IMPRESSeD (V1.0)
Research type
Research Study
Full 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.
IRAS ID
283502
Contact name
Rachael Y Jablonski
Contact email
Sponsor organisation
University of Leeds
ISRCTN Number
ISRCTN10516986
Clinicaltrials.gov Identifier
ULXXO.A200515, Leeds Cares Funding (now known as Leeds Hospitals Charity from Jan 2021); To apply once registered on CPMS system, ISRCTN
Duration of Study in the UK
2 years, 1 months, 29 days
Research summary
Research Summary:
Some people may be missing a facial part e.g. an eye or nose. This can be due to a number of reasons including trauma or surgery for head and neck cancer. This affects a patient’s appearance, function and wellbeing. The missing part can be replaced with a bespoke removable silicone facial prosthesis. Patients attend multiple hospital visits so that highly trained healthcare staff can recreate the missing part. There is an ongoing patient and healthcare burden as prostheses are replaced every 6-24 months.
The current standard of making facial prostheses has significant drawbacks. Our patient and public involvement contributors selected three priority improvement areas: 1) get rid of uncomfortable/painful facial moulds (impressions) used to make prostheses, 2) more closely match the way they looked before surgery, and 3) receive their prosthesis sooner after surgery.
Digital technology could change the way prostheses are made: 1) facial scanning could offer a contactless and comfortable alternative to impressions, 2) prostheses could be designed using computers to recreate the missing part, and 3) the process could be made quicker using 3D printing technology.
This feasibility study aims to assess the possibility of conducting a future full-scale trial that will compare patient preference, costs and benefits of using digital technology to make facial prostheses compared with current standard of care.
We will recruit up to 30 adult patients across two NHS hospitals who require a replacement eye or nose facial prosthesis. Each patient will receive two new prostheses which will be made at the same time (one made digitally and one made by current standards). Patients will not know how each prosthesis was made. Patients will be reviewed four weeks after receiving each prosthesis. They will be asked which prosthesis they prefer. Information will be collected on costs and benefits through surveys.
Summary of results:
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 prosthesesWho carried out the research?
The Sponsor for the study was the University of Leeds. Rachael Jablonski, NIHR Doctoral Fellow, NIHR300235 was funded by the National Institute for Health and Care Research (NIHR) for this research project. The research was supported by the NIHR infrastructure at Leeds and also by Leeds Hospitals Charity [Funding for Research and Innovation, Rachael Jablonski, ULXXO/A200515]. The views expressed in this summary of results are those of the authors and not necessarily those of the NIHR, NHS, other funders or the UK Department of Health and Social Care. The funding sources had no influence in the conduct of the study, writing of the report, or the decision to submit the work for publication.What public involvement was there in the study?
Two key groups of Patient and Public Involvement (PPI) contributors have been central to all key stages of the IMPRESSeD study. First, a specialist group of PPI contributors brought the lived experience of facial prostheses to the research project. Second, an established group of PPI contributors (SMILE-AIDER; Stakeholder Meaningful InvoLvement and Engagement AIding DEntal Research) brought a more general societal perspective.
When starting to develop research ideas, Suzie and Brian offered valuable contributions by helping prioritise research needs, co-designing the research study, and informing the funding applications. During IMPRESSeD, Robin and Peter were important members of the study’s independent advisory committee who ensured the project remained patient centred. For public engagement, Rebecca, Robin and Peter co-created I’m Still Me and helped consider important messages for a meaningful connection with the wider community. The SMILE AIDER PPIE forum were particularly supportive of the narratives being placed alongside the portraits, believing that this helped bring the patient stories of their rehabilitation to life. They advised that the narrative content was both impactful and appropriate but also very powerful.Where and when the study took place?
The study was undertaken at Leeds Teaching Hospitals NHS Trust and Guy’s and St Thomas’ NHS Foundation Trust. The study start date was 1 December 2021 and the study end date was 11 October 2023.Why was the research needed?
Some people may be missing a facial part e.g. an eye or nose. This can be due to various reasons including trauma or surgery for head and neck cancer. This affects a patient’s appearance, function and wellbeing. The missing part can be replaced with a bespoke removable silicone facial prosthesis created during multiple hospital visits. There is an ongoing patient and healthcare burden as prostheses are replaced every 6-24 months.
The current standard way of making facial prostheses has drawbacks. Our PPI involvement contributors selected three priority improvement areas to improve: 1) remove the reliance on uncomfortable facial moulds (impressions) used to make prostheses, 2) more closely match the way they looked before surgery, and 3) receive their prosthesis sooner after surgery.
Digital technology could change the way prostheses are made: 1) facial scanning could offer a contactless alternative to impressions, 2) prostheses could be designed using computers to recreate the missing part, and 3) the process could be made quicker using 3D printing technology.What were the main questions studied?
This study assessed whether it would be possible to conduct a future full-scale trial that would compare patient preference, costs and benefits of using digital technology to make facial prostheses compared with the current standard way of making facial prostheses.Who took part in the study?
Fifteen adult patients who required a replacement eye, nose or combined facial prosthesis took part across two NHS hospitals.
What treatments did the patients receive?
The standard way of making a facial prosthesis is entirely by hand. This involved:
● taking a mould (i.e. impression) of a patient’s face
● making the eye component if required
● hand crafting a wax version of the prosthesis and testing it
● choosing the colours for the prosthesis
● fitting the prosthesis
The other way of making facial prostheses involves using digital technology. This involved:
● taking a scan of a patient’s face
● making the eye component if required
● using computers to help design and produce the wax version of the prosthesis and testing it
● choosing the colours for the prosthesis
● fitting the prosthesisWhat happened during the study?
Each patient was provided with two new prostheses. One was made entirely by hand and the other was made using digital technology. Patients were given one prosthesis followed by the other in a random order. Patients were not told how each prosthesis was made. Patients were reviewed four weeks after receiving each prosthesis. They were asked which prosthesis they preferred. Information was collected on costs and benefits through surveys. Patients were also invited to take part in an interview which explored patients’ perception, lived experience, and preference of the two methods of making facial prostheses.What were the results of the study?
Out of the 17 patients who were invited, 15 took part in the study (88%). Four out of the 15 patients did not complete the study (27%). Reasons for not completing the study included ill health (3 patients) and availability (1 patient).
When asked which prosthesis they preferred, 45% of patients chose the prostheses made using digital technology, 27% chose the prosthesis made entirely by hand, and the rest had no preference (they liked both the same).
The survey results showed an improvement in patients’ quality of life after being provided with the new prostheses. There were small differences in the survey results between the prosthesis made using digital technology and the prosthesis made entirely by hand.
The average amount of time spent by staff members was 10 hours for the prosthesis made using digital technology and 9 hours for the prosthesis made entirely by hand. The longer times using the digital technology were likely due to the staff getting used to using the new technology; we anticipate this would reduce over time as they become more familiar with the technology. The average equipment time was 50 hours for the prosthesis made using digital technology and 12 hours for the prosthesis made entirely by hand. The average total costs for making the prostheses were similar at £1017 for the prosthesis made using digital technology and £1065 for the prosthesis made entirely by hand.
Ten patients took part in the qualitative sub-study and most (90%) preferred the processes involved with making a prosthesis using digital technologies.What medical problems (adverse events) did the patients have?
Fifteen adverse events occurred that were unrelated to study treatment such as infections or illnesses. Two adverse reactions occurred that were related to the prostheses made using digital technology. One patient reported scratching their cheek when removing their prosthesis and another had symptoms of a fungal infection; both resolved with self-care advice.
How has this study helped patients and researchers?
The digital manufacture of facial prostheses has the potential to offer patient and healthcare benefits through improved outcomes, patient experience, and use of resources. The technology needs to be appropriately tested and this small study is the first step toward designing a large trial comparing the costs and benefits of the two ways of making facial prostheses. A large trial would be feasible, worthwhile, and safe to deliver though some small changes to study design have also been suggested.Is any further research planned?
First, an in depth analysis of the interviews should explore patients’ thoughts, experiences and preferences of the two ways of having a prosthesis made. Second, an analysis of the potential cost effectiveness (costs and benefits) of using digital technology to make facial prostheses should be completed.
In addition, the research findings will be shared with the wider public through an art-science public engagement project. “I’m Still Me” has been co-produced by PPI contributors, healthcare staff, researchers, artists, and public engagement staff. This work will share the lived experience of people who wear facial prostheses, bring research findings out into the wider community, and highlight the valuable role of patients and PPI contributors in research and public engagement.Where can I learn more about this study?
● You can learn more about the study here: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fmedicinehealth.leeds.ac.uk%252Fdir-record%252Fresearch-projects%252F1835%252Fthe-impressed-study%2FNBTI%2FMoW4AQ%2FAQ%2F96e1d470-0680-42f2-a501-ad81ce38b547%2F2%2F3KQGWc8yU2&data=05%7C02%7Cleedseast.rec%40hra.nhs.uk%7Cbda4fb0487f546b8522808dce6d545d2%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638639050915905882%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=iwz%2Bg2OIKBjJYVLG2qVbrN%2BFX7hhrELiJ3Z5Yq0ShQM%3D&reserved=0
● You can learn more about the art-science project here: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fleeds.ac.uk%252Fim-still-me%2FNBTI%2FMoW4AQ%2FAQ%2F96e1d470-0680-42f2-a501-ad81ce38b547%2F3%2FGH2NqRua1q&data=05%7C02%7Cleedseast.rec%40hra.nhs.uk%7Cbda4fb0487f546b8522808dce6d545d2%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638639050915919173%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=qwglrQm1bS6q7eDDiUjfSnb0Hblfrh%2Bu83DMVg7gQmY%3D&reserved=0
https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fdoi.org%252F10.1186%252FISRCTN10516986%2FNBTI%2FMoW4AQ%2FAQ%2F96e1d470-0680-42f2-a501-ad81ce38b547%2F4%2FHwPVP-5w44&data=05%7C02%7Cleedseast.rec%40hra.nhs.uk%7Cbda4fb0487f546b8522808dce6d545d2%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638639050915932677%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=EF%2Bqoa9VzXIlixmDR%2BdYe0TKCC0pdRgmvnjyMnmIyts%3D&reserved=0REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
21/YH/0028
Date of REC Opinion
8 Feb 2021
REC opinion
Favourable Opinion