Status:
RECRUITING
External Post-Operative Skull Prosthesis to Prevent Sunken Flap Syndrome in Craniectomy Patients
Lead Sponsor:
Johns Hopkins University
Conditions:
Craniectomy
Trephined Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Patients that undergo decompressive craniectomy are at risk of delayed changes in brain function known as "Sunken Flap Syndrome" or "Syndrome of the Trephined." The goal of this clinical trial is to s...
Eligibility Criteria
Inclusion
- Age \> 18
- Patients must be admitted to Johns Hopkins Hospital or Johns Hopkins Bayview Medical Center
- Patients must have undergone decompressive hemicraniectomy within 2 weeks of consent for inclusion in the study (before the initial 2 week post-craniectomy assessment)
Exclusion
- Patients that undergo bilateral decompressive hemicraniectomy
- Patients that undergo suboccipital decompressive craniectomy
- Patients with pre-existing diagnosis of hydrocephalus
- Patients with a ventriculoperitoneal, ventriculoatrial, or other permanent cerebrospinal fluid shunt
- Patients with an open external ventricular drain at the time of their 2 week post-craniectomy assessment
Key Trial Info
Start Date :
April 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT06899711
Start Date
April 26 2025
End Date
April 1 2028
Last Update
May 4 2025
Active Locations (2)
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1
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
2
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287