Study to Evaluate Safety & Effectiveness of Spinal Sealant

Integra LifeSciences

Status: Completed

Conditions: Cerebrospinal Fluid Leakage, Subdural

Treatments: Device: Spinal Sealant; Other: Standard of Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT00444067

DS3-06-002

Details and patient eligibility

About

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

Full 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.

Enrollment: 98 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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98 participants in 2 patient groups

Spinal Sealant System

Experimental group

Description:

Spinal Sealant System

Treatment:

Device: Spinal Sealant

Standard of Care

Active Comparator group

Description:

Standard of care methods as an adjunct to sutured dural repair

Treatment:

Other: Standard of Care