Feasibility and Outcomes of 3D-printed External Cranial Orthosis After Craniectomy

Feasibility, Safety and Patient Reported Outcomes of 3D-Printed Externally-applied Cranial Orthosis (PEACO) After Decompression Craniectomy in Clinical Settings: A Retrospective Comparison Study of Monitored Versus Unmonitored Protocols

This study will compare the outcomes of a current clinical implementation of PEACO designed for one-handed donning and doffing with carer-monitoring with a previous prototype (HPPD) requiring carer-donning and doffing with therapist monitoring.

The study aims to:

1. Evaluate the feasibility, safety and clinical outcomes of a 3D-printed externally applied cranial orthosis (PEACO) in a clinical setting (unmonitored protocol)
2. Comparison of device A - 2021 Head Protection Prototype Device (HPPD) (DSRB 2019/00155)-monitored protocol with device B (PEACO).

Inclusion Criteria:

• Unilateral decompressive craniectomy (DC)
• Acute Stroke or traumatic brain injury
• >30 days post DC
• Healed surgical wounds, non-bulging flaps
• Presence of caregiver supervision

Exclusion Criteria:

• Vegetative or minimally responsive state
• Uncontrolled medical illnesses, e.g. sepsis, delirium, active malignancy
• Life expectancy < 6 months
• Unhealed or infected post-DC neurosurgical wounds
• Known allergy to investigational products