Reduced Pressure for Less Pressure Ulcers

Pressure Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02474979
• Other study ID #: EPN2014/529
• Status: Completed
• Phase: N/A
• First received: May 27, 2015
• Last updated: March 11, 2016
• Start date: March 2015
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pressure Ulcer
• Ulcer

Intervention

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.

Other:
• Control

Locations

Country	Name	City	State
Sweden	Akademiska sjukhuset	Uppsala	Uppland

Sponsors (2)

Lead Sponsor	Collaborator
Uppsala University	Wellsense USA Inc.

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Number of PU per category and patient	Category 1-4	admission to discharge or last assessment at 14 days	Yes
Secondary	Number of preventive interventions	pressure reducing mattress, heel cushions, repositioning, repositioning aid, preventive dressing	admission to discharge or last assessment at 14 days	Yes
Secondary	Patient´s experience of comfort in bed	Visual Analog Scale 1-10	admission to discharge or last assessment at 14 days	Yes
Secondary	Peak pressure	mmHg (mean)	admission to discharge or last assessment at 14 days	Yes