Clinical trial NCT02474979: Reduced Pressure for Less Pressure Ulcers
Official title: Reduced Pressure for Less Pressure Ulcers. Effect of the CBPM-system in a Swedish University Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Ulcer
Keywords: Pressure ulcer
Prevention
Pressure mapping
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Wellsense USA Inc.
First posted: 2015-06-18
Enrollment: 190
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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).

Eligibility 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

Primary outcomes:
measure: PU prevalence (Category 1-4) - change from baseline
timeFrame: admission to discharge or last assessment at 14 days
Secondary outcomes:
measure: Number of PU per category and patient
timeFrame: admission to discharge or last assessment at 14 days
measure: Number of preventive interventions
timeFrame: admission to discharge or last assessment at 14 days
measure: Patient´s experience of comfort in bed
timeFrame: admission to discharge or last assessment at 14 days
measure: Peak pressure
timeFrame: admission to discharge or last assessment at 14 days
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset
state: Uppland
Study officials:
affiliation: Uppsala University, Uppsala, Sweden
name: Lena Gunningberg, Professor
role: PRINCIPAL_INVESTIGATOR
References: