Pressure Ulcers, Bedsores, Decubitus Ulcer Clinical Trial
Official title:
Measurement of Cytokines (IL-1α) After Shear- Force Application at the Skin
Background: 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 no good marker to detect the effect of shear- force at the skin. A potential marker
could be cytokines (IL-1α) which are released after mechanical loading of the skin. A
previous study have shown a significant increased level of IL-1α after the application of
pressure. We want to investigate if these cytokines are significant increased after the
application of shear- force at the skin.
Objective: The objective of this study is to gather knowledge about cytokine concentrations
(IL-1 α) 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 20 Newton (2 kg) shear at the palmar side of the under arm in 10 healthy
volunteers for 30 minutes. 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 perform cytokine measurements with the use of Sebutape. Sebutape is capable to
absorb cytokines from the skin. After the use of the shear force- model we will perform
cytokine measurements again. Then we will extract the cytokines from the Sebutape with the
use of ELISA.
Study population: 10 Healthy volunteers Age 18- 30 years
Primary outcome: IL-1 α concentration (pg/ml)
| Status | Completed |
| Enrollment | 10 |
| Est. completion date | November 2014 |
| Est. primary completion date | November 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 30 Years |
| Eligibility |
Inclusion Criteria: - Age 18- 30 years - BMI 20 -30 - Braden score > 20 Exclusion Criteria: - Trauma arms - Skin diseases (eczema, psoriasis) - Inability to give informed consent - Muscle disorders - malignancy |
Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Maastricht University medical Centre | Maastricht | Limburg |
| Lead Sponsor | Collaborator |
|---|---|
| Maastricht University Medical Center |
Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | IL-1 a concentration (pg/ml) | With the use of a special developed shear- force model are we going to administer 20 Newton (2 kg) shear at the palmar side of the under arm in 10 healthy volunteers for 30 minutes. 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 perform cytokine measurements with the use of Sebutape. Sebutape is capable to absorb cytokines from the skin. After the use of the shear force- model we will perform cytokine measurements again. | up to 24 hours | No |