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DuraSeal Sealant Post Market Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00704340
First Posted: June 24, 2008
Last Update Posted: September 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medtronic - MITG
Information provided by (Responsible Party):
Integra LifeSciences Corporation
  Purpose
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).

Condition Intervention
Elective Cranial Procedures With Dural Incision Device: DuraSeal Dural Sealant System Other: Standard of Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: DuraSeal Sealant Post Market Study

Further study details as provided by Integra LifeSciences Corporation:

Primary Outcome Measures:
  • Percentage of Subjects With Surgical Wound Complications, Central Nervous System Events, and Neurosurgical Complications Related to Unplanned Intervention or Return to the Operating Room. [ Time Frame: 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:
  • Percentage of Subjects With Post-operative Surgical Site Infections [ Time Frame: 30 days ]
  • Percentage of Subjects With a Cerebrospinal Fluid (CSF) Leak [ Time Frame: 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


Enrollment: 237
Study Start Date: September 2005
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1

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
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.
Active Comparator: 2

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
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 Name: Standard procedure to obtain intraoperative watertight dural closure

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00704340


Locations
United States, Massachusetts
Confluent Surgical
Waltham, Massachusetts, United States, 02451
Sponsors and Collaborators
Integra LifeSciences Corporation
Medtronic - MITG
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Integra LifeSciences Corporation
ClinicalTrials.gov Identifier: NCT00704340     History of Changes
Other Study ID Numbers: DRS-05-002
First Submitted: June 23, 2008
First Posted: June 24, 2008
Results First Submitted: April 26, 2010
Results First Posted: July 28, 2010
Last Update Posted: September 7, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Gelatin Sponge, Absorbable
Hemostatics
Coagulants