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Evaluate the Safety and Efficacy of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery

2019-09-17 02:47:36 | BioPortfolio

Summary

The objective of the study is to clinically assess the safety and effectiveness of LIQOSEAL® as a means of reducing intra- as well as post-operative CSF leakage in patients undergoing elective cranial intradural surgery with a dural closure procedure to show noninferiority compared to a control group.

Study Design

Conditions

Cerebrospinal Fluid Leak

Intervention

LIQOSEAL, DuraSeal, Adherus

Status

Not yet recruiting

Source

Polyganics BV

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-17T02:47:36-0400

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Medical and Biotech [MESH] Definitions

Discharge of cerebrospinal fluid through a hole through the skull bone most commonly draining from the nose (CEREBROSPINAL FLUID RHINORRHEA) or the ear (CEREBROSPINAL FLUID OTORRHEA).

Tubes inserted to create communication between a cerebral ventricle and the internal jugular vein. Their emplacement permits draining of cerebrospinal fluid for relief of hydrocephalus or other condition leading to fluid accumulation in the ventricles.

Discharge of cerebrospinal fluid through the nose. Common etiologies include trauma, neoplasms, and prior surgery, although the condition may occur spontaneously. (Otolaryngol Head Neck Surg 1997 Apr;116(4):442-9)

Proteins in the cerebrospinal fluid, normally albumin and globulin present in the ratio of 8 to 1. Increases in protein levels are of diagnostic value in neurological diseases. (Brain and Bannister's Clinical Neurology, 7th ed, p221)

Manometric pressure of the CEREBROSPINAL FLUID as measured by lumbar, cerebroventricular, or cisternal puncture. Within the cranial cavity it is called INTRACRANIAL PRESSURE.

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