Pilot Feasibility Study of Peristomal Adhesives

NCT ID: NCT05762497

Last Updated: 2023-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2022-12-27

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.

Conditions

Laryngectomy; Status

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laryngectomized patients

Group Type: EXPERIMENTAL

Moldable adhesive

Intervention Type: OTHER

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).

Interventions

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).

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Parrilla Claudio

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claudio Parrilla, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Gemelli - IRCCS

Locations

Fondazione Policlinico Universitario A. Gemelli - IRCCS

Roma, , Italy

Countries

Italy

Other Identifiers

4650

Identifier Type: -

Identifier Source: org_study_id