NCT05762497

Pilot Feasibility Study of Peristomal Adhesives

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Laryngectomy; Status

Interventions

Type	Name	Description
OTHER	Moldable 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).

Timeline

• Start date: 2022-07-01
• Primary completion: 2022-09-01
• Completion: 2022-12-27
• First posted: 2023-03-09
• Last updated: 2023-03-09

Locations

1 site across 1 country: Italy