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NCT02348671 Clinical Trial

Evaluation of Wound Dressings in the Reduction of Shear- Force

Pressure Ulcer Clinical Trial

Official title:
Evaluation of Wound Dressings to Reduce the Harmful Effects of Shear- Force at the Skin

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02348671
Other study ID # SF-2
Secondary ID
Status Completed
Phase N/A
First received December 1, 2014
Last updated September 22, 2015
Start date March 2015
Est. completion date July 2015

Study information
Verified date January 2015
Source Maastricht University Medical Center
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Observational

Clinical Trial Summary

The purpose of this study is to investigate if wound dressings are capable in reducing the effects of shear- force at the skin. With our own shear- force model we are able to apply 19 Newton shear- force combined with 9 newton pressure at the skin of the non- dominant forearm. After half an hour we measure IL-1alpha/ total protein- ratio, cutaneous blood flow (Laser doppler, Moor LDI) and the erythema index (DSMIIColormeter) which occurs as an effect of shear- force application at the skin.

Then, we apply 19 Newton shear- force combined with 9 Newton pressure at the dominant fore-arm but this time we put a wound dressing between the skin and shear- force model. After half an hour we measure the IL-1alpha/total protein-ratio, cutaneous blood flow and the erythema index.

This research consists of three research day, each day we are going to investigate a different wound dressing

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date July 2015
Est. primary completion date June 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria:

- healhty volunteer

- age 18- 30

- BMI 20- 30

Exclusion Criteria:

- Trauma fore-arms

- Diabetes mellitus type I or type II

- The use of NSAID's in the last 7 days

- Vascular diseases

- Muscular dystrophy

- Malignancy

- Participant is unable to give informed consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• shear- force
19 Newton shear- force and 3,9 kPa pressure for half an hour

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Maastricht University Medical Center

Outcome
Type Measure Description Time frame Safety issue
Primary Cutaneous blood flow, erythema index, IL-1alpha/Total protein ratio Directly after intevention No
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