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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

308 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-22

Study Completion Date

2025-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

What is the Incidence of Pressure Ulcer Category II-IV (Including Deep-tissue Injury and Unstageable) on a Static Air Foam Hybrid Mattress?

NCT05142878

Pressure Ulcer Pressure Injury Pressure Sore +1 more

COMPLETED NA

Pressure Ulcer Prevention: a Turn and Positioning System Combined With Incontinence Care and Tailored/Standard Repositioning

NCT02690753

Pressure Ulcers Incontinence-associated Dermatitis

COMPLETED NA

Effects of Different Support Surfaces on the Properties Skin After Loading

NCT02930590

Pressure Ulcers

COMPLETED NA

Pressure Ulcer Incidence Cat. II+ on a Static Air Mattress: a Multicenter Cohort Study in Nursing Home Residents at Risk

NCT03725787

Pressure Ulcer Pressure Injury Pressure Sore +1 more

COMPLETED NA

Prevention of Pressure Ulcers in Patients at Medium to High Risk of Pressure Ulcers Using the R'GO SOINS Overlay Mattress

NCT06465225

Pressure Ulcer

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pressure Injury Pressure Ulcer Decubitus Ulcer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Reactive static air support surfaces (Repose®)

Intervention with Repose® devices

Standard repositioning protocol is applied.

Group Type EXPERIMENTAL

Reactive static air support surfaces

Intervention Type DEVICE

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

Alternating air pressure mattress (ArjoHuntleigh® Alpha Response)

Standard care with mattress type: ArjoHuntleigh® Alpha Response

Standard repositioning protocol is applied.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Reactive static air support surfaces

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

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Repose® devices

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes