title: Pressure RElieving Support SUrfaces: a Randomised Evaluation 2 (PRESSURE 2): study protocol for a randomised controlled trial.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK. medsbro@leeds.ac.uk.
authors.forename: Sarah
authors.identifier: 0000-0002-1840-3786
authors.initials: S
authors.lastname: Brown
authors.affiliation: Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.
authors.forename: Isabelle L
authors.initials: IL
authors.lastname: Smith
authors.affiliation: Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.
authors.forename: Julia M
authors.initials: JM
authors.lastname: Brown
authors.affiliation: Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, LS2 9JT, UK.
authors.forename: Claire
authors.initials: C
authors.lastname: Hulme
authors.affiliation: Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.|Leeds Teaching Hospitals NHS Trust, Leeds, LS9 7TF, UK.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: McGinnis
authors.affiliation: Leeds Community Healthcare NHS Trust St Mary's Hospital, Leeds, LS12 3QE, UK.
authors.forename: Nikki
authors.initials: N
authors.lastname: Stubbs
authors.affiliation: School of Healthcare, University of Leeds, Leeds, LS2 9JT, UK.
authors.forename: E Andrea
authors.initials: EA
authors.lastname: Nelson
authors.affiliation: Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.
authors.forename: Delia
authors.initials: D
authors.lastname: Muir
authors.affiliation: Quality of Life Office, Psycho-oncology Co-operative Research Group, School of Psychology, University of Sydney, Level 6 North, Chris O'Brien Lifehouse (C39Z), Sydney, NSW, Australia.
authors.forename: Claudia
authors.initials: C
authors.lastname: Rutherford
authors.affiliation: Pressure Ulcer Research Service User Network, Leeds, LS2 9JT, UK.
authors.forename: Kay
authors.initials: K
authors.lastname: Walker
authors.affiliation: Northumbria Healthcare NHS Foundation Trust, North Shields, NE29 8NH, UK.
authors.forename: Valerie
authors.initials: V
authors.lastname: Henderson
authors.affiliation: Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.|Mid Yorkshire Hospitals NHS Trust, Dewsbury, WF13 2, UK.
authors.forename: Lyn
authors.initials: L
authors.lastname: Wilson
authors.affiliation: Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.
authors.forename: Rachael
authors.initials: R
authors.lastname: Gilberts
authors.affiliation: Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.
authors.forename: Howard
authors.initials: H
authors.lastname: Collier
authors.affiliation: Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.
authors.forename: Catherine
authors.initials: C
authors.lastname: Fernandez
authors.affiliation: Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.
authors.forename: Suzanne
authors.initials: S
authors.lastname: Hartley
authors.affiliation: Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.
authors.forename: Moninder
authors.initials: M
authors.lastname: Bhogal
authors.affiliation: Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.
authors.forename: Susanne
authors.initials: S
authors.lastname: Coleman
authors.affiliation: Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.
authors.forename: Jane E
authors.initials: JE
authors.lastname: Nixon
mesh_terms: D001513:Beds / Q000191:economics; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D004867:Equipment Design; D017721:Hospital Costs; D006801:Humans; D010781:Photography; D011312:Pressure; D003668:Pressure Ulcer / Q000191:economics / Q000473:pathology / Q000503:physiopathology / Q000628:therapy*; D011788:Quality of Life; D012107:Research Design; D013222:State Medicine; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom; D014945:Wound Healing
keywords: Alternating pressure mattress; Double triangular group sequential design; Pressure ulcers; Quality of life; Randomised controlled trial; Standard foam mattress