Study to Evaluate Safety and Effectiveness of Spinal Sealant

Study Overview
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Brief Summary
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To evaluate the safety and efficacy of the Spinal Sealant as an adjunct to sutured dural repair compared with standard of care methods (control) to obtain watertight dural closure in patients undergoing spinal surgery.

Detailed Description
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Neurosurgical procedures in the spine often involve incision of the dura mater to access the spinal cord. If the dural incision is not properly repaired and watertight closure is not achieved cerebrospinal fluid (CSF) can escape presenting a risk for significant morbidity. The most frequent complication of CSF leak is recurring headache complicated with symptoms of nausea and vomiting. Furthermore fluid collection under skin prevents proper wound healing and may lead to wound breakdown and infection of the incision or both. Persistent CSF leak has also been associated with the development of cerebellar hemorrhage and subdural hematoma. Primary repair and watertight closure are paramount to minimizing risk and sequelae associated with CSF leak.

Official Title
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A Prospective, Multi-Center, Randomized Controlled Study to Compare the Spinal Sealant System as an Adjunct to Sutured Dural Repair With Standard of Care Methods During Spinal Surgery

Conditions
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Spinal Procedure Requiring Dura Incision

Intervention / Treatment
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* Device: Spinal Sealant System
* Device: Standard of care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are scheduled for an elective spinal procedure that requires a dural incision will be considered for study participation. Patient requires a procedure that involving surgical wound classification Class 1/Clean (per CDC criteria) Presence of a non-watertight dural closure, either spontaneously or upon Valsala maneuver at 20-25 cm H20 for 5-10 seconds. Exclusion Criteria: Active spinal and/or systemic infection Patient requires additional spinal surgery within the study time period Patient has had a previous spinal surgery involving dural exposure and/or entry at the same level(s) as the study procedure Patient has a pre-existing external lumbar CSF drain or internal CSF shunt Patient is participating in a clinical trial of another investigational device or drug Patient with creatinine > 2.0 mg/dL Patient with total bilirubin > 2.5 mg/dL Pregnant or breast-feeding females or females who wish to become pregnant during the length of study participation Patient has been treated with chronic steroid therapy (>4 weeks) unless discontinued more than 6 weeks prior to surgery Patient has documented history or significant coagulopathy with a PTT >35 sec, PT/INR >1.2, receiving asprin, or NSAIDS at the time of surgery Patient receiving warfarin or heparin at the time of surgery Patient has a diagnosed and documented compromised immune system and/or autoimmune disease Patient has has chemotherapy treatment within 6 months prior to, or planned during the study Patient has had prior radiation treatment to the surgical site or has planned radiation therapy within 30 days post procedure Patient has known malignancy or other condition with prognosis shorter than 6 months Patients with documented history of uncontrolled diabetes Patient requires use of synthetic or non-autologous duraplasty material Patient has a gap greater than 2mm remaining after primary dural closure Patient has undergone laminoplasty decompression Patient has undergone a syringomyelia procedure where the shunt is not placed in the subarachnoid position Patient has undergone a Chiari Malformation procedure that does not entail a dural incision at or below the C1 level The investigator determines that participation in the study may jeopardize the safety or welfare of the patient The investigator determines that the patient should not be included in the study for reason(s) not already specified

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Spinal Sealant | Device: Spinal Sealant System<br> <br> |
| Active Comparator: 2<br>Standard of care | Device: Standard of care<br>* Standard of care: devices intended to provide a watertight closure<br>* Other names: (i.e. devices intended to provide a watertight closure);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Watertight Dural Closure | Number of subjects displaying a watertight dural closure after assigned treatment intra-operatively. | Intra-Operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal procedure, Dura incision