Condition: Craniectomy · Trephined Syndrome · Traumatic Brain Injury (TBI) Patients · Sponsor: Johns Hopkins University
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 (DC) is often performed. In this surgery, a large portion of the patient's skull is removed to decrease pressure on the brain and decrease permanent damage. After this surgery, many patients experience sinking of the brain in the skull as the pressure inside the head improves. The skull normally protects the brain from the outside environment. When large parts of the skull are removed, the brain is not able to regulate itself normally. This can lead to a number of problems, such as headaches, weakness, seizures, and even coma and permanent brain damage. This is referred to as "Sunken Flap Synd…
This description comes directly from the study's public registry record.
Joseph M Dardick, MD · 314-249-4648 · jdardic1@jhmi.edu
Fernando Gonzalez, MD · 919-886-1166 · fernando.gonzalez@jhu.edu
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| Johns Hopkins Bayview Medical Center | Baltimore, Maryland, United States | Recruiting |
| Johns Hopkins Hospital | Baltimore, Maryland, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06899711