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

Completed

• Conditions: Pressure Ulcers, Bedsores, Decubitus Ulcer
• Interventions: Other: Shear- force model

• Registration Number: NCT02020655
• Lead Sponsor: Maastricht University Medical Center

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-05
• Study First Submitted QC: 2013-12-19
• Study First Posted: 2013-12-25
• Study Start: 2014-11
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-01
• Last Update Posted: 2014-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
10 healthy volunteers	Shear- force model	Shear- force model

Primary Outcome Measures

Name	Time	Method
IL-1 α concentration (pg/ml)	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.

Trial Locations

Locations (1)

Maastricht University medical Centre; 🇳🇱 Maastricht, Limburg, Netherlands