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

Not Applicable

Recruiting

• Conditions: Pressure Injury; Pressure Ulcer; Decubitus Ulcer
• Interventions: Device: Reactive static air support surfaces

• Registration Number: NCT06294327
• Lead Sponsor: Vitaz

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-22
• Study First Submitted: 2024-02-27
• Study First Submitted QC: 2024-02-27
• Status Verified: 2024-03
• Study First Posted: 2024-03-05
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-07
• Primary Completion: 2025-01-01
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 308

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reactive static air support surfaces (Repose®)	Reactive static air support surfaces	Intervention with Repose® devices Standard repositioning protocol is applied.

Primary Outcome Measures

Name	Time	Method
Incidence of pressure ulcer, category > I	After admission	Development of a pressure ulcer category \> I

Secondary Outcome Measures

Name	Time	Method
Cost of alternating air pressure mattress compared to reactive static air support surfaces	After admission	Economic cost (€)
Patient comfort	After admission	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')

Trial Locations

Locations (1)

Vitaz (General Hospital); 🇧🇪 Sint-Niklaas, East Flanders, Belgium