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OpenTrials
Completed

NCT Number: NCT00444067

Study to Evaluate Safety & Effectiveness of Spinal Sealant

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

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Key information

Conditions

Cerebrospinal Fluid Leakage, Subdural Brain Diseases Central Nervous System Diseases Central Nervous System Infections Infections Nervous System Diseases Perimeningeal Infections Subdural Effusion

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Confluent Surgical, Inc.

Bedford, Massachusetts, 01730, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Spinal Sealant

Device

Spinal Sealant System

Standard of care

Other

Standard of Care

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Integra LifeSciences Corporation

Industry

Collaborators

  • Medtronic - MITG

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Mar 7, 2007
Registry last updated
Sep 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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