laryngectomy removal of larynx
Conditions
Interventions
All subjects are asked to use the mouldable peristomal adhesive (Provox Life
FreeHands Adhesive) for two consecutive weeks in combination with their normal
routine for application and removal of the
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Total laryngectomized patient - 18 years or older - Voice prosthesis users - Regular hands-free speech users: ASV with integrated HME - Peristomal adhesive users (StabiliBase, XtraBase, FlexiDerm) - Longer than 3 months after total laryngectomy - Longer than 6 weeks after postoperative radiotherapy
Exclusion criteria
Exclusion criteria: - LaryTube or LaryButton users - Medical problems prohibiting the use of HME, ASV and/or adhesives - Active recurrent or metastatic disease - Reduced mobility of arms and/or hands - Unable to understand patient information and/or to give informed consent - Insufficient cognitive ability to handle the HME, ASV or mouldable adhesive
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to investigate the product performance of Provox Life FreeHands Adhesive in combination with hands-free speech, in subjects with a total laryngectomy, with the use of a study specific structured questionnaire. Product performance is defined as the individual fit, experienced comfort, user-friendliness, usability, and reasons for non-compliant use (device or non-device related). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective is to evaluate the device lifetime during hands-free speech and duration of hands-free speech compared to their standard peristomal adhesive (difference in [hours] or [hours/day], per subject) and the self-assessed subject satisfaction of Provox Life FreeHands Adhesive with the use of two study specific structured questionnaire. | — |
Countries
Netherlands
Outcome results
None listed