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Therapeutic Areas: Oncology | Neurology
Disease Category: Brain Cancer

Trial Information

An Exploratory Phase 2 Study Evaluating the Efficacy and Safety of Fibrin Sealant, Vapor Heated, Solvent/Detergent Treated (FS VH S/D) 500 S-APR for the Sealing of Dura Defect Sutures in Posterior Fossa Surgery

 You/your child have/has been asked to participate in this research study because you are/your child is scheduled to undergo brain surgery. In order to perform the brain surgery, the surgeon will cut through your/your child’s skull (known as craniotomy) and through the dura (one of the tissue layers covering the brain). The space between the dura and the brain is filled with cerebral spinal fluid (CSF). The use of a sealant on top of the sutures used to close the opening in the dura may help control CSF leakage after your/your child’s surgery. The product to be studied will be referred to as FS VH S/D 500 s-apr. The main purpose of this study is to see if FS VH S/D 500 s-apr works in controlling CSF leakage after brain surgery. This study will also look at the occurrence of infection, adverse events, and procedures required to treat CSF leakage after surgery.

Patient Inclusion/Exclusion Criteria:

- See http://clinicaltrials.coh.org for additional information.

City of Hope
1500 East Duarte Road
Duarte, CA 91010-3000
Phone: 866-896-HOPE (4673)

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