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

NCT06899711 | Recruiting DMC FDA Device

• 1 other identifier: IRB00475054
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

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:

• 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

Keywords

Syndrome of the Trephined; Sunken Flap Syndrome; Post-Craniectomy Syndrome; Craniectomy

Outcome Measures

Primary Outcomes (1)

• Incidence of Sunken Flap Syndrome

  Sunken Flap Syndrome will be defined as development of new neurologic symptoms after acute injury and craniectomy that improve quickly post-cranioplasty (ie. between pre- and post-cranioplasty appointments). Changes will be determined based on Glasgow coma scale, brainstem reflex assessment, confrontational strength testing, and Mini-Mental State Exam testing (MMSE). Patients that have improvement in at least one of these modalities will indicate that the patient suffered from SFS and the reported variable will be "incidence of SFS". The incidence of SFS will be compared between the intervention and non-intervention groups using chi-squared analysis.

  Up to 6 months

Secondary Outcomes (5)

• Ratio of Ipsilateral to Contralateral Middle Cerebral Artery Flow Velocity

  Up to 6 months

• Difference in health care utilization for post-craniectomy patients with implementation of ECP

  Up to 6 months

• The effect of ECP on neurologic recovery measured by Glascow Coma Scale (GCS)

  Up to 6 months

• The effect of ECP on neurologic recovery as measured by confrontational strength testing

  Up to 6 months

• The effect of ECP on neurologic recovery as measured by Mini Mental Status Exam

  Up to 6 months

Study Arms (2)

No Prosthesis

NO INTERVENTION

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.

External Cranial Prosthesis (ECP)

EXPERIMENTAL

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.

Device: External Cranial Prosthesis

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.

Also known as: External Skull Prosthesis, External Post-Operative Skull Prosthesis (ExO-Skull)

External Cranial Prosthesis (ECP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18
• Patients must be admitted to Johns Hopkins Hospital or Johns Hopkins Bayview Medical Center

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (2)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

RECRUITING

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Ischemic Stroke

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Stroke; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Joseph M Dardick, MD

  Johns Hopkins Medical Institute

  PRINCIPAL INVESTIGATOR

• Fernando Gonzalez, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph M Dardick, MD

CONTACT

314-249-4648; jdardic1@jhmi.edu

Fernando Gonzalez, MD

CONTACT

919-886-1166; fernando.gonzalez@jhu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: March 28, 2025
• Study Start: April 26, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: May 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)