None listed
Conditions
Brief summary
Cellulitis is a common, painful and disabling condition where bacterial infection spreads under the skin to cause a red, hot swollen leg. The current standard treatment of cellulitis is antibiotics to kill the responsible bacteria. This treatment is usually successful, however, most people require antibtiotic treatment, rest and time off work for 10-14 days. A single unblinded small RCT of ibuprofen as adjunctive therapy has previously shown that patients receiving ibuprofen had substantially more rapid regression of cellulitis than those receiving antibiotics alone, with no increase in adverse effects. We plan to conduct a pilot double-blinded randomised controlled trial of adjunctive ibuprofen versus placebo in patients with uncomplicated lower limb cellulitis to determine if this strategy leads to more rapid resolution of inflammation than standard therapy alone.
Interventions
Ibuprofen tablets (Herron blue brand 200mg tablets) 400mg three times per day orally for five days, in addition to usual antibiotic therapy (Cephazolin 2 grams twice per day intravenously until clinically improved, then oral antibitoics as prescribed by the treating clinicians)
Sponsors
Dr Josh Davis
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1) Age >=18 years. 2) Uncomplicated lower limb cellulitis or erysipelas. Cellulitis/erysipelas are defined as being present if the diagnosis has been made by an Infectious Diseases registrar or consultant. The following will be considered “complicated” and will thus not be eligible: Abscess requiring surgical intervention. Post-operative wound infection. Coexisting deep venous thrombosis. Suspected or proven necrotising fasciitis or gas gangrene. Cellulitis extending superior to the inguinal ligament. 3) Admitted directly to the Hospital in the Home unit from the emergency department or a referring GP. 4) Receiving intravaneous Cefazolin 2grams every 12 hours 5) Able to be randomised within 24 hours of the first dose of effective IV antibiotics.
Exclusion criteria
1) Allergy to non-steroidal anti-inflammatory drugs including aspirin. 2) Definite history of current peptic ulcer or past complicated peptic ulcer. 3) Acute renal impairment (Serum Creatinine>120). 4) Chronic renal impairment with eGFR<50. 5) Current Varicella or zoster infection (chicken pox or shingles). 6) Iatrogenic immunosuppression. 7) Known pregnancy. 8) Currently taking regular anti-inflammatory drugs that cannot be ceased 9) Currently taking therapeutic anticoagulation or potent antiplatelet agents
Outcome results
None listed