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Sponsored by: |
Confluent Surgical |
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Information provided by: | Confluent Surgical |
ClinicalTrials.gov Identifier: | NCT00444067 |
To evaluate a spinal sealant as an adjunct to sutured dural repair compared to standard of care techniques.
Condition | Intervention | Phase |
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Cerebrospinal Fluid Leakage, Subdural |
Device: Spinal Sealant |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment |
Study Start Date: | March 2007 |
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 nause 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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Contact: Vladimir I Scerbin | (781) 693-2305 |
United States, Massachusetts | |
Confluent Surgical, Inc. | Recruiting |
Waltham, Massachusetts, United States, 02451 | |
Contact: Vladimir I Scerbin 781-693-2305 |
Study Director: | Vladimir I Scerbin | Conlfuent Surgical |
Study ID Numbers: | DS3-06-002 |
Study First Received: | March 6, 2007 |
Last Updated: | April 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00444067 |
Health Authority: | United States: Food and Drug Administration |
Prevention of CSF leak |
Hypotension Craniocerebral Trauma Cerebrospinal Fluid Rhinorrhea Cerebrospinal fluid leak Wounds and Injuries Disorders of Environmental Origin Central Nervous System Diseases |
Trauma, Nervous System Brain Diseases Signs and Symptoms Central Nervous System Infections Neurologic Manifestations Subdural Effusion Intracranial Hypotension |
Nervous System Diseases Perimeningeal Infections |