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

Vitaz

Status

Enrolling

Conditions

Pressure Ulcer

Pressure Injury

Decubitus Ulcer

Treatments

Device: Reactive static air support surfaces

Study type

Interventional

Funder types

Other

Identifiers

NCT06294327

EC23027

Details and patient eligibility

About

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.

Enrollment

308 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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