Clinical trial NCT06294327: RESTART the Prevention of Pressure Ulcers: Comparing the Effectiveness and Cost of a Reactive Static Air Mattress and Alternating Air Pressure Mattress
Official title: Comparing a REactive STatic Air Mattress to an Alternating Air Pressure Mattress in the Prevention of Pressure Ulcers: a Randomized Controlled Trial (RESTART)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pressure Injury
Pressure Ulcer
Decubitus Ulcer
Lead sponsor: Vitaz
Sponsor class: OTHER
Collaborators: name: University Ghent
First posted: 2024-03-05
Enrollment: 308
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Incidence of pressure ulcer, category > I
timeFrame: After admission
Secondary outcomes:
measure: Cost of alternating air pressure mattress compared to reactive static air support surfaces
timeFrame: After admission
measure: Patient comfort
timeFrame: After admission
Other outcomes:
Locations:
city: Sint-Niklaas
country: Belgium
facility: Vitaz (General Hospital)
state: East Flanders
Study officials:
References:
citation: Anrys C, Van Tiggelen H, Verhaeghe S, Van Hecke A, Beeckman D. Independent risk factors for pressure ulcer development in a high-risk nursing home population receiving evidence-based pressure ulcer prevention: Results from a study in 26 nursing homes in Belgium. Int Wound J. 2019 Apr;16(2):325-333. doi: 10.1111/iwj.13032. Epub 2018 Nov 9.
citation: Shi C, Dumville JC, Cullum N, Rhodes S, Leung V, McInnes E. Reactive air surfaces for preventing pressure ulcers. Cochrane Database Syst Rev. 2021 May 7;5(5):CD013622. doi: 10.1002/14651858.CD013622.pub2.
citation: Beeckman D, Serraes B, Anrys C, Van Tiggelen H, Van Hecke A, Verhaeghe S. A multicentre prospective randomised controlled clinical trial comparing the effectiveness and cost of a static air mattress and alternating air pressure mattress to prevent pressure ulcers in nursing home residents. Int J Nurs Stud. 2019 Sep;97:105-113. doi: 10.1016/j.ijnurstu.2019.05.015. Epub 2019 Jun 8.
citation: Serraes B, van Leen M, Schols J, Van Hecke A, Verhaeghe S, Beeckman D. Prevention of pressure ulcers with a static air support surface: A systematic review. Int Wound J. 2018 Jun;15(3):333-343. doi: 10.1111/iwj.12870. Epub 2018 Mar 5.