DuraSeal Sealant Post Market Study

This study has been completed.
Sponsor:
Collaborator:
Covidien
Information provided by (Responsible Party):
Covidien ( Confluent Surgical )
ClinicalTrials.gov Identifier:
NCT00704340
First received: June 23, 2008
Last updated: November 7, 2013
Last verified: November 2013
  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 Blind (Subject)
Primary Purpose: Treatment
Official Title: DuraSeal Sealant Post Market Study

Resource links provided by NLM:


Further study details as provided by Covidien:

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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
  • Percentage of Subjects With a Cerebrospinal Fluid (CSF) Leak [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

    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.
Other Name: DuraSeal Dural Sealant System
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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00704340

Locations
United States, Massachusetts
Confluent Surgical
Waltham, Massachusetts, United States, 02451
Sponsors and Collaborators
Confluent Surgical
Covidien
  More Information

No publications provided by Covidien

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Covidien ( Confluent Surgical )
ClinicalTrials.gov Identifier: NCT00704340     History of Changes
Other Study ID Numbers: DRS-05-002
Study First Received: June 23, 2008
Results First Received: April 26, 2010
Last Updated: November 7, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Gelatin Sponge, Absorbable
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014