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

NCT06294327 | Recruiting

• 1 other identifier: EC23027
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 1

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.

Conditions

Pressure Injury; Pressure Ulcer; Decubitus Ulcer

Outcome Measures

Primary Outcomes (1)

• Incidence of pressure ulcer, category > I

  Development of a pressure ulcer category \> I

  After admission

Secondary Outcomes (2)

• Cost of alternating air pressure mattress compared to reactive static air support surfaces

  After admission

• Patient comfort

  After admission

Study Arms (2)

Reactive static air support surfaces (Repose®)

EXPERIMENTAL

Intervention with Repose® devices Standard repositioning protocol is applied.

Device: Reactive static air support surfaces

Alternating air pressure mattress (ArjoHuntleigh® Alpha Response)

NO INTERVENTION

Standard care with mattress type: ArjoHuntleigh® Alpha Response Standard repositioning protocol is applied.

Interventions

Reactive static air support surfaces DEVICE

* Repose® Mattress * Repose® Cushion * Repose® Wedge * Repose® Foot Protectors

Also known as: Repose® devices

Reactive static air support surfaces (Repose®)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Norton score \< 14
• Bed and/or chairfast
• no pressure ulcers or at least pressure ulcer category I

You may not qualify if:

• 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

Sponsors & Collaborators

• Vitaz: lead
• University Ghent: collaborator

Study Sites (1)

Vitaz (General Hospital)

Sint-Niklaas, East Flanders, 9100, Belgium

RECRUITING

Related 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.

  PMID: 30412652 BACKGROUND

• 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.

  PMID: 33999463 BACKGROUND

• 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.

  PMID: 31234104 BACKGROUND

• 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.

  PMID: 29504266 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Dimitri Beeckman, Prof.

CONTACT

+3237602039; Dimitri.Beeckman@UGent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 5, 2024
• Study Start: January 22, 2024
• Primary Completion: January 1, 2025
• Study Completion: April 30, 2025
• Last Updated: March 7, 2024

Record last verified: 2024-03

Locations

BE (1)