Pilot Feasibility Study of Peristomal Adhesives

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

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.

Study Overview

• Status: Completed
• Conditions: Laryngectomy; Status
• Intervention / Treatment: Other: Moldable adhesive

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy, 00168
    • Fondazione Policlinico Universitario A. Gemelli - IRCCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laryngectomized patients	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigation about product performance	Adhesive lifetime during hands-free speech use [hours]	2 weeks
Investigation about product performance	Use of hands-free speech [days/week]	2 weeks
Investigation about product performance	Duration of hands-free speech [hours/day]	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parameters were expected to influence product performance and patient preference	Satisfaction (scored on a 5-point Likert scale)	2 weeks
Parameters were expected to influence product performance and patient preference	Adhesives fit (scored on a 5-point Likert scale)	2 weeks
Parameters were expected to influence product performance and patient preference	Adhesives usability (scored on a 5-point Likert scale),	2 weeks

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Claudio Parrilla, MD, PhD, Fondazione Policlinico Gemelli - IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): December 27, 2022

Study Registration Dates

• First Submitted: February 17, 2023
• First Submitted That Met QC Criteria: February 28, 2023
• First Posted (Estimate): March 9, 2023

Study Record Updates

• Last Update Posted (Estimate): March 9, 2023
• Last Update Submitted That Met QC Criteria: February 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 4650

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No