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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT06899711
Status
Recruiting
Apply to this trial

Conditions

  • Craniectomy
  • Ischemic Stroke
  • Traumatic Brain Injury (TBI) Patients
  • Trephined Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • External Cranial Prosthesis — DEVICE
    The external cranial prosthesis is a 3D printed external plate that approximates patients' post-craniectomy skull defect. The prosthesis is made from the same material used in other external Craniofacial prostheses. Patients will be counseled on securing it properly and comfortably on their scalp. Patients will be asked to wear this prosthesis as much as possible until Cranioplasty takes place. After Cranioplasty, the participant will be asked to stop wearing the prosthesis.

Study Details

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 Syndrome" (SFS) or "Syndrome of the Trephined" (SoT). After 3-6 months, patients can have the missing skull surgically repaired, which improves and sometimes fixes SFS, but the damage is sometimes too severe to be reversed. There are reports of patients with SFS treated with custom-made prosthetics that cover the missing piece of skull. In this study, the researchers want to see if wearing a custom-made prosthetic can prevent patients from experiencing SFS. Patients will also receive additional non-invasive measurement to see if the prosthetic can improve brain function and recovery. Finally, the researchers want to know if the prosthetic is cost-effective by decreasing the frequency that patients see doctors or receive care to treat SFS. Patients or the patient's medical decision makers will be asked if the patient wants to participate in the study after DC. If the patient or decision maker agrees to participate, the patient will be also asked if the patient wants to wear the prosthetic. The prosthetic is made of a common material used in other facial prosthetics. Patients that agree to wear the prosthetic will have a custom plate made for the participant. All patients will receive the same post-operative care and appointments whether or not the prosthetic is worn. The participant will go to the normally scheduled post-operative doctor's appointments at 2 and 4 weeks after initial DC surgery. Patient's that agree to wear the prosthetic will receive it at the 4-week post-DC appointment. The participant will then be asked to wear it as much as possible, but to let the researchers know if the participant experiences any pain, itching, discomfort or other problems. All patients will also be seen by the patient's physician before and after and after skull repair. At all appointments, patients will receive non-invasive testing of brain function. Recovery and rate of SFS will be compared between patients that do and do not wear the prosthetic. Participants will: * Go to the normally scheduled 2 and 4 week post-DC appointments * Go to the normally scheduled pre- and post-skull repair appointments * Receive additional non-invasive brain health testing at each appointment Participants that agree to wear a prosthetic will: * Receive the custom prosthetic at the 4-week post-DC appointment * Wear the prosthetic as much as possible, including at night * Take a brief survey about the prosthetic at the post-skull repair appointment

Key Dates

Start date
Apr 26, 2025
Status verified
May 2026
Primary completion
Apr 30, 2028
Completion
Apr 30, 2028

Study Design

Enrollment
72 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • No Intervention: No Prosthesis
    Patients that elect not to wear the post-operative skull prosthesis will receive standard-of-care treatment which includes 2-week and 4-week post-operative appointments with neurologic assessments and pre- and post-cranioplasty appointments with neurologic assessments. In addition to their neurologic assessment, the participant will also receive trans-cranial duplex ultrasonography to measure the blood flow velocities in their middle cerebral arteries at each appointment.
  • Experimental: External Cranial Prosthesis (ECP)
    Patients that agree to participate in wearing the post-operative skull prosthesis will receive the prosthesis at their 4 week post-operative appointment. At this time, the participant will be asked to wear the prosthesis at all times, as much as the participant is able, and to notify the investigators of any pain, itching, discomfort, or other problems with the prosthesis. These patients will receive a neurologic assessment at this 4-week appointment and will also receive their standard-of-care 2-week post-craniectomy and pre- and post-cranioplasty appointments with neurologic assessments. In addition to these neurologic assessments, the participant will receive trans-cranial duplex ultrasonography to measure the blood flow velocities in their middle cerebral arteries at each appointment. Finally, patients' will receive a survey at their post-cranioplasty appointment with questions regarding their experience with the external cranial prosthesis.

Primary Outcome Measure

Incidence of Sunken Flap Syndrome [ Time Frame: Up to 6 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Johns Hopkins Bayview Medical CenterBaltimoreMaryland21224
Joseph M Dardick, MD
[email protected]
314-249-4648
Fernando Gonzalez, MD
[email protected]
919-886-1166
Johns Hopkins HospitalBaltimoreMaryland21287
Joseph M Dardick, MD
[email protected]
314-249-4648
Fernando Gonzalez, MD
[email protected]
919-886-1166

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Johns Hopkins Bayview Medical Center· Baltimore, MDJohns Hopkins Hospital· Baltimore, MD

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