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NCT Number: NCT06294327

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vitaz (General Hospital)

Sint-Niklaas, East Flanders, 9100, Belgium

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Reactive static air support surfaces

Device
  • Repose® Mattress
  • Repose® Cushion
  • Repose® Wedge
  • Repose® Foot Protectors

Other names: Repose® devices

Primary outcomes

  1. Incidence of pressure ulcer, category > I

    Time frame: After admission

    Development of a pressure ulcer category > I

Secondary outcomes

  1. Cost of alternating air pressure mattress compared to reactive static air support surfaces

    Time frame: After admission

    Economic cost (€)

  2. 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')

Sponsors and collaborators

Lead sponsor

Vitaz

Other

Collaborators

  • University Ghent

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Mar 5, 2024
Registry last updated
Jul 27, 2026

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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