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Last Updated: 10/31/2025
A Prospective Study to Evaluate the Protective Effects of External Cranial Prosthesis on Incidence of Sunken Flap Syndrome in Decompressive Craniectomy Patients
Summary: Patients that undergo decompressive craniectomy are at risk of delayed changes in brain function known as Sunken Flap Syndrome or Syndrome of the Trephined. The goal of this clinical trial is to see if placing a prosthetic over patients' skull defects can prevent Sunken Flap Syndrome. The main questions are: 1. Can placing a prosthetic device over patients' skull defects prevent Sunken Flap Syndro...
A Real World Prospective Observational Study on Evaluation the Comprehensive Effects of Polyetheretherketone Cranioplasty and Titanium Cranioplasty After Decompressive Craniectomy
Summary: The objective of this trial is to scientifically evaluate the efficacy of PEEK cranioplasty and titanium cranioplasty. The primary objective is to compare the rate of implant failure (defined as infection, implant exposure and other causes requiring removal of the implanted material) at any time within 12 months after cranioplasty. The secondary objective is to compare the complication rates and n...
Standard Craniectomy Against Laparotomy for the Treatment of Traumatic Rise in Intracranial Pressure and the Effect on Long-term Outcome
Summary: Intractable high intracranial pressures (ICP) are associated with poor functional outcomes and mortality, so the SCALPEL trials aims to evaluate the effect of decompressive craniectomy against decompressive laparotomy to lower those pressures in diffuse TBI. The primary outcome measure for that evaluation is functional outcome after 12 months on the extended Glasgow Outcome Scale (GOS-E).
Last Updated: 10/31/2025