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

NARecruitingINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

April 26, 2025

Primary Completion Date

April 30, 2028

Study Completion Date

April 30, 2028

Conditions
CraniectomyTrephined SyndromeTraumatic Brain Injury (TBI) PatientsIschemic Stroke
Interventions
DEVICE

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.

Trial Locations (2)

21224

RECRUITING

Johns Hopkins Bayview Medical Center, Baltimore

21287

RECRUITING

Johns Hopkins Hospital, Baltimore

All Listed Sponsors
lead

Johns Hopkins University

OTHER