Evaluation of Wound Dressings in the Reduction of Shear- Force

NCT02348671 | Completed DMC

• 1 other identifier: SF-2
• Study Type: observational
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Pressure Ulcer

Outcome Measures

Primary Outcomes (1)

• Cutaneous blood flow, erythema index, IL-1alpha/Total protein ratio

  Directly after intevention

Interventions

shear- force OTHER

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

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Ten healthy volunteers

You may qualify if:

• healhty volunteer
• age 18- 30
• BMI 20- 30

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2014
• First Posted: January 28, 2015
• Study Start: March 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: July 1, 2015
• Last Updated: September 23, 2015

Record last verified: 2015-01