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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06294327
Enrollment
621
Registered
2024-03-05
Start date
2024-01-22
Completion date
2026-07-24
Last updated
2026-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Decubitus Ulcer, Pressure Injury, Pressure Ulcer

Brief summary

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.

Interventions

DEVICEReactive static air support surfaces

* Repose® Mattress * Repose® Cushion * Repose® Wedge * Repose® Foot Protectors

Sponsors

Vitaz
Lead SponsorOTHER
University Ghent
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of pressure ulcer, category > IAfter admissionDevelopment of a pressure ulcer category \> I

Secondary

MeasureTime frameDescription
Cost of alternating air pressure mattress compared to reactive static air support surfacesAfter admissionEconomic cost (€)
Patient comfortAfter admissionTo 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')

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 28, 2026