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External Post-Operative Skull Prosthesis to Prevent Sunken Flap Syndrome in Craniectomy Patients

RecruitingNAAges 18 Years - anyAllJohns Hopkins University
NCT06899711 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 see if placing a prosthetic over patients' skull defects can prevent "Sunken Flap Syndrome." The main questions are: 1. Can placing a prosthetic device over patients' skull defects prevent Sunken Flap Syndrome? 2. Can placing a prosthetic device over patients' skull defects decrease healthcare costs? 3. Can placing a prosthetic device over patients' skull defects improve recovery and return of brain function after decompressive craniectomy? Patients that experience traumatic brain injuries, brain bleeds, and large strokes can build up high levels of pressure in the skull. When this pressure can't be controlled with medications, a life-saving surgery called a decompressive hemicraniectomy (

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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
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What it tests

  • External Cranial Prosthesis
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Where

2 sites
Johns Hopkins Bayview Medical Center
Baltimore, United States
Johns Hopkins Hospital
Baltimore, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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