Clinical assessment of a new adhesive and HME for night-time use in laryngectomized patients: Provox Luna

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. Laryngectomized
patients use a variety of devices in front of the tracheostoma: Heat and
Moisture Exchangers (HMEs) to condition the inhaled air, hands free 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. A
variety of attachment methods is available, such as adhesives in different
types, designs and shapes. However, feedback from clinicians and patients has
revealed that some patients experience skin irritation when using certain
adhesives. In literature skin irritation is reported on average in about 20% of
the laryngectomized patients, with a range from 9% to 40%1-7. A large survey
(n=729) performed by Atos Medical (2015) showed that 47% of the patients
sometimes experience skin irritation and lets the skin rest by not using an
adhesive for a period of time. This number is higher than the 20% reported in
the literature. However, skin irritation was not usually an outcome measure in
these studies, but mostly reported as a negative effect (adverse effect) of the
adhesives used in the studies. In the survey patients were specifically asked
questions concerning skin irritation. This could explain the difference in
reported percentage between literature and the survey, where we believe the 47%
of the survey is probably more representative than the average percentage of
20% mentioned in literature.

The survey shows that on average the patients let their skin rest 2.2 days per
week, and mostly during the night. During skin rest the patients do not use any
adhesives, and consequently the assumption is that they do not use an HME. The
high percentage in this survey shows the importance of an adhesive that has the
potential to decrease skin irritation and therefore to potentially increase
compliant use of HMEs. Furthermore, feedback from patients revealed that
wearing an adhesive with HME during night-time is sometimes considered
uncomfortable. Instead, patients use alternatives, such as bibs and scarves, or
nothing at all. Therefore, compliant HME use (24/7) is not achieved by all
patients, which has a negative effect on pulmonary rehabilitation. Hence, a new
default solution for night-time use is developed, Provox Luna.

Provox Luna consists of an adhesive and an HME. Provox Luna Adhesive is a new
adhesive, made of a hydrogel material. Hydrogels are commonly used on a wide
variety of wounds, such as skin tears, pressure ulcers, burn wounds and
surgical wounds. Hydrogel dressings are water- or glycerin-based products, best
suited for dry wounds or those with minimal to moderate exudates8, 9. Hydrogel
sheet dressings are reported to be comfortable and soothing, and to reduce pain
because of their cooling effect10-14. Although the use of hydrogel has been
widely described in the medical literature, hydrogel adhesives have so far not
been used for the stoma area of laryngectomized patients.


Provox Luna HME is a soft silicone HME with a pressure drop of 55Pa at 30L/min
and a moisture loss of 21.4mgH2O/L air. With these values, the humidification
properties of the Provox Luna HME are the same as for the Provox XtraMoist,
whereas the pressure drop and hence the breathing resistance, is lower than for
the Provox XtraMoist (with a pressure drop of 70Pa) and slightly higher than
that of the Provox XtraFlow (with a pressure drop of 40Pa). These properties
are intended to enhance comfort during sleep. Silicone is widely used in
products for laryngectomized patients, but has so far not been used as material
for HMEs.

The current available adhesives and HMEs are focused primarily on daytime use
and speaking. Provox Luna is intended as a night time solution for
laryngectomized patients and is expected to reduce or avoid skin irritation and
increase comfort. This is expected to lead to increased compliant HME use,
thereby optimizing pulmonary rehabilitation.

The objective of this clinical investigation is to evaluate the clinical
performance of Provox Luna in comparison to the usual care of the patient.

A multi-center time-series observational study with multiple measurements in
which the patients will act as their own control. The study will consist of two
periods of four weeks with multiple data collection points.

This study design is chosen in order to reduce bias. Use of the new Provox Luna
is expected to influence the behavior of the patient and thereby their answers
regarding usual care. The first period of 4 weeks with double baseline and
daily diary will give reliable and valid data concerning the usual behavior and
use of products, making it possible to compare their usual behavior to the
period when they use the Provox Luna in addition to their usual products.

The study will consist of two periods of four weeks with multiple data
collection points. In the first period of four weeks, patients will document
their usual use of attachments and HMEs. After these four weeks, the patients
will receive Provox Luna. In the second period of four weeks patients will be
asked to use Provox Luna as often as needed or wanted, but with a minimum of 8
nights, supplementary to their usual products. Data collection will take place
at zero and four weeks in the first period, and at four weeks in the second
period.

No risks have been identified related to Provox® Luna when used as intended.
It is expected that the study may be of some burden to some patients due to the
fact that the participants are required to keep a diary of their experiences
with Provox Luna and their usual care. However, the diaries have been kept as
short as possible. It could also be a burden for them if the products they are
asked to try out do not work well for them. Also the visits to the hospital can
be experienced as burdensome. Visits are required at the beginning of the study
to collect baseline data, after a month to collect usual care data and to
receive the devices, and after two months to collect Provox Luna data. These
visits will take about 45 minutes. The follow-ups by phone will all be short.