Evaluation of Wound Dressings in the Reduction of Shear- Force

September 22, 2015 updated by: Maastricht University Medical Center

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

10

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Ten healthy volunteers

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cutaneous blood flow, erythema index, IL-1alpha/Total protein ratio
Time Frame: Directly after intevention
Directly after intevention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

December 1, 2014

First Submitted That Met QC Criteria

January 22, 2015

First Posted (Estimate)

January 28, 2015

Study Record Updates

Last Update Posted (Estimate)

September 23, 2015

Last Update Submitted That Met QC Criteria

September 22, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SF-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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