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Measurement of Cytokines (IL-1α) After Shear- Force Application at the Skin

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ClinicalTrials.gov Identifier: NCT02020655
Recruitment Status : Completed
First Posted : December 25, 2013
Last Update Posted : December 2, 2014
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Study Description
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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)


Condition or disease Intervention/treatment
Pressure Ulcers, Bedsores, Decubitus Ulcer Other: Shear- force model

Study Design
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Study Type : Observational
Actual Enrollment : 10 participants
Time Perspective: Prospective
Official Title: Measurement of Cytokines (IL-1α) After Shear- Force Application at the Skin
Study Start Date : November 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores

Groups and Cohorts
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Group/Cohort Intervention/treatment
10 healthy volunteers
Shear- force model
 Other: Shear- force model
Shear- force model


Outcome Measures
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Primary Outcome Measures :
  1. IL-1 α concentration (pg/ml) [ Time Frame: up to 24 hours ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
10 healthy volunteers
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02020655


Locations
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Netherlands
Maastricht University medical Centre
Maastricht, Limburg, Netherlands, 6229 HX
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
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Study Chair: Nicole Bouvy, MD, PhD Department of surgery, Maastricht University Medical Centre
More Information
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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02020655    
Other Study ID Numbers: NL46877.068.13
First Posted: December 25, 2013    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: December 2014
Keywords provided by Maastricht University Medical Center:
IL-1 alpha, Sebutape, shear- force
Additional relevant MeSH terms:
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Pressure Ulcer
Skin Ulcer
Skin Diseases