DuraSeal Sealant Post Market Study

Integra LifeSciences

Status: Completed

Conditions: Elective Cranial Procedures With Dural Incision

Treatments: Other: Standard of Care; Device: DuraSeal Dural Sealant System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00704340

DRS-05-002

Details and patient eligibility

About

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).

Enrollment: 237 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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237 participants in 2 patient groups

1

Experimental group

Description:

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.

Treatment:

Device: DuraSeal Dural Sealant System

2

Active Comparator group

Description:

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.

Treatment:

Other: Standard of Care