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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01438541 |
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Date of registration:
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13/09/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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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 |
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Date of first enrolment:
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September 2011 |
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Target sample size:
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29 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01438541 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 4
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Carol Dealey, BSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital Birmingham NHS |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pressure Ulcer
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Intervention(s)
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Device: Window
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Primary Outcome(s)
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Erythema ( No/Yes)
[Time Frame: 14 days]
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Secondary Outcome(s)
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Overall Experience of Use of the Dressing
[Time Frame: 14 days]
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Evaluate the Dressing Shape
[Time Frame: 14 days]
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Secondary ID(s)
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Window 02
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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