Investigating the effect of dexamethasone in cellulitis
Eligibility
Local study conflicts
- None
Inclusion Criteria:
- Aged 16 years old or over
- A current clinical diagnosis of cellulitis at any body site except the orbit (periorbital/orbital cellulitis)
- Able to provide informed consent
- People of child-bearing* potential must be willing to:
- Use an effective method of contraception** (and must agree to continue 3 months after the last dose of the IMP)
- Inform the trial team if pregnancy occurs during trial participation
Exclusion Criteria:
- Orbital or periorbital cellulitis, surgical site infection, or planned surgical management (e.g abscess) as managed under a different clinical pathway
- Allergy to dexamethasone
- Contraindication to dexamethasone due to concurrent medication (e.g. cobicistat)
- Has known current invasive fungal infection**
- Has known current gastric or duodenal ulceration
- Already on corticosteroids
- Unable to take oral medication
- Lack of capacity
- Inability to complete follow-up procedures
- Prisoner*
- Pregnant***, breastfeeding, or planning to conceive in next 3 months
If the patient is eligible:
- Taking part in research is likely to improve the quality of their care
- Risks are carefully controlled - research is safe
- Explain the uncertainty that exists with respect to treatment of their condition;
- If they change their mind they can withdraw their participation at any point
Step by Step Guide to Recruitment:
In standard working hours; 9-5
- Please contact the ED Research Team when eligible patients arrive in ED:
Send the ED Research Team a message via Epic chat "ED research Team" or phone 217907
Out of hours and weekends:
- Complete screening log on REDCap. Check diabetes status of pt.
- Complete pregnancy test if female in appropriate age group (gain consent from the patient first).
- Collect paperwork from the rack in the ambulance bay with or without the tablet.
- The doctor on the delegation log needs to confirm eligibility and sign “Eligibility Check” form – this will also need to be documented in the Smartphrase.
- Approach patient and provide them with the Patient Information Sheet to read.
(QR code links to both patient information sheet and video are at the foot of the page) - Inform patients about follow-up text messages (texts will be sent at 8am and 8pm.)
- Consent on REDCap or paper consent form.
- Randomise using REDCap.
- Ask Dr to prescribe the trial drug (Investigation Medicinal Product, IMP) as per EPIC build.
- Collect the IMP from the drug cupboard.
- Administer the 1st dose.
- Complete the paperwork (handover sheet; questionnaire; Patient trial card)
- Place ALL the documentation in the research post box – in reception, behind where our receptionists sit
- Enter Smartphrase into EPIC to document, upload handover sheet to EPIC (via Haiku)
- 2nd dose to be administered 24hrs later.
Links for further information:
Tap these buttons for QR code links to the patient information video and text sheets, The link for the study homepage is at the foot.
