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ID06899711

Study of External Skull Prosthesis to Prevent Sunken Flap Syndrome After Decompressive Craniectomy Evaluating Brain Function Recovery and Cost Effectiveness

Led by Johns Hopkins University · Updated on 2026-05-11

72

Participants Needed

2

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Patients who have undergone decompressive craniectomy may develop a delayed brain function complication called Sunken Flap Syndrome SFS or Syndrome of the Trephined. This condition can cause symptoms such as headaches, weakness, seizures, coma, and permanent brain damage due to loss of normal brain protection after skull removal. This clinical trial aims to evaluate whether placing a custom-made external prosthetic over the skull defect can prevent SFS, improve brain function recovery, and reduce healthcare costs after decompressive craniectomy. Participants may choose to wear a 3D-printed external cranial prosthesis made from materials used in other facial prosthetics. Those who agree will receive the prosthetic at their 4-week post-operative appointment and are asked to wear it as much as possible until their skull repair surgery. All patients, regardless of prosthetic use, will receive standard post-operative care including neurologic assessments and trans-cranial duplex ultrasonography to measure blood flow in the brain arteries at scheduled visits. During the study, participants will attend their routine 2- and 4-week post-craniectomy appointments and pre- and post-skull repair visits. At each visit, brain function will be evaluated through non-invasive testing. Those wearing the prosthetic will also complete a survey regarding their experience after skull repair. The research team will compare the incidence of SFS, neurological recovery, and healthcare utilization between participants who do and do not wear the prosthetic over a 6-month period.

CONDITIONS

Brief Title

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

Research Team

J

Joseph M Dardick, MD

F

Fernando Gonzalez, MD

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