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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01438541
Recruitment Status : Completed
First Posted : September 22, 2011
Results First Posted : October 14, 2016
Last Update Posted : October 14, 2016
Information provided by (Responsible Party):
Molnlycke Health Care AB

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.

Condition or disease Intervention/treatment Phase
Pressure Ulcer Device: Window Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Window
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

Primary Outcome Measures :
  1. Erythema ( No/Yes) [ Time Frame: 14 days ]
    Total improvement of erythema

Secondary Outcome Measures :
  1. Overall Experience of Use of the Dressing [ Time Frame: 14 days ]
    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

  2. Evaluate the Dressing Shape [ Time Frame: 14 days ]
    Investigator and Nurses evaluated the shape of the dressing rated on a scale from Very Poor, Poor,Good, Very Good, Excellent

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. acute vascular, surgical, orthopaedic, medical or care of the elderly admission
  2. aged 18 years or over
  3. have an expected total length of stay of 5 or more days
  4. 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)
  5. give their written, informed consent to participate
  6. expected to be able to comply with follow-up schedule

Exclusion Criteria:

  1. risk area which doesn't fit the dressing size 6*7cm, 10*12 cm and 15*20cm
  2. subject has category 2-4 pressure ulcer
  3. subject has documented skin disease at time of enrolment, as judged by the investigator
  4. known allergy/hypersensitivity to any of the components in the dressing
  5. previous enroled in the present study
  6. subject included in other ongoing clinical investigation at present, as judged by the investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01438541

United Kingdom
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
Sponsors and Collaborators
Molnlycke Health Care AB
Principal Investigator: Carol Dealey, BSc University Hospital Birmingham NHS

Responsible Party: Molnlycke Health Care AB Identifier: NCT01438541     History of Changes
Other Study ID Numbers: Window 02
First Posted: September 22, 2011    Key Record Dates
Results First Posted: October 14, 2016
Last Update Posted: October 14, 2016
Last Verified: August 2016

Keywords provided by Molnlycke Health Care AB:
No skin breakdown
protection of the skin

Additional relevant MeSH terms:
Pressure Ulcer
Skin Ulcer
Skin Diseases