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Completed

NCT Number: NCT02474979

Reduced Pressure for Less Pressure Ulcers

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

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Akademiska sjukhuset

Uppsala, Uppland, 75125, Sweden

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CBPM-system

Device

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

Other

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • Wellsense USA Inc.

Registry information

Official study title

Reduced Pressure for Less Pressure Ulcers. Effect of the CBPM-system in a Swedish University Hospital

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 18, 2015
Registry last updated
Mar 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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