Usability of oat-coated gloves (intervention) and the effect on skin condition in comparison to non-coated gloves (care as usual).
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are the prospective analysis of skin condition of the
hands of the HCW and their user experience. The primary endpoint is the
difference in change in Osnabrück hand eczema severity index (OHSI), from
baseline to 6 months between HCW using the oat coated gloves (intervention
group ) and HCW using non-coated gloves ( care as usual group.
Secondary outcome
Secondary endpoints are the difference in patients reported outcomes (Quality
of Life in Hand Eczema Questionnaire (QLHEQ), user experience questionnaire-
short version (UEQ-S)) between groups. Furthermore differences in Trans
Epidermal Water Loss (TEWL), skin hydration, skin erythema and levels of
inflammatory cytokines and natural moisturizing factors (NMF) in tape strips
are measured between the intervention and control group.
Background summary
Hand eczema (HE) is the most common occupational skin disease. (1) In
particular employees in professions with frequent use of disposable gloves
suffer from work-related hand eczema. (2-4) As a consequence of the mandatory
frequent use of disposable gloves, 30 - 60% of nurses adhering to the hygiene
guidelines suffer from irritant contact dermatitis (ICD) of the hands. (5, 6)
This highlights the need for a disposable glove that is less skin-irritating
or, preferably, has skin condition-improving capacities to prevent occupational
HE.
Study objective
Usability of oat-coated gloves (intervention) and the effect on skin condition
in comparison to non-coated gloves (care as usual).
Study design
Single center, double-blind randomized controlled trial. Health care workers
(HCW) will be randomized to the intervention group (oat coated gloves) or the
care as usual group (non-coated gloves) for a period of six months. Because of
practical considerations HCW will be randomized by department in the
intervention or control group.
Intervention
HCW in the intervention arm will receive disposable nitrile examination gloves
with an oat coating and HCW in the care as usual arm will receive non coated
disposable nitrile gloves, as HCW currently use. The coating on the inner side
of the glove consist of colloidal oatmeal to protect the skin underneath the
glove. The oat coating is not visible and when taking off the glove no oat
residue remains on the skin. The HCW perform their regular daily work
activities.
Study burden and risks
The burden and health risk for the HCW associated with participation is
negligible. The oat coating is the only difference between the current
disposable examination gloves used in the hospital and the intervention gloves.
A potential risk is the development of an allergy to oats, which is extremely
rare. Patients known with an oat allergy will be excluded. Subjects perform
their regular daily work activities. To date, no allergic reactions to oat
coated gloves have been reported to Lareb and The Health and Youth Care
Inspectorate (IGJ). The skin condition of the hands of the participating HCW
will be examined by a physician at baseline and three times during the
treatment period of 6 months. Questionnaires about baseline characteristics,
quality of life (QoL) and user experience will be administered. Patient will
rate itch and pain on a numeric rating scale (NRS). Non-invasive assessments
including TEWL, skin hydration and skin erythema will be performed. Furthermore
tape strips will be taken from the skin of the hands from the HCW. This implies
that the stratum corneum, the uppermost dead layer of the skin will be
collected of the back of the hands using adhesive tapes, which is a minimally
invasive procedure. This procedure has often been applied in the studies of our
research group and elsewhere. Each visit will take approximately 15 minutes.
The measurements are taken at the HCW*s workplace for their convenience.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
healthcare workers with prolonged wearing of occlusive disposable gloves
Exclusion criteria
not using disposable gloves during work
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 | NL87482.018.24 |