Pressure relieving support surfaces for pressure ulcer prevention (PRESSURE 2): clinical and health economic results of a randomised controlled trial
Nixon, J; Smith, I; Brown, S; et al.McGinnis, E; Vargas-Palacios, A; Nelson, EA; Coleman, S; Collier, H; Fernandez, C; Gilberts, R; Henderson, V; Muir, D; Stubbs, N; Walker, K; Wilson, L; Hulme, C
Date: 3 September 2019
Journal
Lancet
Publisher
Elsevier
Publisher DOI
Abstract
Background
Pressure ulcers (PUs) are complications of serious acute/chronic illness. Specialist mattresses
used for prevention lack high quality effectiveness evidence. We aimed to compare clinical
and cost effectiveness of 2 mattress types.
Methods
Multicentre, Phase III, open, prospective, parallel group, randomised, controlled ...
Background
Pressure ulcers (PUs) are complications of serious acute/chronic illness. Specialist mattresses
used for prevention lack high quality effectiveness evidence. We aimed to compare clinical
and cost effectiveness of 2 mattress types.
Methods
Multicentre, Phase III, open, prospective, parallel group, randomised, controlled trial in 42
UK secondary/community in-patient facilities.
2029 high risk (acutely ill, bedfast/chairfast and/or Category 1 PU/pain at PU site) adult inpatients were randomised (1:1, allocation concealment, minimisation with random element)
factors including: centre, PU status, facility and consent type. Interventions were alternating
pressure mattresses (APMs) or high specification foam (HSF) for maximum treatment phase
60 days. Primary outcome was time to development of new PU Category≥2 from
randomisation to 30 day post-treatment follow-up in intention-to treat population. Trial
registration: ISRCTN 01151335
Findings:
Between August 2013 and November 2016, we randomised 2029 patients (1016 APMs: 1013
HSF) who developed 160(7.9%) PUs. There was insufficient evidence of a difference between
groups for time to new PU Category≥2 Fine and Gray Model Hazard Ratio HR=0.76,
95%CI0.56-1.04); exact P=0.0890; absolute difference 2%). There was a statistically
significant difference in the treatment phase time to event sensitivity analysis, Fine and Gray
model HR=0.66, 95%CI, 0.46-0.93; exact P=0.0176); 2.6% absolute difference). Economic
analyses indicates that APM are cost-effective.
There were no safety concerns.
Interpretation:
In high risk (acutely ill, bedfast/chairfast/Category 1 PU/ pain on a PU site) in-patients, we
found insufficient evidence of a difference in time to PU development at 30-day final followup, which may be related to a low event rate affecting trial power. APMs conferred a small
treatment phase benefit. Patient preference, low PU incidence and small group differences
suggests the need for improved targeting of APMs with decision making informed by patient
preference/comfort/rehabilitation needs and the presence of potentially modifiable risk
factors such as being completely immobile, nutritional deficits, lacking capacity and/or
altered skin/Category1 PU.
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Except where otherwise noted, this item's licence is described as © 2019 Published by Elsevier Ltd. This is an open access article under the CC BY-NC-ND license (http://
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