Eligibility

Local study conflicts

• None

Inclusion Criteria:

• Age ≥18 years
• Symptoms suggestive of cellulitis (pain, tenderness, redness or other change in skin colour, and warmth to touch) in one leg for 10 days or less, and where the clinical impression is of cellulitis as the most likely diagnosis.
• Pain rated ≥ 3/10 on a numeric rating scale (0-10) at baseline
• Able to complete trial procedures in English language (could be through the assistance of an interpreter).

Exclusion Criteria:

• Has had antibiotics for cellulitis within the past month
• Bilateral cellulitis
• Post-operative cellulitis (within 30 days of operative procedure on same leg
• Cellulitis resulting from a human/animal bite injury (cellulitis following an insect bite is eligible for inclusion)
• Cellulitis associated with chronic (>6 weeks) leg ulceration
• Patient requires immediate hospital admission or out-patient intravenous antibiotic therapy
• Known true allergy to penicillin or cephalosporins

If the patient is eligible:

• Gain verbal agreement in principle before proceeding. Inform the patient:
• That they may be eligible for a research study
• 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

• The team aims to be available 8am-4pm Monday to Friday;
• In research team working hours (If research team member is available, they will be signed in on alertive).
• Contact them via Ed research on alertive or extension 1041.

When the ED Research team is not available:

Estimated time to complete recruitment

• 30 minutes

Gather documentation

• Collect a patient pack from the shelves in the trolley bay

Gaining formal consent

• Complete contact details, eligibility confirmation form, consent form, and clinical baseline paper form in the pack (you may wish to allow the patient to complete their paperwork by themselves or support them with this).
• Give the patient the copy of the consent form and patient information leaflet

Tap the button below to display a QR code link to the patient information leaflet, for the patient to scan:

QR code link

Carrying out the intervention:

• Prescribe 5 days course of Flucloxacillin and ensure precisely only 5 day supply is dispensed
• Document on Trust paperwork (2 continuation sheets)
• Paperwork to be placed in Ched’s office on Laura’s desk (the research team will do all the data entry)
• Ensure that research team are informed immediately by email/alertive (as data entry needs to be done promptly and medication to be sent out).

Randomisation procedure

• The patient will be randomised after discharge, and the final 2 days of treatment (whether placebo or antibiotic) will be posted to them

Disposition and follow-up:

If admitted:

• Only patients medically fit for discharge are eligible for the study

If discharged:

• Daily questionnaires will be sent to the patient
• They will receive the final 2 days of treatment in the post
• There is no follow-up by the research team other than teh questionnaires
• Provide safety net advice:
  
  • If the patient becomes unwell, it will not help to try to contact the research team
  • If the patient deteriorates, their symptoms change or have any other concerns, contact 111, their GP or return to the ED

Links for further information:

Link to trial site

Link to online patient information sheet