DuraSeal Sealant Post Market Study

Not Applicable

Completed

• Conditions: Elective Cranial Procedures With Dural Incision
• Interventions: Device: DuraSeal Dural Sealant System; Other: Standard of Care

• Registration Number: NCT00704340
• Lead Sponsor: Integra LifeSciences Corporation

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2008-06-23
• Study First Submitted QC: 2008-06-23
• Study First Posted: 2008-06-24
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Results First Submitted: 2010-04-26
• Results First Submitted QC: 2010-07-27
• Results First Posted: 2010-07-28
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-07
• Last Update Posted: 2017-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 237

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	DuraSeal Dural Sealant System	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.
2	Standard of Care	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With Surgical Wound Complications, Central Nervous System Events, and Neurosurgical Complications Related to Unplanned Intervention or Return to the Operating Room.	30 days	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects With Post-operative Surgical Site Infections	30 days
Percentage of Subjects With a Cerebrospinal Fluid (CSF) Leak	30 days	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

Trial Locations

Locations (1)

Confluent Surgical; 🇺🇸 Waltham, Massachusetts, United States