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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01438541
First Posted: September 22, 2011
Last Update Posted: October 14, 2016
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.
Information provided by (Responsible Party):
Molnlycke Health Care AB
  Purpose

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 Intervention Phase
Pressure Ulcer Device: Window Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Molnlycke Health Care AB:

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


Secondary Outcome Measures:
  • 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

  • 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


Enrollment: 29
Study Start Date: September 2011
Study Completion Date: April 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Dressing

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01438541


Locations
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
Investigators
Principal Investigator: Carol Dealey, BSc University Hospital Birmingham NHS
  More Information

Responsible Party: Molnlycke Health Care AB
ClinicalTrials.gov Identifier: NCT01438541     History of Changes
Other Study ID Numbers: Window 02
First Submitted: September 13, 2011
First Posted: September 22, 2011
Results First Submitted: May 13, 2016
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
Prevention
protection of the skin

Additional relevant MeSH terms:
Pressure Ulcer
Skin Ulcer
Skin Diseases