The Use of a Novel External Cranial Prosthesis in Patients with Skull Bone Defects in Low- and Middle-income Countries (LMICs)

Introduction: Decompressive Craniectomy (DC) refers to the surgical removal of a portion of the skull cap, aiming for lowering high intracranial pressure. Common indications of DC include traumatic brain injury (TBI), middle cerebral artery (MCA) infarction, and subarachnoid hemorrhage (SAH). Cranioplasty aims to restore esthesis, improve cerebrospinal fluid (CSF) dynamics, and provide intracranial protection. Delayed cranioplasty is associated with lower infection rates. The lack of perioperative care infrastructures such as intensive care units (ICUs) and fully equipped operation rooms (ORs) may generate difficulties in applying protocols of care designed for high-income countries and may be unfeasible in LMICs. An external cranial prosthesis provides a simple, cost-effective solution to these issues.

Methods: We offer multiple modular sizes of this device to fit any craniectomy. Polypropylene was chosen as the material of choice due to its low costs, high ultimate tensile strength, and high Young’s Modulus.

Results: Failure Modes and Effects Analysis (FMEA) was performed to determine the risks posed by the device and how to mitigate these risks. The most common problems that patients may encounter with this device include adding too much pressure on the surgical site, improper customization of the device, and delayed fabrication. These risks have the highest Risk Priority Number (RPN) value due to a high Occurrence Frequency (OCC) since these patients have just undergone surgery following TBI or stroke. The Severity Rating (SEV) of risk dramatically decreases when utilizing this device, which elaborates its effectiveness.

Conclusion : There is an urgent demand for an affordable protective external cranial prosthesis for patients with skull bone defects, especially those who underwent DC in LMICs. This proposed device offers comfort, customization, and affordability for patients with skull defects especially those in LMICs.