292
Participants
Start Date
July 8, 2025
Primary Completion Date
June 30, 2027
Study Completion Date
December 31, 2027
Decompressive Craniectomy
"The DC will be performed through a standard trauma incision, a retro-auricular C-shape or a Kempe incision and execute a 15x15 cm craniotomy with a C-shape durotomy. Dural closure will be at the discretion of the surgeon and the availability of resources, including duroplasty with aponeurotic galea, a suturable dural patch, a non-suturable dural patch, or simply a superficial dural cover with hemostatic materials like Surgicel® or Gelfoam®. There are multiple techniques for DC. The elected technique will be at the discretion of the treating neurosurgeon, but only front-parietal-temporal DC will be considered. The removed bone flap may be stored in an abdominal pouch in the right or left upper abdominal quadrants or by freezing in a bone or blood bank freezer."
Expansion Craniotomy
"The EC will be performed through a retro-auricular C-shape incision and executing a 15x15 cm craniotomy with a C-shape durotomy. Dural closure will be at the discretion of the surgeon and the availability of resources, including duroplasty with aponeurotic galea, a suturable dural patch, a non-suturable dural patch, or simply a superficial dural cover with hemostatic materials like Surgicel® or Gelfoam®. The expansion craniotomy will be finished with a cranioplasty using a full set of 3-5 Rialto plates for bone graft closure. The selected technique will be at the discretion of the treating neurosurgeon, but only front-parietal-temporal EC will be considered."
Lead Sponsor
Meditech Foundation
OTHER