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Reduced Pressure for Less Pressure Ulcers

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ClinicalTrials.gov Identifier: NCT02474979
Recruitment Status : Completed
First Posted : June 18, 2015
Last Update Posted : March 14, 2016
Sponsor:
Collaborator:
Wellsense USA Inc.
Information provided by (Responsible Party):
Uppsala University

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

Condition or disease Intervention/treatment Phase
Pressure Ulcer Device: CBPM-system Other: Control Not Applicable

Detailed Description:

Background The first national PU prevalence study in Sweden conducted in 2011 showed a prevalence of 16.6% (n=16 466) in hospital settings. High age and reduced mobility/activity are main risk factors. International evidence-based guidelines for prevention of PU are available. Pressure relief (e.g repositioning, mattresses, chair cushions, heel cushions) is the main stay of preventive measures. Recent research shows that PU prevention is not a high priority. For example, the corner stone of prevention, repositioning, is not conducted for risk patients.

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).


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Reduced Pressure for Less Pressure Ulcers. Effect of the CBPM-system in a Swedish University Hospital
Study Start Date : March 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores

Arm Intervention/treatment
Experimental: 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).
Device: 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.

Experimental: Control
Standard pressure ulcer prevention (PU reducing mattress, floating heels, repositioning).
Other: Control



Primary Outcome Measures :
  1. PU prevalence (Category 1-4) - change from baseline [ Time Frame: admission to discharge or last assessment at 14 days ]
    The most severe PU for each patient is included in the calculation


Secondary Outcome Measures :
  1. Number of PU per category and patient [ Time Frame: admission to discharge or last assessment at 14 days ]
    Category 1-4

  2. Number of preventive interventions [ Time Frame: admission to discharge or last assessment at 14 days ]
    pressure reducing mattress, heel cushions, repositioning, repositioning aid, preventive dressing

  3. Patient´s experience of comfort in bed [ Time Frame: admission to discharge or last assessment at 14 days ]
    Visual Analog Scale 1-10

  4. Peak pressure [ Time Frame: admission to discharge or last assessment at 14 days ]
    mmHg (mean)



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Admitted to geriatric unit 30A during Sunday after 4 pm to Friday until 4 pm

Exclusion Criteria:

  • Expected to be discharged before data collection in day 3

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02474979


Locations
Sweden
Akademiska sjukhuset
Uppsala, Uppland, Sweden, 75125
Sponsors and Collaborators
Uppsala University
Wellsense USA Inc.
Investigators
Principal Investigator: Lena Gunningberg, Professor Uppsala University, Uppsala, Sweden

Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT02474979     History of Changes
Other Study ID Numbers: EPN2014/529
First Posted: June 18, 2015    Key Record Dates
Last Update Posted: March 14, 2016
Last Verified: March 2016

Keywords provided by Uppsala University:
Pressure ulcer
Prevention
Pressure mapping

Additional relevant MeSH terms:
Ulcer
Pressure Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases