Naproxen Versus Placebo as Adjunct Treatment of Cellulitis: A Randomized Controlled Trial

These are appropriate exclusions according to eligibility for treatment with naproxen in clinical practice, and we believe that relatively few patients will be excluded. We will exclude participants for any of the following reasons: (a) Age <18 years; (b) Patient already taking oral antibiotics or NSAIDs; (c) Treating physician decides IV antibiotics are required; (d) Skin abscess requiring incision and drainage; (e) Known prior skin or soft tissue infection secondary to methicillin-resistant Staphylococcus aureus (MRSA); (f) Cellulitis secondary to a human or animal bite; (g) Penetrating wound or water exposure resulting in cellulitis; (h) Surgical site infection; (i) Pregnancy or breastfeeding; (j) Prior gastric bypass surgery; (k) Patients on dual antiplatelet therapy; (l) Patients on warfarin, low molecular weight heparin, or direct oral anticoagulant therapy; (m) Severe uncontrolled heart failure, or coronary artery bypass grafting (CABG) surgery within 14 days prior to the index visit, or planned CABG surgery within 21 days following the index visit.; (n) History of gastric/duodenal ulcer or gastrointestinal bleeding in the past 12 months; (o) Known kidney impairment with an estimated glomerular filtration rate <30 mL/min documented on the electronic health record at any time within the past three months; (p) Known hyperkalemia documented on the electronic health record at any time within the past three months; (q) Liver cirrhosis; (r) Inflammatory bowel disease; (s) History of asthma, urticaria or allergic reactions after taking NSAIDs or aspirin; (t) Allergy to cephalosporins or history of anaphylaxis to penicillin; (u) Inability to provide informed consent.