Pilot Feasibility Study of Peristomal Adhesives

Not Applicable

Completed

• Conditions: Laryngectomy; Status
• Interventions: Other: Moldable adhesive

• Registration Number: NCT05762497
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Primary Completion: 2022-09-01
• Study Completion: 2022-12-27
• Status Verified: 2023-02
• Study First Submitted: 2023-02-17
• Study First Submitted QC: 2023-02-28
• Last Update Submitted: 2023-02-28
• Study First Posted: 2023-03-09
• Last Update Posted: 2023-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Laryngectomized patients	Moldable adhesive	-

Primary Outcome Measures

Name	Time	Method
Investigation about product performance	2 weeks	Duration of hands-free speech \[hours/day\]

Secondary Outcome Measures

Name	Time	Method
Parameters were expected to influence product performance and patient preference	2 weeks	Adhesives usability (scored on a 5-point Likert scale),

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A. Gemelli - IRCCS; 🇮🇹 Roma, Italy