Study to Evaluate Safety & Effectiveness of Spinal Sealant

Not Applicable

Completed

• Conditions: Cerebrospinal Fluid Leakage, Subdural
• Interventions: Device: Spinal Sealant; Other: Standard of Care

• Registration Number: NCT00444067
• Lead Sponsor: Integra LifeSciences Corporation

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2007-03-06
• Study First Submitted QC: 2007-03-06
• Study First Posted: 2007-03-07
• Study Start: 2007-05
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Results First Submitted: 2012-07-17
• Results First Submitted QC: 2012-07-17
• Results First Posted: 2012-08-21
• Status Verified: 2014-09
• Last Update Submitted: 2017-08-07
• Last Update Posted: 2017-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spinal Sealant System	Spinal Sealant	Spinal Sealant System
Standard of Care	Standard of Care	Standard of care methods as an adjunct to sutured dural repair

Primary Outcome Measures

Name	Time	Method
Percent(%) Success in Obtaining a Watertight Closure Following Assigned Treatment (Spinal Sealant or Control)	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.

Trial Locations

Locations (1)

Confluent Surgical, Inc.; 🇺🇸 Bedford, Massachusetts, United States