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

Launched by JOHNS HOPKINS UNIVERSITY · Mar 21, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating whether using a custom-made prosthetic device can help prevent a condition called "Sunken Flap Syndrome" in patients who have had a type of surgery called decompressive craniectomy. This surgery is performed to relieve pressure on the brain when someone has experienced severe trauma, bleeding, or stroke. After such surgery, some patients may face problems like headaches, weakness, or even more serious issues because their brain doesn't have the protection of the skull. The trial aims to see if wearing the prosthetic can improve recovery, brain function, and potentially lower healthcare costs by reducing the need for additional medical visits.

To be eligible for this study, participants need to be adults over 18 who have had a decompressive craniectomy within the last two weeks and are being treated at Johns Hopkins Hospital or Johns Hopkins Bayview Medical Center. If someone decides to join the study and wear the prosthetic, they will receive it about four weeks after their surgery and will be asked to wear it as much as possible. Throughout the study, all participants will have regular check-ups to monitor their recovery and brain function, regardless of whether they wear the prosthetic or not. This research could provide valuable insights into improving care for patients recovering from serious brain injuries.

Gender

ALL

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