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|
- No skin breakdown during the study period, by observation of the skin. [ Time Frame: 14 days ] [ Designated as safety issue: No ]To evaluate the performance of a thin self-adherent dressing in preventing the development of category 2 and above pressure ulcers in vulnerable subjects with a high risk of skin breakdown.
- Conformability of a dressing [ Time Frame: 14 days ] [ Designated as safety issue: No ]To investigate the conformability of a thin self-adherent dressing coated with a soft silicone layer in this subject population.How the dressing reacts when it comes to stay on ability and skin status according to nurse evaluation.
- Performance of a dressing [ Time Frame: 14 days ] [ Designated as safety issue: No ]Occular observation of the performance of a thin self-adherent dressing coated with a soft silicone layer in this subject population.
|Study Start Date:||September 2011|
|Study Completion Date:||April 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Experimental: Device, dressing
Window is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown. Window is skin-friendly and safe.
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|