The objective of this studie is to gather knowledge about cytokine concentrations (IL-1 *) in the skin of healthy volunteers after the application of shear- force. We want to use this knowledge in the future to investigate if different prophylactic…
ID
Source
Brief title
Condition
- Skin and subcutaneous tissue disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
IL-1 * concentration (pg/ml)
Secondary outcome
Bloodflow
Erythema index
Background summary
A pressure ulcer is localized tissue injury to the superficial layer of the
skin and/ or the underlying tissue. Pressure ulcers are most likely to develop
in skin areas exposed to pressure, shear and friction. Shear- force is an
important contributing factor and wound dressing are possibly capable to reduce
shear force at the skin. At this moment there's nog good marker to detect the
effect of shear- force at the skin. A potential marker could be cytokines
(IL-1*) which are released after mechanical loading of the skin. A previous
studie have shown a significant increased level of IL-1* after the application
of pressure. We want to investigate if these cytokines are significant
increased after the application of shear- force at the skin.
Study objective
The objective of this studie is to gather knowledge about cytokine
concentrations (IL-1 *) in the skin of healthy volunteers after the application
of shear- force. We want to use this knowledge in the future to investigate if
different prophylactic wound dressings are capable to reduce shear force at the
skin. This could be interesting in the prevention of pressure ulcers.
Study design
With the use of a special developed shear- force model are we going to
administer 19 Newton (2 kg) shear at the palmar side of the under arm in 10
healthy volunteers. As a control we ware going to put the shear- force model at
the other arm without the application of shear- force. Before the use of the
shear- force model we will mark an area of 2,5 cm by 3 cm in the centre where
the shear pad is going to be placed and perform cytokine measurements with the
use of Sebutape in this area. Sebutape is capable to absorp cytokines from the
skin. After that we will measure the bloodflow with lasserdoppler (MoorLDI2)
and the erythema index with the use of a colorimeter (DSMII Colormeter). After
the use of the shear force- model we will perform cytokine, bloodflow and
erythema index measurements again.
At another research day, we follow the same procedure but this time we are
going to apply 15 minutes shear and 15 minutes pressure instead of 30 minutes.
Then we will extract the cytokines from the Sebutape with the use of ELISA.
Study burden and risks
There's no risk involved for the healthy volunteers, because the shear- force
in normal life can range between 0- 100 N. We will only administer 19 N which
is much lower. We will work with healthy volunteers with a low risk on the
development of pressure ulcers.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
Healthy volunteers (male)
Age 20- 30 years
BMI 20- 30
Braden score > 20
Exclusion criteria
Injury lower arms
Skin diseases (psoriasis, eczema)
Not able to give informed consent
Malignicy
Muscle disorders
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 | NL46877.068.13 |
Other | volgt nog via clinicaltrials.gov |