A Multi-centre Evaluation of the Performance of Window Dressings on Subjects With High Risk Pressure Ulceration
This study will be conducted in approximately 26 subjects in UK to yield 20 evaluable subjects at 3 sites with approximately 5-10 subjects/site. Subjects with acute vascular, surgical and orthopaedic medical care in the elderly admission, with a high risk to develop skin breakdown or subjects with category 1 pressure ulcer can be enrolled in this investigation.
The rational for this study is to evaluate the potential for Window in the prevention of pressure ulcers because of its ability to reduce shear and friction forces.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Multi-centre, Post CE-mark, Open Study to Evaluate the Performance of Thin Self-adherent Dressing Coated With a Soft Silicone Layer on Subjects With High Risk of Category 2 or Above Pressure Ulceration|
- Erythema ( No/Yes) [ Time Frame: 14 days ] [ Designated as safety issue: No ]Total improvement of erythema
- Overall Experience of Use of the Dressing [ Time Frame: 14 days ] [ Designated as safety issue: No ]Investigator and Nurses evaluate the overall Experience of using of the dressing rated on a scale from Very Poor, Poor,Good, Very Good, Excellent, Not measured
- Evaluate the Dressing Shape [ Time Frame: 14 days ] [ Designated as safety issue: No ]Investigator and Nurses evaluated the shape of the dressing rated on a scale from Very Poor, Poor,Good, Very Good, Excellent
|Study Start Date:||September 2011|
|Study Completion Date:||April 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown. Window TM provides instant tack adhesion that minimizes the requirement of extra pressure in order to fixate well. The product does not leave residues and the adhesion level does not increase over time.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01438541
|University Hospitals Birmingham NHS|
|Birmingham, United Kingdom, B152TH|
|Leeds General Infirmary|
|Leeds, United Kingdom, LS1 3EX|
|The Mid Yourkshire Hospitals NHS Trust|
|Wakefield, United Kingdom, WF1 4DG|
|Principal Investigator:||Carol Dealey, BSc||University Hospital Birmingham NHS|