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A Randomised Controlled Study to Evaluate the Efficacy and Safety of Fibrin Sealant, Vapour Heated, Solvent/Detergent Treated (FS VH S/D 500 s apr) Compared to DuraSeal Dural Sealant as an Adjunct to Sutured Dural Repair in Cranial Surgery

915403
Surgery
Dr. Dennis Oh
Baystate Medical Center 759 Chestnut Street Springfield, MA 01199

The purpose of this study is to evaluate the safety and efficacy of the study drug, FS VH S/D 500 s-apr, compared to DuraSeal Dural Sealant as an additional aid to sutured dural (membrane that covers and protects the brain and spinal cord) closure.

Patients ≥18 years of age undergoing craniotomy/craniectomy for pathological processes in the posterior fossa (PF) or supratentorial (ST) regions of the brain.
Barbara Burkott, RN, BSN, CCRP, CRCP
413-794-1305