Study to Evaluate Safety & Effectiveness of Spinal Sealant

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. Identifier: NCT00444067
Recruitment Status : Completed
First Posted : March 7, 2007
Results First Posted : August 21, 2012
Last Update Posted : September 7, 2017
Medtronic - MITG
Information provided by (Responsible Party):
Integra LifeSciences Corporation

Brief Summary:
To evaluate a spinal sealant as an adjunct to sutured dural repair compared to standard of care techniques.

Condition or disease Intervention/treatment Phase
Cerebrospinal Fluid Leakage, Subdural Device: Spinal Sealant Other: Standard of Care Not Applicable

Detailed Description:
Neurosurgical procedures in the spine often involve incision of the dura mater to access the spinal cord. If the dural incision is not properly repaired and watertight closure is not achieved cerebrospinal fluid (CSF) can escape presenting a risk for significant morbidity. The most frequent complication of CSF leak is recurring headache complicated with symptoms of nausea and vomiting. Furthermore fluid collection under skin prevents proper wound healing and may lead to wound breakdown and infection of the incision or both. Persistent CSF leak has also been associated with the development of cerebellar hemorrhage and subdural hematoma. Primary repair and watertight closure are paramount to minimizing risk and sequelae associated with CSF leak.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-Center, Randomized Controlled Study to Compare the Spinal Sealant System as an Adjunct to Sutured Dural Repair With Standard of Care Methods During Spinal Surgery
Study Start Date : May 2007
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Spinal Sealant System
Spinal Sealant System
Device: Spinal Sealant
Spinal Sealant System

Active Comparator: Standard of Care
Standard of care methods as an adjunct to sutured dural repair
Other: Standard of Care
Standard of Care

Primary Outcome Measures :
  1. Percent(%) Success in Obtaining a Watertight Closure Following Assigned Treatment (Spinal Sealant or Control) [ Time Frame: Intra-operative ]

    Percent(%) success in obtaining a watertight closure following assigned treatment (Spinal Sealant or Control) where success is defined as:

    A watertight closure of the dural repair intraoperatively after study treatment, confirmed by Valsalva maneuver at 20-25 cm H2O for 5-10 seconds.

Other Outcome Measures:
  1. Incidence of Post-Operative CSF Leaks [ Time Frame: 90 Days ]

    Percentage of participants with CSF leaks within 90 days post-operatively as determined from clinical diagnosis by one of the following methods:

    • CSF leak or pseudomeningocele related surgical intervention (i.e., breaking skin) within 90 days post-procedure; or
    • CSF leak confirmation by diagnostic testing within 90 days post-procedure; or
    • CSF leak confirmation by clinical evaluation within 90 days post-procedure

  2. Incidence of Post-Operative Surgical Site Infections (SSIs) [ Time Frame: 90 Days ]

    •Percentage of participants who incur an SSI within 90 days post-procedure determined by clinical diagnosis

    SSIs were diagnosed and classified in accordance with the Centers for Disease Control (CDC) criteria for evaluation and diagnosis of nosocomial surgical site infections and were classified as one of the following (Superficial, Deep or Organ/Space).

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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

Inclusion Criteria:

  • Subjects scheduled for a spinal procedure that requires a dural incision

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 identifier (NCT number): NCT00444067

United States, Massachusetts
Confluent Surgical, Inc.
Bedford, Massachusetts, United States, 01730
Sponsors and Collaborators
Integra LifeSciences Corporation
Medtronic - MITG
Study Director: Jen Doyle Conlfuent Surgical/Covidien

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Integra LifeSciences Corporation Identifier: NCT00444067     History of Changes
Other Study ID Numbers: DS3-06-002
First Posted: March 7, 2007    Key Record Dates
Results First Posted: August 21, 2012
Last Update Posted: September 7, 2017
Last Verified: September 2014

Keywords provided by Integra LifeSciences Corporation:
Prevention of CSF leak

Additional relevant MeSH terms:
Cerebrospinal Fluid Leak
Cerebrospinal Fluid Rhinorrhea
Subdural Effusion
Neurologic Manifestations
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Signs and Symptoms
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Perimeningeal Infections
Central Nervous System Infections