Pilot Feasibility Study of Peristomal Adhesives

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.

Inclusion Criteria:Have undergone total laryngectomyOver the age of 18voice prosthesis userExperience in the use of adhesive and HMEsAt least 3 months after total laryngectomyAt least 6 months after the end of adjuvant radiotherapySignature of the informed consentExclusion Criteria:Medical issues that prevent the use of HMEs and/or adhesivesRecurrent or metastatic active diseaseReduced mobility of the arms and/or handsInability to understand the information and/or to provide informed consentInsufficient cognitive ability to handle HME or moldable adhesive