A simple course of steroid tablets could cut pain and antibiotic use for the 20% of cellulitis patients who remain sick after initial treatment. Cellulitis, a common bacterial skin infection, costs the NHS in England and Wales an estimated £220 million per year in hospital treatment alone. Despite standard antibiotics, roughly one in five patients still experiences significant pain and often requires additional healthcare visits, prolonged antibiotics, or a switch to intravenous drugs—even though evidence for this escalation is weak. Small trials suggest that adding oral corticosteroids like dexamethasone to antibiotics reduces symptoms without harm, but current guidelines disagree, and a recent Cochrane review called for more data. This trial will randomise 450 adults across 15 urgent care sites to receive either two 8mg doses of dexamethasone or a placebo alongside usual antibiotics. If the steroid proves effective, it could become a cheap, widely available addition to standard care—reducing patient suffering, cutting unnecessary antibiotic use, and saving the NHS millions in avoidable hospital visits and intravenous treatments.
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Research question Is the addition of oral dexamethasone to usual care in patients who present to urgent and emergency care with cellulitis effective and cost-effective in terms of reducing pain, improving quality of life, and reducing further antimicrobial usage and healthcare utilisation? Background Cellulitis is a common bacterial skin infection and has a major impact on patients and healthcare utilisation. Hospital treatment costs in England and Wales alone are estimated at £220 million per year. Despite initial oral antibiotic therapy, ~20% of patients have continued pain and other symptoms. This often leads to further healthcare visits with prolonged antibiotic use or a switch to intravenous antibiotics, despite lack of evidence for benefit. Small randomised trials suggest that addition of oral corticosteroids to antibiotics reduces pain and other symptoms, without adverse effects. Because of this, some guideline bodies recommend corticosteroids in patients with cellulitis, while others (and a recent Cochrane review) suggest further trial data is needed. To establish the costs and benefits of corticosteroids in cellulitis, assessing outcomes that matter to patients and the health service, a definitive trial is needed. Aims and objectives Aim: To evaluate the effectiveness and cost-effectiveness of the addition of oral dexamethasone to usual care in patients who present to urgent and emergency care with cellulitis in terms of reducing pain, improving quality of life, and reducing further antimicrobial usage and healthcare utilisation. Objectives: To establish if the addition of dexamethasone: a) reduces total pain over the first 3 days b) improves quality of life and other patient reported outcomes c) reduces subsequent antimicrobial prescribing and healthcare utilisation d) is more cost-effective than usual care Methods Pragmatic, multi-centre, double-blind, placebo-controlled, randomised, parallel group superiority trial, with internal pilot and parallel health economic evaluation, in ~15 urgent and emergency care settings. 450 consenting adults with cellulitis will be randomised to a) oral dexamethasone 8mg immediately and 8mg 24 hours later or b) matched placebo. All participants will also receive standard care including antibiotics. The primary outcome is total pain experienced over the first 3 days. Pain scores will be captured twice daily using a numerical rating scale (NRS; scored between 0-100) and used to calculate the standardised area under the curve. Secondary outcomes include other patient reported outcomes, antibiotic usage (by day 14), health, social care and broader societal resource use and cellulitis recurrence (by day 90). Timelines for delivery (months) Trial set-up (1-8), including internal pilot (n=10) sites (5-8); Pilot recruitment: (9-14); All sites (n=15) recruitment: (15-25), Final follow-up: (26-29); Analysis, dissemination: (30-36). Impact and dissemination We will publish our primary results in a high impact medical journal and present our findings at multiple conferences. We will communicate our findings to the Royal College of Emergency Medicine, Society for Acute Medicine, NICE and NHS England to incorporate our work into relevant guidelines. We will work with our patient advisory group and with advice from the NIHR Centre for Engagement and Dissemination to disseminate findings in a way that is accessible to the public via social and traditional media, including infographics and video.
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