RESTART the Prevention of Pressure Ulcers: Comparing the Effectiveness and Cost of a Reactive Static Air Mattress and Alternating Air Pressure Mattress

March 5, 2024 updated by: Vitaz

Comparing a REactive STatic Air Mattress to an Alternating Air Pressure Mattress in the Prevention of Pressure Ulcers: a Randomized Controlled Trial (RESTART)

Pressure ulcers are a global issue and substantial concern for healthcare systems. A review of the literature between January 2000 and December 2012 has revealed that prevalence rate of pressure ulcers in aged care facilities were between 4.1% and 32.2%, and the incidence rates ranged from 1.9% to 59%. Similarly, a systematic review reported that the prevalence of pressure ulcer varied between 0.3% and 46%, and the incidence of pressure ulcer ranged from 0.8% to 34%. Most epidemiological data were obtained from hospitals (38.7%) and institutional long-term care facilities (29.7%).

The costs associated with pressure ulcers are considerable. According to the Agency for Healthcare Research & Quality (2011), the US healthcare system has allocated approximately $ 9.1 - $ 11.6 billion annually for the health care cost of pressure ulcer. In addition to direct treatment-related costs, the development of pressure ulcer also results in litigation and government penalties, and affects hospital performance metrics. A systematic review has reported that the cost for treatment of pressure ulcer was higher than its prevention. That is, the cost per patient per day ranged from € 1.71 to € 470.49 (for treatment) and from € 2.65 to € 87.57 (for prevention) across all settings.

This randomized controlled trial will be performed in a general hospital in a random sample of 308 patients (nursing wards geriatric n=3 and orthopedic (n=3)) who are at high risk of developing pressure ulcers. Patients will be included in the study for a period > 2 hospitalisation days. Skin assessment and risk factor registration will be done on a daily base by the ward nurses. Reliability checks and time measurements will be completed by the researcher.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

308

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 Contact

Study Locations

  • Belgium
    • East Flanders
      • Sint-Niklaas, East Flanders, Belgium, 9100
        • Recruiting
        • Vitaz (General Hospital)
        • Contact:
        • Contact:
          • Peter Desmet, MD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Norton score < 14
  • Bed and/or chairfast
  • no pressure ulcers or at least pressure ulcer category I

Exclusion Criteria:

  • Norton Score >/=14
  • Pressure ulcers category II, III, IV, deep tissue injury (DTI) or unstageable pressure ulcer
  • Expected length of hospital stay < 2 days
  • Medical contraindication for use of reactive static air support surfaces
  • End of life care (or Do Not Reanimate (DNR) code IV)
  • Age < 18 years

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Reactive static air support surfaces (Repose®)

Intervention with Repose® devices

Standard repositioning protocol is applied.
Device: Reactive static air support surfaces
  • Repose® Mattress
  • Repose® Cushion
  • Repose® Wedge
  • Repose® Foot Protectors
Other Names:
  • Repose® devices
No Intervention: Alternating air pressure mattress (ArjoHuntleigh® Alpha Response)

Standard care with mattress type: ArjoHuntleigh® Alpha Response

Standard repositioning protocol is applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of pressure ulcer, category > I
Time Frame: After admission
Development of a pressure ulcer category > I
After admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost of alternating air pressure mattress compared to reactive static air support surfaces
Time Frame: After admission
Economic cost (€)
After admission
Patient comfort
Time Frame: After admission
To measure the degree of comfort a five point Likert scale was used (1 - 'not comfortable at all', 2 - 'not very comfortable', 3 - 'more or less comfortable', 4 - 'very comfortable', and 5 - 'totally comfortable')
After admission

Collaborators and Investigators

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

Sponsor

Vitaz

Collaborators

University Ghent

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)

January 22, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

February 27, 2024

First Submitted That Met QC Criteria

February 27, 2024

First Posted (Actual)

March 5, 2024

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC23027

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.

Clinical Trials on Pressure Ulcer

Clinical Trials on Reactive static air support surfaces

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Spain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe