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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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).
Fondazione Policlinico Universitario A. Gemelli - IRCCS
Roma, Italy
Investigation about product performance
Adhesive lifetime during hands-free speech use \[hours\]
Time frame: 2 weeks
Investigation about product performance
Use of hands-free speech \[days/week\]
Time frame: 2 weeks
Investigation about product performance
Duration of hands-free speech \[hours/day\]
Time frame: 2 weeks
Parameters were expected to influence product performance and patient preference
Satisfaction (scored on a 5-point Likert scale)
Time frame: 2 weeks
Parameters were expected to influence product performance and patient preference
Adhesives fit (scored on a 5-point Likert scale)
Time frame: 2 weeks
Parameters were expected to influence product performance and patient preference
Adhesives usability (scored on a 5-point Likert scale),
Time frame: 2 weeks
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