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OpenTrials
Completed

NCT Number: NCT01438541

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

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.

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Key information

Conditions

Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospitals Birmingham NHS, Birmingham, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Window

Device

Dressing

Primary outcomes

  1. Erythema ( No/Yes)

    Time frame: 14 days

    Total improvement of erythema

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Molnlycke Health Care AB

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 22, 2011
Registry last updated
Oct 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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