IMPRESSeD: IMproving facial PRosthesis construction with contactlESs Scanning and Digital workflow
Not Applicable
- Conditions
- Facial defect following surgery for head or neck cancer. The trial management group may also widen participation to participants with facial trauma.CancerMalignant neoplasm of head, face, and neck
- Registration Number
- ISRCTN10516986
- Lead Sponsor
- niversity of Leeds
- Brief Summary
2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/37400919/ (added 04/07/2023)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 30
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 1. Eligibility rate measured as the proportion of people that were approached who were eligible for participation at baseline<br> 2. Recruitment rate measured as the proportion of people that were invited that were successfully recruited at baseline<br> 3. Conversion rate measured as the proportion of those who were eligible that consented to participate at baseline<br> 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<br>
- Secondary Outcome Measures
Name Time Method