DuraSeal Sealant Post Market Study

NCT00704340 | Completed Results

• 1 other identifier: DRS-05-002
• Study Type: interventional
• Target: 237
• Locations: 1 country
• Sites: 1

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).

Conditions

Elective Cranial Procedures With Dural Incision

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Percentage of Subjects With Post-operative Surgical Site Infections

  30 days

• Percentage of Subjects With a Cerebrospinal Fluid (CSF) Leak

  30 days

Study Arms (2)

1

EXPERIMENTAL

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

2

ACTIVE COMPARATOR

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

Interventions

DuraSeal Dural Sealant System 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. DuraSeal should only be used with autologous duraplasty material.

1

Standard of Care OTHER

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.

Also known as: Standard procedure to obtain intraoperative watertight dural closure

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Integra LifeSciences Corporation: lead
• Medtronic - MITG: collaborator

Study Sites (1)

Confluent Surgical

Waltham, Massachusetts, 02451, United States

Location

Related Publications (1)

• Osbun JW, Ellenbogen RG, Chesnut RM, Chin LS, Connolly PJ, Cosgrove GR, Delashaw JB Jr, Golfinos JG, Greenlee JD, Haines SJ, Jallo J, Muizelaar JP, Nanda A, Shaffrey M, Shah MV, Tew JM Jr, van Loveren HR, Weinand ME, White JA, Wilberger JE. A multicenter, single-blind, prospective randomized trial to evaluate the safety of a polyethylene glycol hydrogel (Duraseal Dural Sealant System) as a dural sealant in cranial surgery. World Neurosurg. 2012 Nov;78(5):498-504. doi: 10.1016/j.wneu.2011.12.011. Epub 2011 Dec 10.

  PMID: 22381303 DERIVED

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Director, Medical Affairs
• Organization: Integra LifeSciences

609-275-0500

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2008
• First Posted: June 24, 2008
• Study Start: September 1, 2005
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: September 7, 2017
• Results First Posted: July 28, 2010

Record last verified: 2017-08

Locations

US (1)