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BMJ 2006;332:1413 (17 June), doi:10.1136/bmj.38849.478299.7C (published 1 June 2006)
Jane Nixon, deputy director1, Gillian Cranny, research fellow2, Cynthia Iglesias, research fellow3, E Andrea Nelson, reader4, Kim Hawkins, assistant director (statistics)1, Angela Phillips, senior trial coordinator1, David Torgerson, professor3, Su Mason, principal research fellow1, Nicky Cullum, professor3, PRESSURE Trial Group
1 Clinical Trials Research Unit, University of Leeds, 2 Centre for Reviews and Dissemination, University of York, 3 Department of Health Sciences, University of York, York YO10 5DD, 4 School of Healthcare Studies, University of Leeds
Correspondence to: N Cullum nac2{at}york.ac.uk
Objective To compare whether differences exist between alternating pressure overlays and alternating pressure mattresses in the development of new pressure ulcers, healing of existing pressure ulcers, and patient acceptability.
Design Pragmatic, open, multicentre, randomised controlled trial.
Setting 11 hospitals in six NHS trusts.
Participants 1972 people admitted to hospital as acute or elective patients.
Interventions Participants were randomised to an alternating pressure mattress (n = 982) or an alternating pressure overlay (n = 990).
Main outcome measures The proportion of participants developing a new pressure ulcer of grade 2 or worse; time to development of new pressure ulcers; proportions of participants developing a new ulcer within 30 days; healing of existing pressure ulcers; and patient acceptability.
Results Intention to treat analysis found no difference in the proportions of participants developing a new pressure ulcer of grade 2 or worse (10.7% overlay patients, 10.3% mattress patients; difference 0.4%, 95% confidence interval - 2.3% to 3.1%, P = 0.75). More overlay patients requested change owing to dissatisfaction (23.3%) than mattress patients (18.9%, P = 0.02).
Conclusion No difference was found between alternating pressure mattresses and alternating pressure overlays in the proportion of people who develop a pressure ulcer.
Trial registration ISRCTN 78646179
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