Measurement of Cytokines (IL-1α) After Shear- Force Application at the Skin
1 other identifier
observational
10
1 country
1
Brief Summary
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 5, 2013
CompletedFirst Posted
Study publicly available on registry
December 25, 2013
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2014
CompletedDecember 2, 2014
December 1, 2014
Same day
November 5, 2013
December 1, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
IL-1 α 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
Study Arms (1)
10 healthy volunteers
Shear- force model
Interventions
Eligibility Criteria
10 healthy volunteers
You may qualify if:
- Age 18- 30 years
- BMI 20 -30
- Braden score \> 20
You may not qualify if:
- Trauma arms
- Skin diseases (eczema, psoriasis)
- Inability to give informed consent
- Muscle disorders
- malignancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maastricht University medical Centre
Maastricht, Limburg, 6229 HX, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Nicole Bouvy, MD, PhD
Department of surgery, Maastricht University Medical Centre
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2013
First Posted
December 25, 2013
Study Start
November 1, 2014
Primary Completion
November 1, 2014
Study Completion
November 1, 2014
Last Updated
December 2, 2014
Record last verified: 2014-12