Laryngectomy; Status
Conditions
Brief summary
Loss of voice is one of the greater consequences of total laryngectomy. The voice prosthesis allows the patients to speak again in a very short time but forces them to use one hand when speaking. In order to reduce this discomfort and to allow hands-free speaking, an Automatic Speaking Valve (ASV) has been designed which is positioned on a peristomal adhesive. Peristomal adhesives, however, tend to detach under the influence of mucus, cough, or phonatory pressure. Consequently, the current regular use of the automatic speaking valve in laryngectomees is very low. As a possible solution, Atos Medical AB has developed a moldable peristomal adhesive made of a thermoplastic elastomer, which becomes transparent and moldable when heated and facilitates precise contouring in situ. As the material cools, it loses its malleability but retains the integrity of the molded shape. The expectation was that the moldable adhesive would provide a better individual fit and therefore longer fixation (especially when using the ASV). To study the feasibility of this device, 10 total laryngectomized patients were asked to use the new moldable peristomal adhesive for two weeks in conjunction with their normal daily routine for adhesive application and removal, and speech rehabilitation.
Interventions
OTHERMoldable adhesive
Patients were provided with the new adhesives and a short questionnaire on current ASV use. After a week, they were contacted by telephone to verify any doubts/problems. At the end of the two weeks, the patient was again administered a questionnaire to evaluate the new moldable adhesive (while using the ASV).
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Have undergone total laryngectomy * Over the age of 18 * voice prosthesis user * Experience in the use of adhesive and HMEs * At least 3 months after total laryngectomy * At least 6 months after the end of adjuvant radiotherapy * Signature of the informed consent
Exclusion criteria
* Medical issues that prevent the use of HMEs and/or adhesives * Recurrent or metastatic active disease * Reduced mobility of the arms and/or hands * Inability to understand the information and/or to provide informed consent * Insufficient cognitive ability to handle HME or moldable adhesive
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigation about product performance | 2 weeks | Adhesive lifetime during hands-free speech use \[hours\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parameters were expected to influence product performance and patient preference | 2 weeks | Satisfaction (scored on a 5-point Likert scale) |
Countries
Italy
Outcome results
None listed