NCT00594035

Study to Evaluate Safety and Effectiveness of Spinal Sealant

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: Integra LifeSciences Corporation · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and efficacy of the Spinal Sealant as an adjunct to sutured dural repair compared with standard of care methods (control) to obtain watertight dural closure in patients undergoing spinal surgery.

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.

Conditions

• Spinal Procedure Requiring Dura Incision

Interventions

Type	Name	Description
DEVICE	Spinal Sealant System
DEVICE	Standard of care	Standard of care: devices intended to provide a watertight closure

Timeline

• Start date: 2005-09-01
• Primary completion: 2008-02-01
• Completion: 2008-04-01
• First posted: 2008-01-15
• Last updated: 2017-09-07
• Results posted: 2009-12-03

Locations

1 site across 1 country: United States