Pilot Feasibility Study of Peristomal Adhesives

NCT05762497 | Completed

• 1 other identifier: 4650
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Parameters were expected to influence product performance and patient preference

  2 weeks

• Parameters were expected to influence product performance and patient preference

  2 weeks

• Parameters were expected to influence product performance and patient preference

  2 weeks

Study Arms (1)

Laryngectomized patients

EXPERIMENTAL

Other: Moldable adhesive

Interventions

Moldable adhesive 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).

Laryngectomized patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli - IRCCS

Roma, 00168, Italy

Location

Study Officials

• Claudio Parrilla, MD, PhD

  Fondazione Policlinico Gemelli - IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: March 9, 2023
• Study Start: July 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: December 27, 2022
• Last Updated: March 9, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)