A randomized controlled trial to evaluate the safety and efficacy of a study drug (FS VH S/D 500 s apr) vs. sealant in cranial surgery

Dennis Oh, MD
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