Pilot Feasibility Study of Peristomal Adhesives

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

Conditions: Laryngectomy; Status

Treatments: Other: Moldable adhesive

Study type: Interventional

Funder types: Other

Identifiers

NCT05762497

4650

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Laryngectomized patients

Experimental group

Treatment:

Other: Moldable adhesive