Comparing Pressure Injury Occurrence in Patients Using Two Different Mattresses

Technology
Skin health
Online since 13 March 2022, updated 714 days ago

About this trial

The purpose of this project is to compare a newly developed automatic reversing dynamic air mattress, with a regular care mattress, which is in daily use at the hospital. Focus will be on pressure rel...

Included participants

Gender
All
Age
≥ 18 years
Injury level
Level not specified
  • Severity (AIS)?
  • Time since injury
    All
    Healthy volunteers
    No
    Level not specified

    What’s involved

    Type

    Technology

    Details

    The investigators will conduct a randomized cross over testing, where the purpose is to compare an intervention mattress and a regular care mattress in relation to occurrence of pressure relief, experienced sleep comfort, pain and quality of life in the participants. Further on, the investigators want to examine staff needed to assist in position change of the participants, as well as physical strain for the staff. To secure safe use of the intervention mattress, a noise-test and a pressure assessment test of the mattresses have been performed in advance of the research project. A pressure limit is defined, based on current evidence based knowledge regarding pressure injury risk. If this limit is exceeded during the project period, the participant will be excluded from further testing, due to a potential increased risk of pressure injury development. Written and oral information regarding the project will be given, and the participants will give a written concent before inclusion. The regular care mattress, used as control in this trial, is considered one of the best pressure relieving mattresses available in Norway. Ten participants will be included and randomized to start with the intervention mattress or the control mattress. Baseline data regarding gender, age, level and severity of the spinal injury, together with pressure injury associated dysfunction, like increased sweat, bladder and bowel incontinency will be collected immediately after inclusion. The investigators will also ask for information of comorbidity previous to the spinal injury, including cardiovascular disease, embolisms or diabetes mellitus. Pressure monitoring will be performed before start up, and validated questionnaires will be used in assessing pressure injury risk, pain and quality of life. Pressure injury occurrence will be assessed every day. After seven days use of the first mattress, new data will be collected, by means of validated forms regarding pain occurrence, noise from the mattress devices, sleeping wellness and participant satisfaction. Custom made forms regarding resource use in the nursing staff, especially at night and in relation to position change, will be collected, together with data regarding physical strain in the staff. The participant will then change to the other mattress and pressure monitoring will be performed. If acceptable results, the participant will use this mattress for seven days. Pressure injury occurrence will be assessed every day. Then a end-of-study data assessment will be performed, similar to the questionnaires used in the intervention mattress. Finally, in-depth interviews will be performed in one participants and one nurse finishing the study on the intervention mattress, and one participant and one nurse finishing the study, using the control mattress.

    Potential benefits

    Main benefits

    Skin health

    Additional benefits

    General health

    Mental health

    Pain

    Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more

    • Trial recruitment status
    • Ended
    • Trial start date
    • 14 Sep 2021
    • Organisation
    • Sunnaas Rehabilitation Hospital
    • Trial recruitment status
    • Ended
    • Trial start date
    • 14 Sep 2021
    • Organisation
    • Sunnaas Rehabilitation Hospital

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more