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

May 3, 2021 updated by: University Ghent

Pressure Ulcer Incidence Cat. II+ on the CuroCell SAM® PRO 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Oost-Vlaanderen
      • Deinze, Oost-Vlaanderen, Belgium, 9800
        • WZC Sint-Vincentius
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • WZC Sint-Jozef
      • Kaprijke, Oost-Vlaanderen, Belgium, 9970
        • WZC Sint-Vincentius
      • Mariakerke, Oost-Vlaanderen, Belgium, 9030
        • WZC Brugse Vaart
      • Merelbeke, Oost-Vlaanderen, Belgium, 9820
        • Provinciaal Zorgcentrum Lemberge
      • Ursel, Oost-Vlaanderen, Belgium, 9910
        • WZC Onderdale
      • Wondelgem, Oost-Vlaanderen, Belgium, 9032
        • Residentie Vroonstalle
    • Vlaams-Brabant
      • Liedekerke, Vlaams-Brabant, Belgium, 1770
        • WZC Sint-Rafaël

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CuroCell S.A.M. ® pro mattress
Mattresses of eligible participants will be replaced by a static air pressure redistribution mattress (CuroCell S.A.M. ® Pro).
Device: CuroCell S.A.M. ® pro mattress
During 30 days, participants will use the static air mattress.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days
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
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Ghent

Collaborators

Care of Sweden

Investigators

  • Principal Investigator: Dimitri Beeckman, Phd, Study Principal Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 4, 2018

Primary Completion (ACTUAL)

February 6, 2019

Study Completion (ACTUAL)

October 6, 2020

Study Registration Dates

First Submitted

October 25, 2018

First Submitted That Met QC Criteria

October 30, 2018

First Posted (ACTUAL)

October 31, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 6, 2021

Last Update Submitted That Met QC Criteria

May 3, 2021

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC/2018/0091
  • B670201835095 (OTHER: Ethics Committee UZ Gent)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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