention / Treatment
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* Device: DuraSeal Exact Spine Sealant System
* Other: Control


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DuraSeal Arm<br>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<br>* DuraSeal Exact Spine Sealant System will be administered to those eligible patients, to treat a dural opening.<br>|
| Control Arm<br>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<br>* Devices or drugs used to seal the dura (other than DuraSeal)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative CSF leaks |  | 90 days post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative surgical site infections | Deep surgical site infections as defined by the Center for Disease Control criteria. | 90 days post-operative | 
| Post-operative neurological serious adverse events |  | 90 days post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cerebrospinal fluid leaks, dural opening, dural sealing