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DuraSeal Sealant Post Market Study

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ClinicalTrials.gov Identifier: NCT00704340
Recruitment Status : Completed
First Posted : June 24, 2008
Results First Posted : July 28, 2010
Last Update Posted : September 7, 2017
Sponsor:
Collaborator:
Medtronic - MITG
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Elective Cranial Procedures With Dural Incision Device: DuraSeal Dural Sealant System Other: Standard of Care Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 237 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: DuraSeal Sealant Post Market Study
Study Start Date : September 2005
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Arm Intervention/treatment
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




Primary Outcome Measures :
  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. [ 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 :
  1. Percentage of Subjects With Post-operative Surgical Site Infections [ Time Frame: 30 days ]
  2. 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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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

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

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 Posted: June 24, 2008    Key Record Dates
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