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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:
Information provided by (Responsible Party):
Molnlycke Health Care AB
ClinicalTrials.gov Identifier:
NCT01438541
First received: September 13, 2011
Last updated: July 2, 2012
Last verified: July 2012
History of Changes
  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: 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

Resource links provided by NLM:

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

Further study details as provided by Molnlycke Health Care AB:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


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: 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.
 Device: Window
Dressing

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Molnlycke Health Care AB
ClinicalTrials.gov Identifier: NCT01438541     History of Changes
Other Study ID Numbers: Window 02
Study First Received: September 13, 2011
Last Updated: July 2, 2012
Health Authority: United Kingdom: National Health Service

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

Additional relevant MeSH terms:
Pressure Ulcer
Ulcer
Skin Ulcer
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013