Determination of the contribution of skin absorption relative to inhalation as the route of uptake of alcohol following topical application of ABHR for hygienic disinfection in a controlled laboratory setting to support an improved risk assessment
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Er wordt geen aandoening onderzocht omdat het om een kinetiek studie gaat
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Blood concentration of alcohol and alcohol-d6
- Exhaled air concentration of alcohol and alcohol-d6
Secondary outcome
- Amount of hand disinfection product applied
- Ethanol concentration in ambient air
- Room size and free air volume
- Air exchange rate of the room ventilation system
- Air concentration of ethanol
- Trans-epidermal water loss (TEWL), skin hydration and skin pH
- Chronic hand dermatitis according to severty scale Coenraads et al 2005
Background summary
The use of alcohol-based hand rubs (ABHR) for hygienic disinfection by
healthcare workers leads to uptake by inhalation and presumably also by skin
absorption. A safety evaluation addressing the risk of low exposures over a
long-term exposure is incomplete due to the lack of human data. We propose a
volunteer study in a controlled laboratory environment to study the kinetics of
the uptake of alcohol by inhalation and dermal absorption to support the
calibration of a physiology-based pharmacokinetic (PBK) model. This model will
then be used to support exposure assessment by human biomonitoring. Forthcoming
data will be used for the human risk assessment of professional ABHR practice.
Study objective
Determination of the contribution of skin absorption relative to inhalation as
the route of uptake of alcohol following topical application of ABHR for
hygienic disinfection in a controlled laboratory setting to support an improved
risk assessment
Study design
Intervention study using Steriliium med as a commonly used product for hygienic
disinfection with 85% alcohol in a controlled laboratory setting. This product
will be doped with 1% deuterated alcohol (alcohol-d6) to make the distinction
between alcohol from the hand disinfection product and other sources.
Study burden and risks
Burden and risk for the study participants:
- Participants are asked to avoid certain food/beverages that contain ethanol
and/or lead to increased endogenous production for a period of 24 h prior to
the study.
- Complete a questionnaire related to job title/tasks, use of food/beverages
and personal care products with a focus on skin care
- Four one-day visits to the lab for the ABHR application. The lab visits are
planned with a delay of at least 24 h wash-out period
- On each of four days a series of 10 blood samples of 3 mL over a period of 4
h hours
- On each of four days a series of 10 end-exhaled air over a period of 4 hours
- Blood collection by venepuncture may cause pain and/or localised haemorrhage
- Skin contact may cause mild irritation. Irritation of the eyes will be
prevented by wearing of goggles.
- This exposure to the hand disinfection product is not expected to cause any
long-term risk of significance
Heyendaalseweg 135
Nijmegen 6525 AJ
NL
Heyendaalseweg 135
Nijmegen 6525 AJ
NL
Listed location countries
Age
Inclusion criteria
- Caucasian descent
- Employment in the healthcare (hospital, GGD or similar)
- Applying >25 ABHR/work shift for at least 3 full shifts/week
- 18-55y
Exclusion criteria
- Skin disease
- Liver disease
- Pregnancy
- Breastfeeding
Design
Recruitment
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 | NL83686.091.23 |