A randomised controlled trial to compare the effectiveness of high specification foam and alternating pressure mattresses in pressure ulcer prevention.
Background: Pressure Ulcers (PUs) represent a major burden to patients, carers and the healthcare system, affecting approximately 1 in 10 hospital and 1 in 20 community patients. They impact greatly on the physical, social and psychological wellbeing of patients and are estimated to cost £1.4-2.1 billion annually, equivalent to 4% of NHS expenditure. There are two types of mattresses in use within the NHS high specification foam (HSF) which is classed as low tech and alternating pressure mattresses (APMs) which are classed as high tech and are much more expensive. Despite both mattresses being widely used, there is no evidence which is best at preventing PUs. In light of this, we are undertaking a randomised controlled trial to compare HSF and APMs in a high risk in-patient population.
Aim: The aim of this study is to determine the clinical and cost effectiveness of HSF and APMs for the prevention of Category 2 (and above) PUs when used in conjunction with an electric profiling bed frame for patients with evidence of acute illness in secondary and community in-patient facilities.
Primary objective: To compare the time to develop a new Category 2 or above PU in patients using HSF to those using APM by 30 days after the end of treatment phase.
1. To compare the time to develop a new category 3 or above PU in patients using HSF and those using APM.
2. To compare the time to develop a new category 1 or above PU in patients using HSF and those using APM.
3. To compare the time to heal pre-existing Category 2 PUs in patients using HSF and those using APM.
4. To determine the impact of HSF and APM on health related quality of life.
5. To determine the incremental cost-effectiveness of APM compared to HSF from the perspective of the health and social care sectors.
6. To compare incidence of mattress change between patients using HSF and those using APM.
7. To compare safety between patients using HSF and those using APM
Design: A multicentre, open, randomised, double triangular sequential, parallel group trial, with two planned interim analyses. Patients will be randomised on a 1:1 basis to either HSF or APM in conjunction with an electric profiling bed frame. Patients will be assessed twice weekly from randomisation until 30 days, then once weekly up to 60 days or until patient is discharged from hospital. A post treatment follow up visit will be conducted 30 days after the end of the treatment phase.
Sample Size: The maximum number of patients required will be 2954 recruited over a 3 year period; however, interim analyses will be conducted once recruitment reaches approximately 1506 and 2236 patients and an assessment made on whether the trial should continue. The sequential trial design will allow early termination by demonstrating effectiveness of either mattress or futility of the trial.
Study Status: Open to recruitment (until May 2016)
Chief Investigator: Professor Jane Nixon, Clinical Trials Research Unit, University of Leeds
0113 343 4854
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