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Study to Evaluate Safety & Effectiveness of Spinal Sealant

This study has been completed.
Medtronic - MITG
Information provided by (Responsible Party):
Integra LifeSciences Corporation Identifier:
First received: March 6, 2007
Last updated: September 4, 2014
Last verified: September 2014
To evaluate a spinal sealant as an adjunct to sutured dural repair compared to standard of care techniques.

Condition Intervention
Cerebrospinal Fluid Leakage, Subdural
Device: Spinal Sealant
Other: Standard of Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:

Further study details as provided by Integra LifeSciences Corporation:

Primary Outcome Measures:
  • 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:
  • 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

  • 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).

Enrollment: 98
Study Start Date: May 2007
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects scheduled for a spinal procedure that requires a dural incision
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

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
Study First Received: March 6, 2007
Results First Received: July 17, 2012
Last Updated: September 4, 2014

Keywords provided by Integra LifeSciences Corporation:
Prevention of CSF leak

Additional relevant MeSH terms:
Cerebrospinal Fluid Leak
Subdural Effusion
Cerebrospinal Fluid Rhinorrhea
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Perimeningeal Infections
Central Nervous System Infections
Neurologic Manifestations
Craniocerebral Trauma
Trauma, Nervous System
Signs and Symptoms
Wounds and Injuries processed this record on April 28, 2017