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Timing Impact of Early vs. Late Cranioplasty on Hemicraniectomy Outcomes
Sponsor: 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).
Official title: Comparing Outcomes Between Early and Standard-of-care Delayed Cranioplasty After Decompressive Hemicraniectomy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
44
Start Date
2024-09-01
Completion Date
2027-09-01
Last Updated
2025-07-23
Healthy Volunteers
Yes
Interventions
Early 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.
Standard-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.
Locations (1)
Thomas Jefferson University Hospitals
Philadelphia, Pennsylvania, United States