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Study to Evaluate Safety & Effectiveness of Spinal Sealant

This study has been completed.
Sponsor:
Collaborator:
Covidien
Information provided by (Responsible Party):
Covidien ( Confluent Surgical )
ClinicalTrials.gov Identifier:
NCT00444067
First received: March 6, 2007
Last updated: July 17, 2012
Last verified: July 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Cerebrospinal Fluid Leakage, Subdural
 Device: Spinal Sealant
Other: Standard of Care
 Phase 3

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

Further study details as provided by Covidien:

Primary Outcome Measures:
  • Percent(%) Success in Obtaining a Watertight Closure Following Assigned Treatment (Spinal Sealant or Control) [ Time Frame: Intra-operative ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]

    •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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects scheduled for a spinal procedure that requires a dural incision
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00444067

Locations
United States, Massachusetts
Confluent Surgical, Inc.
Waltham, Massachusetts, United States, 02451
Sponsors and Collaborators
Confluent Surgical
Covidien
Investigators
Study Director: Jen Doyle Conlfuent Surgical/Covidien
  More Information

No publications provided

Responsible Party: Covidien ( Confluent Surgical )
ClinicalTrials.gov 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: July 17, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Covidien:
Prevention of CSF leak

Additional relevant MeSH terms:
Cerebrospinal Fluid Rhinorrhea
Intracranial Hypotension
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

ClinicalTrials.gov processed this record on May 16, 2013