Status:
COMPLETED
A Multi-centre Evaluation of the Performance of Window Dressings on Subjects With High Risk Pressure Ulceration
Lead Sponsor:
Molnlycke Health Care AB
Conditions:
Pressure Ulcer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT01438541
Start Date
September 1 2011
End Date
April 1 2012
Last Update
October 14 2016
Active Locations (3)
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1
University Hospitals Birmingham NHS
Birmingham, United Kingdom, B152TH
2
Leeds General Infirmary
Leeds, United Kingdom, LS1 3EX
3
The Mid Yourkshire Hospitals NHS Trust
Wakefield, United Kingdom, WF1 4DG