Clinical trial NCT05762497: Pilot Feasibility Study of Peristomal Adhesives
Official title: Pilot Feasibility Study of a Moldable Peristomal Adhesive for Pulmonary and Speech Rehabilitation After Total Laryngectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laryngectomy; Status
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Investigation about product performance
timeFrame: 2 weeks
measure: Investigation about product performance
timeFrame: 2 weeks
measure: Investigation about product performance
timeFrame: 2 weeks
Secondary outcomes:
measure: Parameters were expected to influence product performance and patient preference
timeFrame: 2 weeks
measure: Parameters were expected to influence product performance and patient preference
timeFrame: 2 weeks
measure: Parameters were expected to influence product performance and patient preference
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli - IRCCS
Study officials:
affiliation: Fondazione Policlinico Gemelli - IRCCS
name: Claudio Parrilla, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: