Clinical Trial: Reduced Pressure for Less Pressure Ulcers

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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

Detailed Summary:

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 principa
Sponsor: Uppsala University

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of PU per category and patient [ Time Frame: admission to discharge or last assessment at 14 days ]
    Category 1-4
  • 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
  • Patient´s experience of comfort in bed [ Time Frame: admission to discharge or last assessment at 14 days ]
    Visual Analog Scale 1-10
  • Peak pressure [ Time Frame: admission to discharge or last assessment at 14 days ]
    mmHg (mean)


Original Secondary Outcome: Same as current

Information By: Uppsala University

Dates:
Date Received: May 27, 2015
Date Started: March 2015
Date Completion:
Last Updated: March 11, 2016
Last Verified: March 2016