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

Pressure Ulcer Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06294327
• Other study ID #: EC23027
• Status: Recruiting
• Phase: N/A
• Start date: January 22, 2024
• Est. completion date: April 30, 2025

Study information

• Verified date: March 2024
• Source: Vitaz
• Contact: Dimitri Beeckman, Prof.
• Phone: +3237602039
• Email: Dimitri.Beeckman[@]UGent.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 308
• Est. completion date: April 30, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crush Injuries
• Decubitus Ulcer
• Pressure Injury
• Pressure Ulcer
• Ulcer

Intervention

Device:
• Reactive static air support surfaces
Repose® Mattress Repose® Cushion Repose® Wedge Repose® Foot Protectors

Locations

Country	Name	City	State
Belgium	Vitaz (General Hospital)	Sint-Niklaas	East Flanders

Sponsors (2)

Lead Sponsor	Collaborator
Vitaz	University Ghent

Country where clinical trial is conducted

Belgium, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of pressure ulcer, category > I	Development of a pressure ulcer category > I	After admission
Secondary	Cost of alternating air pressure mattress compared to reactive static air support surfaces	Economic cost (€)	After admission
Secondary	Patient comfort	To 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')	After admission

External Links

•   SKIN INTEGRITY RESEARCH GROUP (SKINT)
•   Study location; VITAZ (general) Hospital and Health Care VITAZ, Moerlandstraat 1, B-9100 Sint-Niklaas Belgium
•   University