Using a prosthetic to prevent complications after skull surgery
A Prospective Study to Evaluate the Protective Effects of External Cranial Prosthesis on Incidence of Sunken Flap Syndrome in Decompressive Craniectomy Patients
NA · Johns Hopkins University · NCT06899711
This study is testing if a special helmet can help people who had skull surgery avoid complications and recover better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University (other) |
| Locations | 2 sites (Baltimore, Maryland and 1 other locations) |
| Trial ID | NCT06899711 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether an external cranial prosthesis can prevent Sunken Flap Syndrome in patients who have undergone decompressive hemicraniectomy. The study aims to determine if this intervention can also reduce healthcare costs and improve recovery outcomes for patients with traumatic brain injuries, brain bleeds, or large strokes. Participants will be monitored for changes in brain function and overall health following the placement of the prosthetic device. The trial is conducted at Johns Hopkins Hospital and Johns Hopkins Bayview Medical Center.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 who have recently undergone decompressive hemicraniectomy.
Not a fit: Patients who have undergone bilateral decompressive hemicraniectomy or have certain pre-existing conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery and quality of life for patients after craniectomy.
How similar studies have performed: While the specific use of an external cranial prosthesis is novel, similar approaches in managing post-operative complications have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Baltimore, Maryland and 1 other locations
- Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States (RECRUITING)
- Johns Hopkins Hospital — Baltimore, Maryland, United States (RECRUITING)
Study contacts
- Principal investigator: Joseph M Dardick, MD — Johns Hopkins Medical Institute
- Study coordinator: Joseph M Dardick, MD
- Email: jdardic1@jhmi.edu
- Phone: 314-249-4648
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Craniectomy, Trephined Syndrome, Traumatic Brain Injury Patients, Ischemic Stroke, Syndrome of the Trephined, Sunken Flap Syndrome, Post-Craniectomy Syndrome