Clinical Trial: Study to Evaluate Safety & Effectiveness of Spinal Sealant

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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

Detailed Summary: 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.
Sponsor: Integra LifeSciences Corporation

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

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Integra LifeSciences Corporation

Dates:
Date Received: March 6, 2007
Date Started: May 2007
Date Completion:
Last Updated: September 4, 2014
Last Verified: September 2014