The novel mouldable peristomal adhesive (Provox Life FreeHands Adhesive) can be modelled to the patient*s neck and stoma shape when warmed, and remains its shape when cooled. The hypothesis is that this mouldable peristomal adhesive will improve the…
ID
Source
Brief title
Condition
- Head and neck therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of this study is to investigate the product performance
of Provox Life FreeHands Adhesive in combination with hands-free speech, in
subjects with a total laryngectomy, with the use of a study specific structured
questionnaire. Product performance is defined as the individual fit,
experienced comfort, user-friendliness, usability, and reasons for
non-compliant use (device or non-device related).
Secondary outcome
The secondary objective is to evaluate the device lifetime during hands-free
speech and duration of hands-free speech compared to their standard peristomal
adhesive (difference in [hours] or [hours/day], per subject) and the
self-assessed subject satisfaction of Provox Life FreeHands Adhesive with the
use of two study specific structured questionnaire.
Background summary
One of the consequences of a total laryngectomy (TL) is a complete
disconnection of the upper and lower airways. After TL, the patient is
breathing through a permanent tracheostoma in the neck. To aid pulmonary
rehabilitation, patients use a heat-moisture exchanger (HME). The HME can be
fixated in front of the tracheostoma opening with either a peristomal adhesive
or intratracheal tube or button. An automatic speaking valve (ASV) in
combination with an HME allows hands-free speech and removes the need to
occlude the stoma with the finger. Hands-free speech does exercise more stress
on the fixation product, which can lead to the loosening of the fixation
product or leakage of air. The novel mouldable peristomal adhesive (Provox Life
FreeHands Adhesive) can be modelled to the patient*s neck and stoma shape when
warmed, and remains its shape when cooled. The hypothesis is that this
mouldable peristomal adhesive will improve the individual fit and duration of
fixation during hands-free speech, which can result in a better overall product
performance during hands-free speech and self-assessed subject satisfaction
(preference and acceptance) compared to the standard peristomal adhesive
Study objective
The novel mouldable peristomal adhesive (Provox Life FreeHands Adhesive) can be
modelled to the patient*s neck and stoma shape when warmed, and remains its
shape when cooled. The hypothesis is that this mouldable peristomal adhesive
will improve the individual fit and duration of fixation during hands-free
speech, which can result in a better overall product performance during
hands-free speech and self-assessed subject satisfaction (preference and
acceptance) compared to the standard peristomal adhesive
Study design
prospective monocentre feasibility study
Intervention
All subjects are asked to use the mouldable peristomal adhesive (Provox Life
FreeHands Adhesive) for two consecutive weeks in combination with their normal
routine for application and removal of the adhesives and HME, and speech
rehabilitation.
Study burden and risks
No new risks have been identified related to the use of Provox Life Freehands
Adhesive.
A one-time visit is required at the start of the study to collect the baseline
data and to provide the study materials. This visit will take approximately 45
minutes
plesmanlaan 121
Amsterdam 1051 BT
NL
plesmanlaan 121
Amsterdam 1051 BT
NL
Listed location countries
Age
Inclusion criteria
- Total laryngectomized patient
- 18 years or older
- Voice prosthesis users
- Regular hands-free speech users: ASV with integrated HME
- Peristomal adhesive users (StabiliBase, XtraBase, FlexiDerm)
- Longer than 3 months after total laryngectomy
- Longer than 6 weeks after postoperative radiotherapy
Exclusion criteria
- LaryTube or LaryButton users
- Medical problems prohibiting the use of HME, ASV and/or adhesives
- Active recurrent or metastatic disease
- Reduced mobility of arms and/or hands
- Unable to understand patient information and/or to give informed consent
- Insufficient cognitive ability to handle the HME, ASV or mouldable adhesive
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL70725.031.19 |