Using a prosthetic to prevent complications after skull surgery
Official title: A Prospective Study to Evaluate the Protective Effects of External Cranial Prosthesis on Incidence of Sunken Flap Syndrome in Decompressive Craniectomy Patients
Run by Johns Hopkins University · NCT06899711 · Data updated 2026-11-12
This study is testing if a special helmet can help people who had skull surgery avoid complications and recover better.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 72 (estimated) |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 2 sites (Baltimore, Maryland and 1 other locations) |
| Status | Recruiting |
| Started | April 26, 2025 |
| Main results expected | April 2028 |
| Study ends | April 2028 |
| Registry record updated | May 11, 2026 |
| Trial ID | NCT06899711 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 who have recently undergone decompressive hemicraniectomy.
✕Probably not a fit
Patients who have undergone bilateral decompressive hemicraniectomy or have certain pre-existing conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While the specific use of an external cranial prosthesis is novel, similar approaches in managing post-operative complications have shown promise in other studies.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.