protocolSection identificationModule nctId: NCT06294327, orgStudyIdInfo id: EC23027, briefTitle: RESTART the Prevention of Pressure Ulcers: Comparing the Effectiveness and Cost of a Reactive Static Air Mattress and Alternating Air Pressure Mattress, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-22, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-04-30, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Vitaz, class: OTHER, collaborators name: University Ghent, descriptionModule briefSummary: 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., conditionsModule conditions: Pressure Injury, conditions: Pressure Ulcer, conditions: Decubitus Ulcer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 308, type: ESTIMATED, armsInterventionsModule interventions name: Reactive static air support surfaces, outcomesModule primaryOutcomes measure: Incidence of pressure ulcer, category > I, secondaryOutcomes measure: Cost of alternating air pressure mattress compared to reactive static air support surfaces, secondaryOutcomes measure: Patient comfort, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Vitaz (General Hospital), status: RECRUITING, city: Sint-Niklaas, state: East Flanders, zip: 9100, country: Belgium, contacts name: Brecht Serraes, PhD, role: CONTACT, phone: +3237602039, email: Brecht.Serraes@vitaz.be, contacts name: Peter Desmet, MD, role: CONTACT, geoPoint lat: 51.16509, lon: 4.1437, hasResults: False