To investigate the clinical feasibility of the Provox StabiliBase adhesive.
ID
Source
Brief title
Condition
- Head and neck therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Patient preference
Secondary outcome
Device life of the adhesive
Patient satisfaction
Voice and Speech (perceptual evaluation, maximum phonation time, phrasing)
Ease of application
Background summary
One of the consequences of a total laryngectomy is a complete disconnection of
the upper and lower airways. After this type of surgery, the patient is
breathing through a permanent tracheostoma in the neck. Several appliances
(Heat and Moisture Exchangers (HMEs) to condition the inhaled air, handsfree
speaking valves to allow speaking without the need to occlude the stoma with a
finger, and shower aids to prevent water from entering the airways while
showering) are used in front of the tracheostoma. These appliances are held in
front of the stoma by means of adhesive base plates, laryngectomy tubes, or
tracheostoma buttons. Although a variety of adhesives exists, further
improvement is possible and desired.
The new Provox StabiliBase is has a more stable base than the current range of
adhesives, combined with a FlexiDerm plaster. The adhesive is expected to be a
better solution than the current adhesives for a proportion of the patients. In
those patients it is expected to last longer, fit better and perhaps lead to
better voice and speech and longer use of a handsfree speaking valve.
A user study is necessary to assess the clinical feasibility of this new
adhesive.
Study objective
To investigate the clinical feasibility of the Provox StabiliBase adhesive.
Study design
The study will be a non-randomized prospective controlled study in which the
patients will serve as their own controls. The study will consist of three
parts. All patients will participate in part 1 and 2, only patients wishing to
continue and (previously) using a handsfree speaking valve will participate in
part 3. The study is not randomized because that would eliminate the
possibility to collect useful baseline data.
Intervention
Application of an adhesive base plate to the peristomal skin.
Study burden and risks
No new risks have been identified related to this new adhesive.
It is expected that the study may be of some burden to some patients due to the
3 required visits in 5 weeks time and the request to keep a patient diary. The
patient information and informed consent procedure will take about 10 minutes.
Each visit is expected to take 45 minutes.
Kraftgatan 8
24222
Zweden
Kraftgatan 8
24222
Zweden
Listed location countries
Age
Inclusion criteria
laryngectomy
voice prosthesis user
HME user
Exclusion criteria
skin problems tracheostoma, allergy to adhesive
medical problems prohibiting HME use
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL31745.031.10 |