Actively Recruiting
A Prospective Study to Evaluate the Protective Effects of External Cranial Prosthesis on Incidence of Sunken Flap Syndrome in Decompressive Craniectomy Patients
Led by Johns Hopkins University · Updated on 2026-05-11
72
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Patients who have undergone decompressive craniectomy may develop a delayed brain function complication called Sunken Flap Syndrome (SFS) or Syndrome of the Trephined. This condition can cause symptoms such as headaches, weakness, seizures, coma, and permanent brain damage due to loss of normal brain protection after skull removal. This clinical trial aims to evaluate whether placing a custom-made external prosthetic over the skull defect can prevent SFS, improve brain function recovery, and reduce healthcare costs after decompressive craniectomy. Participants may choose to wear a 3D-printed external cranial prosthesis made from materials used in other facial prosthetics. Those who agree will receive the prosthetic at their 4-week post-operative appointment and are asked to wear it as much as possible until their skull repair surgery. All patients, regardless of prosthetic use, will receive standard post-operative care including neurologic assessments and trans-cranial duplex ultrasonography to measure blood flow in the brain arteries at scheduled visits. During the study, participants will attend their routine 2- and 4-week post-craniectomy appointments and pre- and post-skull repair visits. At each visit, brain function will be evaluated through non-invasive testing. Those wearing the prosthetic will also complete a survey regarding their experience after skull repair. The research team will compare the incidence of SFS, neurological recovery, and healthcare utilization between participants who do and do not wear the prosthetic over a 6-month period.
CONDITIONS
Brief Title
External Post-Operative Skull Prosthesis to Prevent Sunken Flap Syndrome in Craniectomy Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age > 18
- Patients admitted to Johns Hopkins Hospital or Johns Hopkins Bayview Medical Center
- Patients who have undergone decompressive hemicraniectomy within 2 weeks prior to consent (before the 2-week post-craniectomy assessment)
You will not qualify if you...
- Patients who undergo bilateral decompressive hemicraniectomy
- Patients who undergo suboccipital decompressive craniectomy
- Patients with a 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 2 weeks after decompressive hemicraniectomy
Participants are screened for eligibility to participate in the trial.
1 screening visit
Duration - Up to 4 weeks post-craniectomy
Participants receive standard post-operative neurologic assessments and trans-cranial duplex ultrasonography to measure blood flow velocities in the middle cerebral arteries.
2 visits at 2 and 4 weeks post-craniectomy
Duration - From 4 weeks post-craniectomy until cranioplasty
Participants who elect to wear the external cranial prosthesis receive it at the 4-week post-operative visit and are asked to wear it as much as possible until cranioplasty. They are monitored for any discomfort or issues with the prosthesis.
1 visit at 4 weeks post-craniectomy for prosthesis fitting
Duration - At time of cranioplasty and immediate post-operative period
Participants undergo cranioplasty surgery and receive neurologic assessments and ultrasonography before and after the procedure. Participants wearing the prosthesis stop wearing it after cranioplasty and complete a survey about their experience.
2 visits (pre- and post-cranioplasty)
Duration - Up to 6 months after cranioplasty
Participants continue neurologic assessments and ultrasonography to monitor recovery and the incidence of sunken flap syndrome.
Multiple follow-up visits up to 6 months post-cranioplasty
Trial Site Locations
Total: 2 locations
1
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Actively Recruiting
2
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
J
Joseph M Dardick, MD
F
Fernando Gonzalez, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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