A Multi-centre Evaluation of the Performance of Window Dressings on Subjects With High Risk Pressure Ulceration

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Pressure Ulcer

Intervention / Treatment
-----------------
* Device: Window


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute vascular, surgical, orthopaedic, medical or care of the elderly admission aged 18 years or over have an expected total length of stay of 5 or more days at high risk of PU development due to one or more of the following bedfast/chairfast AND completely immobile/very limited mobility category 1 PU on any pressure area skin site (see appendix G) give their written, informed consent to participate expected to be able to comply with follow-up schedule Exclusion Criteria: risk area which doesn't fit the dressing size 6*7cm, 10*12 cm and 15*20cm subject has category 2-4 pressure ulcer subject has documented skin disease at time of enrolment, as judged by the investigator known allergy/hypersensitivity to any of the components in the dressing previous enroled in the present study subject included in other ongoing clinical investigation at present, as judged by the investigator

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Window<br>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. | Device: Window<br>* Dressing<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erythema ( No/Yes) | Total improvement of erythema | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Experience of Use of the Dressing | 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 | 14 days | 
| Evaluate the Dressing Shape | Investigator and Nurses evaluated the shape of the dressing rated on a scale from Very Poor, Poor,Good, Very Good, Excellent | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
No skin breakdown, Prevention, protection of the skin