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

NCT ID: NCT06899711

Last Updated: 2025-05-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-26
• Study Completion Date: 2028-04-30

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 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

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

External Cranial Prosthesis

Intervention Type: 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.

Interventions

External Cranial Prosthesis

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.

Intervention Type: DEVICE

Other Intervention Names

External Skull Prosthesis; External Post-Operative Skull Prosthesis (ExO-Skull)

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph M Dardick, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Medical Institute

Fernando Gonzalez, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Site Status: RECRUITING

Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Joseph M Dardick, MD

Role: CONTACT

jdardic1@jhmi.edu

314-249-4648

Fernando Gonzalez, MD

Role: CONTACT

fernando.gonzalez@jhu.edu

919-886-1166

Facility Contacts

Joseph M Dardick, MD

Role: primary

jdardic1@jhmi.edu

314-249-4648

Fernando Gonzalez, MD

Role: backup

fernando.gonzalez@jhu.edu

919-886-1166

Joseph M Dardick, MD

Role: primary

jdardic1@jhmi.edu

314-249-4648

Fernando Gonzalez, MD

Role: backup

fernando.gonzalez@jhu.edu

919-886-1166

Other Identifiers

IRB00475054

Identifier Type: -

Identifier Source: org_study_id