Reduced Pressure for Less Pressure Ulcers
1 other identifier
interventional
190
1 country
1
Brief Summary
Pressure ulcers (PU) cause pain and discomfort to affected patients, as well as considerable costs for society. The present study will evaluate the effect of the Continuous Bedside Pressure Mapping (CBPM)- system on PU prevalence and incidence. A RCT including 180 patients will be conducted in a geriatric setting in a Swedish University hospital
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 27, 2015
CompletedFirst Posted
Study publicly available on registry
June 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedMarch 14, 2016
March 1, 2016
9 months
May 27, 2015
March 11, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PU prevalence (Category 1-4) - change from baseline
The most severe PU for each patient is included in the calculation
admission to discharge or last assessment at 14 days
Secondary Outcomes (4)
Number of PU per category and patient
admission to discharge or last assessment at 14 days
Number of preventive interventions
admission to discharge or last assessment at 14 days
Patient´s experience of comfort in bed
admission to discharge or last assessment at 14 days
Peak pressure
admission to discharge or last assessment at 14 days
Study Arms (2)
CBPM-system
EXPERIMENTALCBPM-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).
Control
EXPERIMENTALStandard pressure ulcer prevention (PU reducing mattress, floating heels, repositioning).
Interventions
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.
Eligibility Criteria
You may qualify if:
- Admitted to geriatric unit 30A during Sunday after 4 pm to Friday until 4 pm
You may not qualify if:
- Expected to be discharged before data collection in day 3
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Uppsala Universitylead
- Wellsense USA Inc.collaborator
Study Sites (1)
Akademiska sjukhuset
Uppsala, Uppland, 75125, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lena Gunningberg, Professor
Uppsala University, Uppsala, Sweden
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2015
First Posted
June 18, 2015
Study Start
March 1, 2015
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
March 14, 2016
Record last verified: 2016-03