Pilot Feasibility Study of Peristomal Adhesives

Laryngectomy; Status Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05762497
• Other study ID #: 4650
• Status: Completed
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: December 27, 2022

Study information

• Verified date: February 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 27, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Laryngectomy; Status

Intervention

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).

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario A. Gemelli - IRCCS	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigation about product performance	Adhesive lifetime during hands-free speech use [hours]	2 weeks
Primary	Investigation about product performance	Use of hands-free speech [days/week]	2 weeks
Primary	Investigation about product performance	Duration of hands-free speech [hours/day]	2 weeks
Secondary	Parameters were expected to influence product performance and patient preference	Satisfaction (scored on a 5-point Likert scale)	2 weeks
Secondary	Parameters were expected to influence product performance and patient preference	Adhesives fit (scored on a 5-point Likert scale)	2 weeks
Secondary	Parameters were expected to influence product performance and patient preference	Adhesives usability (scored on a 5-point Likert scale),	2 weeks