IMproving facial PRosthesis construction with contactlESs Scanning and Digital workflow (IMPRESSeD). Study protocol for a feasibility crossover randomised controlled trial of digital versus conventional manufacture of facial prostheses in patients with orbital or nasal facial defects

Facial prostheses can have a profound impact on patients’ appearance, function and quality of life. There has been increasing interest in the digital manufacturing of facial prostheses which may offer many benefits to patients and healthcare services compared with conventional manufacturing processes. Most facial prosthesis research has adopted observational study designs with very few randomised controlled trials (RCTs) documented. There is a clear need for a well-designed RCT to compare the clinical and cost-effectiveness of digitally manufactured facial prostheses versus conventionally manufactured facial prostheses. This study protocol describes the planned conduct of a feasibility RCT which aims to address this knowledge gap and determine whether it is feasible to conduct a future definitive RCT.