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Pressure RElieving Support SUrfaces: a Randomised Evaluation 2 (PRESSURE 2): study protocol for a randomised

Sarah Brown¹, Isabelle L Smith², Julia M Brown²

¹Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK. medsbro@leeds.ac.uk.

|December 21, 2016

Summary

This summary is machine-generated.

The PRESSURE 2 study compares high-specification foam and alternating pressure mattresses for preventing pressure ulcers in high-risk patients. This trial aims to determine which mattress type offers superior protection against pressure ulcer development.

Keywords:

Alternating pressure mattress Double triangular group sequential design Pressure ulcers Quality of life Randomised controlled trial Standard foam mattress

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Area of Science:

Clinical Medicine
Nursing Research
Healthcare Technology

Background:

Pressure ulcers are a significant burden on patients, carers, and healthcare systems, affecting numerous hospital and community patients.
These ulcers severely impact patient functional status and quality of life.
Current prevention strategies include specialized support surfaces and patient repositioning.

Purpose of the Study:

To compare the effectiveness of high-specification foam mattresses versus alternating pressure mattresses in preventing pressure ulcers.
To evaluate the time to developing new pressure ulcers (Category 2 or above) within 30 days post-treatment.
To assess secondary outcomes including ulcer healing, quality of life, cost-effectiveness, and safety.

Main Methods:

A multicenter, randomized, parallel-group trial (PRESSURE 2) involving up to 2954 high-risk patients.
Patients were randomized 1:1 to receive either a high-specification foam or an alternating pressure mattress.
A double triangular, group sequential design was employed for efficient data analysis and potential early stopping.

Main Results:

The study is designed to efficiently compare two common mattress types for pressure ulcer prevention.
It aims to provide robust clinical evidence on mattress effectiveness.
Results will inform clinical practice and patient care by identifying superior prevention methods.

Conclusions:

The PRESSURE 2 trial employs an efficient design to yield timely evidence on pressure ulcer prevention.
Findings will guide the selection of optimal support surfaces in healthcare settings.
This research seeks to reduce the incidence and impact of pressure ulcers.