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RECRUITING
NCT06632587
NA

Timing Impact of Early vs. Late Cranioplasty on Hemicraniectomy Outcomes

Sponsor: Thomas Jefferson University

View on ClinicalTrials.gov

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

PROCEDURE

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.

PROCEDURE

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