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Completed
NCT06294327
RESTART the Prevention of Pressure Ulcers: Comparing the Effectiveness and Cost of a Reactive Static Air Mattress and Alternating Air Pressure Mattress
Conditions: Pressure Injury, Pressure Ulcer, Decubitus Ulcer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 621
Sponsor: Vitaz
Location: Vitaz (General Hospital) Sint-Niklaas East Flanders
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT06294327). StuddyBuddy aggregates publicly available trial information.