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

NCT ID: NCT02020655

Last Updated: 2014-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

Study Completion Date

2014-11-30

Brief Summary

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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)

Detailed Description

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Conditions

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Pressure Ulcers, Bedsores, Decubitus Ulcer

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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10 healthy volunteers

Shear- force model

Shear- force model

Intervention Type OTHER

Shear- force model

Interventions

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Shear- force model

Shear- force model

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicole Bouvy, MD, PhD

Role: STUDY_CHAIR

Department of surgery, Maastricht University Medical Centre

Locations

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Maastricht University medical Centre

Maastricht, Limburg, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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NL46877.068.13

Identifier Type: -

Identifier Source: org_study_id