Title: IMPRESSeD: IMproving facial PRosthesis construction with contactlESs Scanning and Digital workflow. A feasibility cross-over randomised controlled trial of digital versus conventional manufacture for facial prostheses in patients post-surgery for head and neck cancer.
Funder: Department of Health and Social Care

Abstract: Question:Is it feasible and potentially cost-effective to manufacture facial prostheses digitally for patients post-surgery for head and neck cancer (HNC)? Do patients report benefits versus conventionally manufactured prostheses and what are the cost consequences to the NHS? Background: Surgical management of HNC may remove a facial part with significant long-lasting impact on quality of life through deformity/functional impairment. Typically, facial defects are rehabilitated with removable prostheses. Over 2000 prostheses are made annually in the UK and replaced 6-18-monthly. Conventional manufacturing is time-consuming, labour-intensive and technically challenging. Our patient and public involvement (PPI) contributors co-produced three priority research areas: 1) elimination of uncomfortable/claustrophobic facial impressions, 2) improving aesthetic outcomes to restore their face closer to pre-surgery appearance, 3) improving rehabilitation efficiency avoiding several month delays for their first prosthesis.Digital workflows could address this significant health problem. Firstly, 3D facial scanning could offer contactless, comfortable and accurate data acquisition. Secondly, leading-edge 3D face tracking and reconstruction technology could provide personalised medicine through semi-automated prosthesis design based on photographs. Lastly, 3D printing moulds for producing prostheses could reduce the time and stages taken. Aim:To improve facial prosthesis construction using a leading-edge MedTech digital manufacturing workflow. Objectives: Evaluate literature regarding clinical, patient-centred and economic outcomes of facial prosthesis manufacture. Assess accuracy and repeatability of digital manufacturing workflow (comprising 3D facial scanning, semi-automated design and 3D printing wax patterns/resin moulds) for facial prosthesis construction. Undertake feasibility cross-over RCT to plan definitive trial. Evaluate main drivers for cost-effectiveness through early-stage health economic modelling and value of information assessment.Methods/Timeline [Month(M)]: Stage 1:-M-4-M4:-Systematic review of facial prosthesis manufacture. Stage 2:-M5-M11:-Pre-clinical evaluation. Scan 10 individuals with non-resected faces with commercial optical scanner. Manipulate 3D meshes to represent different types/severities of facial defects. Print physical model in resin. Undertake semi-automated design for hypothetical facial prostheses using photographs and 3D Morphable Model. Produce wax pattern/resin mould for prosthesis manufacture. Evaluate surface deviation to determine accuracy/repeatability of each stage. Stage 3:-M11-M33:-Feasibility cross-over RCT. Recruit 30 patients with facial defects and randomise 1:1 on order of receiving prostheses made by digital manufacturing (intervention) or conventional manufacturing (control). Following 1-month follow-up, patients receive second prosthesis from alternative manufacturing method. Feasibility outcomes: number of eligible patients, recruitment and attrition rates, acceptability of study design, consistency of outcome measures, fidelity of blinding, timing of cross-over and variance outcome data. Proposed outcomes for main trial: patient preference, health related QoL, patient satisfaction, costs from healthcare perspective and complications. Early health technology assessment through development of early-stage health economic model and value of information. Write-up:-M33-M36. Dissemination/Impact: This research addresses patients' three priority issues. It has potential for a step change in the manufacturing of facial prostheses through a personalised digital approach. It will provide information key to planning a definitive clinical effectiveness trial and assess main drivers for cost-effectiveness. Results will be shared through a stakeholder dissemination event, publications, national/international presentations and software for semi-automated design will be available online. PPI contributors will be engaged throughout. Participants/stakeholders will be updated of findings.

Lay abstract: Jargon-buster: Facial prosthesis =bespoke removable facial part. Impression =mould of a patient's face traditionally used to make facial prostheses. Facial scanning =using images or scans to gather information on the shape of a patient's face. 3D printing =using computers to help design and make facial prostheses.Background:Head and neck cancer has a major impact on patients' health and wellbeing. There are over 12,000 new cases each year in the UK. Half these patients have major surgery and some have a facial part removed e.g. an eye or nose. This affects how a patient looks, functions and impacts on their wellbeing. The missing facial part can be replaced with a removable facial prosthesis. At least 2,000 prostheses are made yearly in the UK. Patients need to attend multiple hospital visits so that highly trained healthcare staff can recreate the missing part. There is an ongoing burden to patients and healthcare services as prostheses are replaced every 6-18 months. Current methods of making prostheses have significant drawbacks. Our patient and public involvement (PPI) contributors selected three priority areas to improve: 1) To get rid of uncomfortable/painful facial impressions describing this as the worst part of having a prosthesis made. 2) To more closely match the way they looked before surgery. 3) To get their prosthesis sooner after surgery as prostheses help patients come to terms with surviving cancer. These areas link closely with the 'top 10 research priorities in head and neck cancer'. Digital technology could address this significant health problem and change the way prostheses are made. 1) Facial scanning could offer a contactless and comfortable alternative to impressions. 2) Prostheses can be designed using computers and photographs to better recreate the missing part. 3) The process for making prostheses can be made quicker by 3D printing moulds for the prostheses. Aim: To improve how facial prostheses are made using digital technology. Design/Methods: Stage-1: will review past research to find how other researchers have measured the success, costs and benefits of making facial prostheses. Stage-2: will develop a workflow for making facial prostheses and explore how accurately we can digitally design and make facial prostheses with computers and photographs. Stage-3: will provide evidence to support a larger study that will compare patient preference, costs and benefits of two ways of making prostheses. 30 patients will receive two new prostheses (one made digitally and the other made by usual practice). Patients and researchers will not know how the prostheses were made. Patients will be asked which prosthesis they prefer in terms of appearance, comfort and fit. Information will be collected on costs and benefits through surveys. It will consider whether there is enough evidence to use the digital technology in the NHS or whether larger studies are required. PPI: Patients have worked in partnership to ensure this research addresses their priorities for improvement: 1) pain/discomfort during the making of the prosthesis 2) achieving an appearance closer to their pre-surgical face and 3) speeding-up supply. PPI contributors have provided great insight into the lived experience and Suzie and Brian will continue to give advice to ensure the study brings the most patient benefit.Dissemination: This project will test if we can use digital technology to make facial prostheses and see if patients report benefits over those made by usual methods. This will give us confidence to go onto a main trial looking at the impact of digital technology in making prostheses in terms of patient benefits (patient preferences and quality of life) and NHS benefits (value for money). Participants, patients, healthcare workers and researchers will be updated on study findings.

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: CANCER AND NEOPLASMS;GENERIC HEALTH RELEVANCE