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Reduced Pressure for Less Pressure Ulcers

Primary Purpose

Pressure Ulcer

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
CBPM-system
Control
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pressure Ulcer focused on measuring Pressure ulcer, Prevention, Pressure mapping

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Akademiska sjukhuset

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

CBPM-system

Control

Arm Description

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).

Standard pressure ulcer prevention (PU reducing mattress, floating heels, repositioning).

Outcomes

Primary Outcome Measures

PU prevalence (Category 1-4) - change from baseline
The most severe PU for each patient is included in the calculation

Secondary Outcome Measures

Number of PU per category and patient
Category 1-4
Number of preventive interventions
pressure reducing mattress, heel cushions, repositioning, repositioning aid, preventive dressing
Patient´s experience of comfort in bed
Visual Analog Scale 1-10
Peak pressure
mmHg (mean)

Full Information

First Posted
May 27, 2015
Last Updated
March 11, 2016
Sponsor
Uppsala University
Collaborators
Wellsense USA Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02474979
Brief Title
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

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uppsala University
Collaborators
Wellsense USA Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer
Keywords
Pressure ulcer, Prevention, Pressure mapping

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
190 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBPM-system
Arm Type
Experimental
Arm Description
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).
Arm Title
Control
Arm Type
Experimental
Arm Description
Standard pressure ulcer prevention (PU reducing mattress, floating heels, repositioning).
Intervention Type
Device
Intervention Name(s)
CBPM-system
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Primary Outcome Measure Information:
Title
PU prevalence (Category 1-4) - change from baseline
Description
The most severe PU for each patient is included in the calculation
Time Frame
admission to discharge or last assessment at 14 days
Secondary Outcome Measure Information:
Title
Number of PU per category and patient
Description
Category 1-4
Time Frame
admission to discharge or last assessment at 14 days
Title
Number of preventive interventions
Description
pressure reducing mattress, heel cushions, repositioning, repositioning aid, preventive dressing
Time Frame
admission to discharge or last assessment at 14 days
Title
Patient´s experience of comfort in bed
Description
Visual Analog Scale 1-10
Time Frame
admission to discharge or last assessment at 14 days
Title
Peak pressure
Description
mmHg (mean)
Time Frame
admission to discharge or last assessment at 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lena Gunningberg, Professor
Organizational Affiliation
Uppsala University, Uppsala, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Akademiska sjukhuset
City
Uppsala
State/Province
Uppland
ZIP/Postal Code
75125
Country
Sweden

12. IPD Sharing Statement

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Reduced Pressure for Less Pressure Ulcers

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