A single-arm feasibility trial evaluating a protein-based scaffold system with tissue transfer for the reconstruction of skull fractures

This study is an open label single arm trial coordinated by the Investigators at the Princess Alexandra Hospital (PAH) in Woolloongabba (Queensland, Australia), the Australian Centre for Complex Integrated Surgical Solutions at the Translational Research Institute (Queensland, Australia) and the Centre for Regenerative Medicine at the Institute of Health and Biomedical Innovation in Kelvin Grove (Queensland, Australia). The primary purpose of this study is to assess the feasibility of surgical placement of a new protein scaffold in conjunction with free tissue transfer for bone reconstruction in patients who have an acquired skull defect secondary to trauma, malignancy or infection. Experimental data suggests augmented bone regeneration of this new protein scaffold when combined with autologous vascularised free tissue from the subject. It is hypothesised that this method of reconstruction will result in superior regeneration of skull bone with improved cosmesis at a reduced cost to hospital and patient. This will be assessed through pre-and post-operative CT imaging to quantify bone regeneration. This will be compared to previous types of skull reconstruction in terms of functionality (i.e. cosmesis and patient satisfaction) and financial implications (i.e. costs associated with operation(s) and complications). Patients will be followed up at 4weeks, 3, 6, 12 and 24 months to assess to adequate bony union (through CT and clinical exam) as well as completed surveys of their experience and physical, mental, emotional and social outcomes.