NCT00704340

DuraSeal Sealant Post Market Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 237 (actual)
• Sponsor: Integra LifeSciences Corporation · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Elective Cranial Procedures With Dural Incision

Interventions

Type	Name	Description
DEVICE	DuraSeal Dural Sealant System	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.
OTHER	Standard of Care	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.

Timeline

• Start date: 2005-09-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2008-06-24
• Last updated: 2017-09-07
• Results posted: 2010-07-28

Locations

1 site across 1 country: United States