DuraSeal Sealant Post Market Study

Study Overview
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Brief Summary
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DuraSeal Dural Sealant has been approved as a dural sealant by the FDA for use in cranial and spinal procedures. This study was completed to further evaluate the safety of the DuraSeal Sealant in a post-approval setting as compared to control (defined as methods typically employed by surgeons to seal the dura).

Official Title
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DuraSeal Sealant Post Market Study

Conditions
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Elective Cranial Procedures With Dural Incision

Intervention / Treatment
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* Device: DuraSeal Dural Sealant System
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is between 18 and 75 years of age Patient is scheduled for an elective cranial procedure that entails a dural incision Evidence of intraoperative non-watertight closure

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>DuraSeal Dural Sealant System - FDA Approved Device: The DuraSeal™ Dural Sealant System is a polyethylene glycol (PEG) hydrogel that has been FDA approved as a dural sealant to achieve watertight dural closure in cranial and spinal surgery after primary repair with suturing is complete. It was developed as a means of providing a dural seal by covering small holes around the suture with an absorbable hydrogel. | Device: DuraSeal Dural Sealant System<br>* The DuraSeal™ Dural Sealant System is a polyethylene glycol (PEG) hydrogel that has been FDA approved as a dural sealant to achieve watertight dural closure in cranial and spinal surgery after primary repair with suturing is complete. It was developed as a means of providing a dural seal by covering small holes around the suture with an absorbable hydrogel. DuraSeal should only be used with autologous duraplasty material.<br>|
| Active Comparator: 2<br>Standard of Care (control): Standard procedure to obtain intraoperative watertight dural closure. These methods could have included additional sutures, adhesive glue, absorbable gelatin sponge, dural substitute, soft tissue patch, or another method typically used by the investigator. | Other: Standard of Care<br>* Standard procedure to obtain intraoperative watertight dural closure. These methods could have included additional sutures, adhesive glue, absorbable gelatin sponge, dural substitute, soft tissue patch, or another method typically used by the investigator.<br>* Other names: Standard procedure to obtain intraoperative watertight dural closure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With Surgical Wound Complications, Central Nervous System Events, and Neurosurgical Complications Related to Unplanned Intervention or Return to the Operating Room. | Surgical Wound Complications; Superficial incisional surgical site infection (SSI) Deep incisional SSI Organ/Space SSI Late incisional infection: superficial incisional infection that occurs more than 31 but less than 38 days after surgery Poor wound healing Central Nervous System Events; Cerebrospinal Fluid (CSF) leak Hydrocephalus Bacterial meningitis Aseptic meningitis In addition, any complication related to the neurosurgical procedure that required unplanned intervention (i.e., minimally invasive procedures) or return to the operating room was counted. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With Post-operative Surgical Site Infections |  | 30 days | 
| Percentage of Subjects With a Cerebrospinal Fluid (CSF) Leak | As determined from clinical diagnosis by one of the following methods: CSF leak or pseudomeningocele related surgical intervention (i.e., breaking skin) within 30 days post-operation CSF leak confirmation by diagnostic testing within 30 days post-operation CSF leak confirmation by clinical evaluation including physical examination of the surgical site within 30 days post-operation | 30 days |