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Completed

NCT Number: NCT04890678

The Use of a Fully Automated Pulsating Support System (CuroCell® A4 CX20) in Pressure Ulcer Prevention and Treatment

Pressure Ulcers are a serious and common problem for residents admitted to long-term care facilities and community care patients. They represent a major burden to patients, carers and the Healthcare system, affecting approximately 1 in 20 community patients. International guidelines recommend the use of pressure redistribution support surfaces, systematic patient repositioning and preventive skin care to prevent pressure ulcers.

It has been acknowledged that a significant proportion of pressure ulcers are avoidable. The prevalence of pressure ulcers is 1 of the 4 common harms recorded in the UK NHS Safety Thermometer, a local improvement tool for measuring, monitoring and analyzing patient harms across a range of settings, including nursing homes, community nursing and hospitals on a monthly basis.

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Key information

Conditions

Pressure Ulcer Pressure Injury Pressure Sore Pressure Ulcer, Buttock Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

65 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

WZC Hof ter Waarbeek

Asse, Vlaams-Brabant, 1770, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At risk of pressure ulcer development based on a Braden score ≤ 17 or pressure ulcer category III or IV
  • Bedbound or chair bound
  • Aged ≥ 65

Exclusion criteria

  • Short-stay residents (expected length of stay ≤14 days)
  • End of life care
  • Medical contraindication for patient repositioning/turning

Treatment and study plan

22 residentsat risk for PU development

Device

mattress in bed

The presence of PUs will be evaluated using the European Pressure Ulcer Advisory Panel (EPUAP) classification system (NPUAP, 2014) and the presence of incontinence- associated dermatitis (IAD) will be categorized using the Ghent Global IAD Categorisation Tool (GLOBIAD). For each participant, the Patient Repositioning Tool Ghent (PROTECT) will be used to individually recommend the frequency of skin observations and the frequency of repositioning.

18 residents at least one PU category III-IV in the sacral area

Device

mattress in bed The presence of PUs will be evaluated using the European Pressure Ulcer Advisory Panel (EPUAP) classification system (NPUAP, 2014) and the presence of incontinence- associated dermatitis (IAD) will be categorized using the Ghent Global IAD Categorisation Tool (GLOBIAD). For each participant, the Patient Repositioning Tool Ghent (PROTECT) will be used to individually recommend the frequency of skin observations and the frequency of repositioning.

In the group of participants with a PU category III or IV, the Pressure Ulcer Scale for Healing Tool (PUSH) will be used to assess and measure change in PU status. The score on the PUSH-tool is defined by the surface area of the PU (length x width), the amount of exudate and the type of tissue in the wound bed.

Primary outcomes

  1. Pressure ulcer incidence

    Time frame: 30 days

    Development of at least 1 Pressure ulcer category II+ during study period using European Pressure Ulcer Advisory Panel (EPUAP) classification system

  2. Pressure ulcer healing

    Time frame: 30 days

    Healing of pressure ulcers category III and IV during the 30-day study period - using the Pressure Ulcer Scale for Healing Tool (PUSH)

Secondary outcomes

  1. Comfort

    Time frame: 30 days

    perceived comfort and experiences of users of the mattress - using self-developed questionnaire

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Collaborators

  • Care of Sweden AB

Registry information

Official study title

The Use of a Fully Automated Pulsating Support System (CuroCell® A4 CX20) in Pressure Ulcer Prevention and Treatment: a Clinical Test in 10 Belgian Nursing Homes

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 18, 2021
Registry last updated
May 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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