Facial defect following surgery for head or neck cancer. The trial management group may also widen participation to participants with facial trauma. Cancer Malignant neoplasm of head, face, and neck
Conditions
Interventions
The intervention is a facial prosthesis produced through digital manufacturing. The manufacturing process will involve 3D facial scanning, computer aided design, and computer aided manufacturing. The
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Acquired orbital or nasal facial defects 2. Require a replacement orbital or nasal facial prosthesis 3. Capable of giving informed consent 4. Available for follow-up 5. Aged =16 years
Exclusion criteria
Exclusion criteria: 1. Receiving active cancer therapy or have plans for major reconstructive surgery 2. Have not received a removable facial prosthesis previously 3. Facial defects due to an underlying congenital aetiology 4. Known hypersensitivity to the materials used in the research 5. Pre-existing skin conditions that require intervention and prevent the delivery of a new prosthesis 6. Unable to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Eligibility rate measured as the proportion of people that were approached who were eligible for participation at baseline 2. Recruitment rate measured as the proportion of people that were invited that were successfully recruited at baseline 3. Conversion rate measured as the proportion of those who were eligible that consented to participate at baseline 4. Attrition rate measured as the proportion of those that dropped out of the trial at 4-week review following delivery of the second prosthesis | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 23/06/2022: 1. Participant preference measured using a question at the final review visit (4-week review following delivery of the second prosthesis) 2. Condition-specific quality of life measured using the Toronto Outcome Measure for Craniofacial Prosthetics (TOMCP-27) at baseline, 4-week review following delivery of the first prosthesis, and 4-week review following delivery of the second prosthesis 3. Quality of life measured using the Short Form 12 item version 2 (SF-12v2) and EQ-5D-5L at baseline, 4-week review following delivery of the first prosthesis, and 4-week review following delivery of the second prosthesis 4. Resource use measured using questionnaires during all clinical visits and laboratory stages 5. Qualitative substudy (semi-structured interviews) Previous secondary outcome measures: 1. Participant preference measured using a question at the final review visit (4-week review following delivery of the second prosthesis) 2. Condition-specific quality of life measured using the Toronto Outcome Measure for Craniofacial Prosthetics (TOMCP-27) at baseline, 4-week review following delivery of the first prosthesis, and 4-week review following delivery of the second prosthesis 3. Quality of life measured using the Short Form 12 item version 2 (SF-12v2) at baseline, 4-week review following delivery of the first prosthesis, and 4-week review following delivery of the second prosthesis 4. Resource use measured using questionnaires during all clinical visits and laboratory stages | — |
Countries
England, United Kingdom
Outcome results
None listed