Pilot Feasibility Study of Peristomal Adhesives

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Feasibility Study of a Moldable Peristomal Adhesive for Pulmonary and Speech Rehabilitation After Total Laryngectomy

Conditions
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Laryngectomy; Status

Intervention / Treatment
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* Other: Moldable adhesive


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laryngectomized patients<br> | Other: Moldable adhesive<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigation about product performance | Adhesive lifetime during hands-free speech use [hours] | 2 weeks | 
| Investigation about product performance | Use of hands-free speech [days/week] | 2 weeks | 
| Investigation about product performance | Duration of hands-free speech [hours/day] | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parameters were expected to influence product performance and patient preference | Satisfaction (scored on a 5-point Likert scale) | 2 weeks | 
| Parameters were expected to influence product performance and patient preference | Adhesives fit (scored on a 5-point Likert scale) | 2 weeks | 
| Parameters were expected to influence product performance and patient preference | Adhesives usability (scored on a 5-point Likert scale), | 2 weeks |