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Trials
Published in: Trials 1/2016

Open Access 01-12-2016 | Study protocol

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

Authors: Sarah Brown, Isabelle L. Smith, Julia M. Brown, Claire Hulme, Elizabeth McGinnis, Nikki Stubbs, E. Andrea Nelson, Delia Muir, Claudia Rutherford, Kay Walker, Valerie Henderson, Lyn Wilson, Rachael Gilberts, Howard Collier, Catherine Fernandez, Suzanne Hartley, Moninder Bhogal, Susanne Coleman, Jane E. Nixon

Published in: Trials | Issue 1/2016

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Abstract

Background

Pressure ulcers represent a major burden to patients, carers and the healthcare system, affecting approximately 1 in 17 hospital and 1 in 20 community patients. They impact greatly on an individual’s functional status and health-related quality of life. The mainstay of pressure ulcer prevention practice is the provision of pressure redistribution support surfaces and patient repositioning. The aim of the PRESSURE 2 study is to compare the two main mattress types utilised within the NHS: high-specification foam and alternating pressure mattresses, in the prevention of pressure ulcers.

Methods/Design

PRESSURE 2 is a multicentre, open-label, randomised, double triangular, group sequential, parallel group trial. A maximum of 2954 ‘high-risk’ patients with evidence of acute illness will be randomised on a 1:1 basis to receive either a high-specification foam mattress or alternating-pressure mattress in conjunction with an electric profiling bed frame. The primary objective of the trial is to compare mattresses in terms of the time to developing a new Category 2 or above pressure ulcer by 30 days post end of treatment phase. Secondary endpoints include time to developing new Category 1 and 3 or above pressure ulcers, time to healing of pre-existing Category 2 pressure ulcers, health-related quality of life, cost-effectiveness, incidence of mattress change and safety. Validation objectives are to determine the responsiveness of the Pressure Ulcer Quality of Life-Prevention instrument and the feasibility of having a blinded endpoint assessment using photography. The trial will have a maximum of three planned analyses with unequally spaced reviews at event-driven coherent cut-points. The futility boundaries are constructed as non-binding to allow a decision for stopping early to be overruled by the Data Monitoring and Ethics Committee.

Discussion

The double triangular, group sequential design of the PRESSURE 2 trial will provide an efficient design through the possibility of early stopping for demonstrating either superiority, inferiority of mattresses or futility of the trial. The trial optimises the potential for producing robust clinical evidence on the effectiveness of two commonly used mattresses in clinical practice earlier than in a conventional design.

Trial registration

ISRCTN01151335. Registered on 14 May 2013. Protocol version: 5.0, dated 25 September 2015
Trial sponsor: Clare Skinner, Faculty Head of Research Support, University of Leeds, Leeds, LS2 9JT; 0113 343 4897; C.E.Skinner@leeds.ac.uk.
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Metadata
Title
Pressure RElieving Support SUrfaces: a Randomised Evaluation 2 (PRESSURE 2): study protocol for a randomised controlled trial
Authors
Sarah Brown
Isabelle L. Smith
Julia M. Brown
Claire Hulme
Elizabeth McGinnis
Nikki Stubbs
E. Andrea Nelson
Delia Muir
Claudia Rutherford
Kay Walker
Valerie Henderson
Lyn Wilson
Rachael Gilberts
Howard Collier
Catherine Fernandez
Suzanne Hartley
Moninder Bhogal
Susanne Coleman
Jane E. Nixon
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1703-8

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