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Completed

NCT Number: NCT05762497

Pilot Feasibility Study of Peristomal Adhesives

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.

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Key information

Conditions

Laryngectomy; Status

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitario A. Gemelli - IRCCS

Roma, 00168, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Investigation about product performance

    Time frame: 2 weeks

    Adhesive lifetime during hands-free speech use [hours]

  2. Investigation about product performance

    Time frame: 2 weeks

    Use of hands-free speech [days/week]

  3. Investigation about product performance

    Time frame: 2 weeks

    Duration of hands-free speech [hours/day]

Secondary outcomes

  1. Parameters were expected to influence product performance and patient preference

    Time frame: 2 weeks

    Satisfaction (scored on a 5-point Likert scale)

  2. Parameters were expected to influence product performance and patient preference

    Time frame: 2 weeks

    Adhesives fit (scored on a 5-point Likert scale)

  3. Parameters were expected to influence product performance and patient preference

    Time frame: 2 weeks

    Adhesives usability (scored on a 5-point Likert scale),

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 9, 2023
Registry last updated
Mar 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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