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NCT Number: NCT03725787

Pressure Ulcer Incidence Cat. II+ on a Static Air Mattress: a Multicenter Cohort Study in Nursing Home Residents at Risk

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.

Static or reactive overlay mattresses are an example of a low-tech constant low-pressure support. Static air mattresses maintain a continuous low air pressure that exerts a pressure redistributing effect. Serraes and Beeckman found a pressure ulcer incidence of 5.1% in patients placed on static air support (mattress overlay, heel wedge and seat cushion) in a high risk population in a nursing home setting in Belgium.

The CuroCell SAM PRO (Care of Sweden AB) is a static air mattress overlay system used as prevent and treat pressure ulcers (up to category 3) and for pain therapy. The aim of current study is to measure pressure ulcer incidence on the CuroCell Sam PRO static air mattress in nursing home residents at risk for pressure ulcer development over a 30-day period in Belgium.

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Key information

Conditions

Pressure Ulcer Bed Sore Pressure Injury Pressure Sore Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

WZC Sint-Vincentius, Deinze, Oost-Vlaanderen, Belgium

Loading trial locations.

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
  • 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
  • Pressure ulcer Cat. II+ present on initial evaluation

Treatment and study plan

CuroCell S.A.M. ® pro mattress

Device

During 30 days, participants will use the static air mattress.

Primary outcomes

  1. Pressure ulcer incidence (Cat. II+), (NPUAP classification system)

    Time frame: 30 days

    Development of at least 1 pressure ulcer Cat. II+ during study period, not associated with the use of medical devices

Secondary outcomes

  1. Incidence rate of Cat. I pressure ulcers, (NPUAP classification system)

    Time frame: 30 days

    Development of at least 1 pressure ulcer Cat. I during study period, not associated with the use of medical devices

  2. Comfort of participants (self developed questionnaire)

    Time frame: 30 days

    A quantitative approach to obtain insight in residents' experiences and perceptions of comfort by using a questionnaire

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Collaborators

  • Care of Sweden

Registry information

Official study title

Pressure Ulcer Incidence Cat. II+ on the CuroCell SAM® PRO Static Air Mattress: a Multicenter Cohort Study in Nursing Home Residents at Risk

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Oct 31, 2018
Registry last updated
May 6, 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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