Comparing Outcomes Between Early and Standard-of-care Delayed Cranioplasty After Decompressive Hemicraniectomy
Thomas Jefferson University
Summary
This prospective, randomized study aims to comprehensively evaluate the impact of cranioplasty timing on postoperative complications and long-term functional outcomes following decompressive hemicraniectomy (DHC). The primary endpoint focuses on comparing the rates of various postoperative complications, including infection, seizures, return to the operating room, and the need for ventriculoperitoneal shunting, between patients undergoing standard of care cranioplasty (\>3 months after DHC) and those receiving early cranioplasty (within 8 weeks).
Description
This prospective, randomized study aims to comprehensively evaluate the impact of cranioplasty timing on postoperative complications and long-term functional outcomes following decompressive hemicraniectomy (DHC). The primary endpoint focuses on comparing the rates of various postoperative complications, including infection, seizures, return to the operating room, and the need for ventriculoperitoneal shunting, between patients undergoing standard of care cranioplasty (\>3 months after DHC) and those receiving early cranioplasty (within 8 weeks). The primary endpoint involves a comprehensive…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Adults of age greater than or equal to 18 years at the time of acute traumatic injury or source of increased intracranial pressure secondary to stroke or intracranial hemorrhage necessitating decompressive hemicraniectomy (DHC) * Patient's cranial flap fulfills Craniectomy Contour Class A or B after 4 weeks postoperatively (doi:10.1227/ons.0000000000000689) * Medically optimized for general anesthesia/surgery Exclusion Criteria: * Active systemic infection in weeks 6-8 post-DHC leading up to cranioplasty (e.g. pneumonia, urinary tract infection, soft tissue infection,…
Interventions
- ProcedureEarly cranioplasty
Cranioplasty is the surgical procedure to restore the skull after a decompressive hemicraniectomy. The latter procedure is employed as a life-saving measure to relieve intracranial pressure in patients with acute cranial injuries. Early cranioplasty is defined as being performed within 8 weeks following the decompressive hemicraniectomy.
- ProcedureStandard-of-care cranioplasty
Cranioplasty is the surgical procedure to restore the skull after a decompressive hemicraniectomy. The latter procedure is employed as a life-saving measure to relieve intracranial pressure in patients with acute cranial injuries. Standard-of-care cranioplasty is defined as being performed after 3 months following the decompressive hemicraniectomy.
Location
- Thomas Jefferson University HospitalsPhiladelphia, Pennsylvania