The DEXACELL Trial

  • Research type

    Research Study

  • Full title

    DEXACELL: Dexamethasone as an adjunctive therapy for the management of cellulitis - a randomised controlled trial in urgent secondary care

  • IRAS ID

    1009877

  • Contact name

    Edward Carlton

  • Contact email

    ed.carlton@nbt.nhs.uk

  • Sponsor organisation

    North Bristol NHS Trust

  • ISRCTN Number

    ISRCTN76873478

  • Research summary

    Cellulitis is a common bacterial skin infection. Over 300,000 people attend emergency departments in the UK each year with cellulitis. Antibiotic treatment is always recommended to kill the bacteria causing infection but does not always improve symptoms. Symptoms often get worse after starting antibiotics, with pain and swelling increasing in the first few days. Around 1/5 people see a doctor again for further treatment. There is no evidence that giving out more antibiotics improves symptoms and using excess antibiotics will reduce their effectiveness for everyone (antibiotic resistance). Corticosteroid (“steroid”) tablets have been tried as an add-on treatment in a few small studies to reduce swelling, redness and pain. Results have been promising but the studies have been small and more research is needed to find out if steroid tablets work in cellulitis before advising clinicians to routinely use them.

    This is a large study to see if prescribing steroid tablets alongside antibiotics improves symptoms and reduces the need for further antibiotics and healthcare visits for patients with cellulitis. We will recruit 450 adult participants who come to an NHS emergency or urgent care department with cellulitis.

    After consent, participants will be put into one of two groups at random. One group will receive steroid (dexamethasone) capsules to take for 2 days, the other group will receive placebo capsules. Both groups will also get the normal treatment for cellulitis (antibiotics and painkillers). Neither the participants nor the clinicians will know which group they are in.

    We will ask participants about their pain twice a day for three days via electronic survey/text message or telephone call, if preferred. We will telephone participants after 14 days to ask about lingering pain, antibiotic and painkiller use and any other healthcare use and after 90 days to see if they have had cellulitis again.

    This study is funded by the NIHR HTA programme.

  • REC name

    South Central - Oxford B Research Ethics Committee

  • REC reference

    24/SC/0289

  • Date of REC Opinion

    9 Oct 2024

  • REC opinion

    Further Information Favourable Opinion