Study Results
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Basic Information
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COMPLETED
NA
190 participants
INTERVENTIONAL
2015-03-31
2015-12-31
Brief Summary
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Detailed Description
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Aim To evaluate the effect of the CBPM-system on the prevalence and incidence of PU in hospital setting
Method Design: A randomised controlled trial will be conducted Sample: All patients admitted to the geriatric unit. Intervention: The CBPM-system will be used from admittance to discharge (not more than 14 days). Standard PU prevention (PU reducing mattress, floating heels, repositioning) Control group: Standard PU prevention (PU reducing mattress, floating heels, repositioning) Randomisation: Sealed envelopes will be used. Procedure: Two study nurses are responsible for inclusion of patients and data collection on day 1,3,7 and discharge. A photo will be taken of any PU. A PU expert will assess the photos after completed data collection (PU category 1-4). She will be blinded to group allocation.
Power calculation: The primary outcome of interest is the PU prevalence. Previous point prevalence studies in this geriatric unit shows a prevalence of 45%. The investigators goal is that the CBPM-system results in 20% decrease in the PU prevalence. In order to have 80% power to detect such a decrease with a two-sided two-sample proportions test at the 5% level, 89 patients per treatment group is needed. Intention-to-treat principals will be used.
Discussion The prevalence of PU, as well as prevention to risk patients are quality indicators in health care. National studies reveal an urgent need for quality improvement, New nursing methods and equipment must be systematically and scientifically evaluated.The results of this study will be valuable for nursing education and in international and national patient safety work to prevent PU. The results will also be valuable for other health professionals (physicians, physical and occupational therapists).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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CBPM-system
CBPM-system (Continuous Bedside Pressure Mapping System): the bed is equipped with a pressure sensing mat including thousands of sensors. It is connected with a monitor that continuously registers the pressure between the body and the bed surface (interface pressure). The pressure is indicated by colors, where warmer colors indicate higher pressure. The CBPM-system will be used in addition to standard pressure ulcer prevention (PU reducing mattress, floating heels, repositioning).
CBPM-system
The bed is equipped with a pressure sensing mat including thousands of sensors. It is connected with a monitor that continuously registers the pressure between the body and the bed surface (interface pressure). The pressure is indicated by colors, where warmer colors indicate higher pressure.
Control
Standard pressure ulcer prevention (PU reducing mattress, floating heels, repositioning).
Control
Interventions
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CBPM-system
The bed is equipped with a pressure sensing mat including thousands of sensors. It is connected with a monitor that continuously registers the pressure between the body and the bed surface (interface pressure). The pressure is indicated by colors, where warmer colors indicate higher pressure.
Control
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
50 Years
ALL
No
Sponsors
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Wellsense USA Inc.
INDUSTRY
Uppsala University
OTHER
Responsible Party
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Principal Investigators
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Lena Gunningberg, Professor
Role: PRINCIPAL_INVESTIGATOR
Uppsala University, Uppsala, Sweden
Locations
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Akademiska sjukhuset
Uppsala, Uppland, Sweden
Countries
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Other Identifiers
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EPN2014/529
Identifier Type: -
Identifier Source: org_study_id
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