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

Primary Purpose

Pressure Ulcer

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Window
Sponsored by
Molnlycke Health Care AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pressure Ulcer focused on measuring No skin breakdown, Prevention, protection of the skin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospitals Birmingham NHS
  • Leeds General Infirmary
  • The Mid Yourkshire Hospitals NHS Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Window

Arm Description

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.

Outcomes

Primary Outcome Measures

Erythema ( No/Yes)
Total improvement of erythema

Secondary Outcome Measures

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
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

Full Information

First Posted
September 13, 2011
Last Updated
August 22, 2016
Sponsor
Molnlycke Health Care AB
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1. Study Identification

Unique Protocol Identification Number
NCT01438541
Brief Title
A Multi-centre Evaluation of the Performance of Window Dressings on Subjects With High Risk Pressure Ulceration
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 Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Molnlycke Health Care AB

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer
Keywords
No skin breakdown, Prevention, protection of the skin

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Window
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Window
Intervention Description
Dressing
Primary Outcome Measure Information:
Title
Erythema ( No/Yes)
Description
Total improvement of erythema
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Overall Experience of Use of the Dressing
Description
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
Time Frame
14 days
Title
Evaluate the Dressing Shape
Description
Investigator and Nurses evaluated the shape of the dressing rated on a scale from Very Poor, Poor,Good, Very Good, Excellent
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol Dealey, BSc
Organizational Affiliation
University Hospital Birmingham NHS
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Birmingham NHS
City
Birmingham
ZIP/Postal Code
B152TH
Country
United Kingdom
Facility Name
Leeds General Infirmary
City
Leeds
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
Facility Name
The Mid Yourkshire Hospitals NHS Trust
City
Wakefield
ZIP/Postal Code
WF1 4DG
Country
United Kingdom

12. IPD Sharing Statement

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

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