The DEXACELL Trial
  • The DEXACELL Trial

    (DEXAmethasone in CELLulitis)

    Background

    What research question are we are trying to answer?
    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 antibiotic usage and healthcare use?

    Why is this an important question to answer?
    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 (1). When patients with cellulitis attend hospital they are usually treated with antibiotics and painkillers (2). However, even with this treatment around 1 in 5 patients will later seek further treatment due to ongoing symptoms – most often this is due to pain. This can lead to additional doctors appointments, A&E visits and additional antibiotics (3). It is therefore important to look for other ways to reduce early symptoms in patients with cellulitis, particularly pain.

    There is a type of anti-inflammatory medicine called ‘corticosteroids’ that are often given to reduce inflammation and pain, improving short-term symptoms in patients with other types of infection and many other conditions. They are not currently used for the treatment of cellulitis but small research studies suggest that the addition of oral corticosteroids to antibiotics reduces pain and other symptoms, without adverse effects (4-6). Because of this, some guideline bodies recommend corticosteroids in patients with cellulitis, while others suggest further trial data is needed. A definitive clinical trial is needed to establish the costs and benefits of giving corticosteroids to patients with cellulitis by assessing outcomes that matter to patients and the health service.

    We are therefore running this large trial across multiple hospitals across England and Wales. We are aiming to recruit 450 patients to participate in the trial so that we can find out whether giving people with cellulitis a ‘corticosteroid’ called dexamethasone can:

    • Reduce pain,
    • Improve quality of life,
    • Reduce additional healthcare appointments,
    • Reduce the need for extra antibiotics and pain relief,
    • Reduce costs.

    References:
    (1)   Haydock SF, Bornshin S, Wall EC, Connick RM. Admissions to a U.K. teaching hospital with nonnecrotizing lower limb cellulitis show a marked seasonal variation. Br J Dermatol [Internet] 2007;157(5):1047–8. Available from: http://dx.doi.org/10.1111/j.1365-2133.2007.08124.x
    (2)   Recommendations | Cellulitis and erysipelas: antimicrobial prescribing | Guidance | NICE. [cited 2023 May 22];Available from: https://www.nice.org.uk/guidance/ng141/chapter/Recommendations
    (3)   Obaitan I, Dwyer R, Lipworth AD, et al. Failure of antibiotics in cellulitis trials: a systematic review and meta-analysis. Am J Emerg Med [Internet] 2016;34(8):1645–52. Available from: http://dx.doi.org/10.1016/j.ajem.2016.05.064
    (4) Bergkvist PI, Sjöbeck K. Antibiotic and prednisolone therapy of erysipelas: a randomized, double blind, placebo-controlled study. Scand J Infect Dis [Internet] 1997;29(4):377–82. Available from: http://dx.doi.org/10.3109/00365549709011834
    (5) Bergkvist PI, Sjöbeck K. Relapse of erysipelas following treatment with prednisolone or placebo in addition to antibiotics: a 1-year follow-up. Scand J Infect Dis [Internet] 1998;30(2):206–7. Available from: http://dx.doi.org/10.1080/003655498750003708
    (6) Use of a Single Dose of Oral Prednisone in the Treatment of Cellulitis [Internet]. [cited 2023 May 22];Available from: https://clinicaltrials.gov/ct2/show/NCT01671423