Risk factors for amendment in type, duration and setting of prescribed outpatient parenteral antimicrobial therapy (OPAT) for adult patients with cellulitis: a retrospective cohort study and CART analysis.

PURPOSE OF THE STUDY: To measure the percentage rate and risk factors for amendment in the type, duration and setting of outpatient parenteral antimicrobial therapy (OPAT) for the treatment of cellulitis. STUDY DESIGN: A retrospective cohort study of adult patients receiving OPAT for cellulitis was performed. Treatment amendment (TA) was defined as hospital admission or change in antibiotic therapy in order to achieve clinical response. Multivariable logistic regression (MVLR) and classification and regression tree (CART) analysis were performed. RESULTS: There were 307 patients enrolled. TA occurred in 36 patients (11.7%). Significant risk factors for TA on MVLR were increased age, increased Numerical Pain Scale Score (NPSS) and immunocompromise. The median OPAT duration was 7 days. Increased age, heart rate and C reactive protein were associated with treatment prolongation. CART analysis selected age <64.5 years, female gender and NPSS <2.5 in the final model, generating a low-sensitivity (27.8%), high-specificity (97.1%) decision tree. CONCLUSIONS: Increased age, NPSS and immunocompromise were associated with OPAT amendment. These identified risk factors can be used to support an evidence-based approach to patient selection for OPAT in cellulitis. The CART algorithm has good specificity but lacks sensitivity and is shown to be inferior in this study to logistic regression modelling.

Topical non-steroidal anti-inflammatory drugs for analgesia in traumatic corneal abrasions.

BACKGROUND: Traumatic corneal abrasions are relatively common and there is a lack of consensus about analgesia in their management. It is therefore important to document the clinical efficacy and safety profile of topical ophthalmic non-steroidal anti-inflammatory drugs (NSAIDs) in the management of traumatic corneal abrasions. OBJECTIVES: To identify and evaluate all randomised controlled trials (RCTs) comparing the use of topical NSAIDs with placebo or any alternative analgesic interventions in adults with traumatic corneal abrasions (including corneal abrasions arising from foreign body removal), to reduce pain, and its effects on healing time. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2017, Issue 2), MEDLINE Ovid (1946 to 30 March 2017), Embase Ovid (1947 to 30 March 2017), LILACS (Latin American and Caribbean Health Sciences Literature Database) (1982 to 30 March 2017), OpenGrey (System for Information on Grey Literature in Europe) (www.opengrey.eu/); searched 30 March 2017, ZETOC (1993 to 30 March 2017), the ISRCTN registry (www.isrctn.com/editAdvancedSearch); searched 30 March 2017, ClinicalTrials.gov (www.clinicaltrials.gov); searched 30 March 2017 and the WHO International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en); searched 30 March 2017. We did not use any date or language restrictions in the electronic searches for trials.We checked the reference lists of identified trials to search for further potentially relevant studies. SELECTION CRITERIA: RCTs comparing topical NSAIDs to placebo or any alternative analgesic interventions in adults with traumatic corneal abrasions. DATA COLLECTION AND ANALYSIS: Two review authors independently performed data extraction and assessed risks of bias in the included studies. We rated the certainty of the evidence using GRADE. MAIN RESULTS: We included nine studies that met the inclusion criteria, reporting data on 637 participants.The studies took place in the UK, USA, Israel, Italy, France and Portugal. These studies compared five types of topical NSAIDs (0.1% indomethacin, 0.03% flurbiprofen, 0.5% ketorolac, 1% indomethacin, 0.1% diclofenac) to control (consisting of standard care and in four studies used placebo eye drops). Overall, the studies were at an unclear or high risk of bias (particularly selection and reporting bias). None of the included studies reported the primary outcome measures of this review, namely participant-reported pain intensity reduction of 30% or more or 50% or more at 24 hours. Four trials, that included data on 481 participants receiving NSAIDs or control (placebo/standard care), reported on the use of 'rescue' analgesia at 24 hours as a proxy measure of pain control. Topical NSAIDs were associated with a reduction in the need for oral analgesia compared with control (risk ratio (RR) 0.46, 95% confidence interval (CI) 0.34 to 0.61; low-certainty evidence). Approximately 4 out of 10 people in the control group used rescue analgesia at 24 hours. No data were available on the use of analgesia at 48 or 72 hours.One trial (28 participants) reported on the proportion of abrasions healed after 24 and 48 hours. These outcomes were similar in both arms of the trial. (at 24 hours RR 1.00 (0.81 to 1.23); at 48 hours RR 1.00 (0.88 to 1.14); low-certainty evidence). In the control group nine out of 10 abrasions were healed within 24 hours and all were healed by 48 hours. Complications of corneal abrasions were reported in 6 studies (609 participants) and were infrequently reported (4 complications, 1 in NSAID groups (recurrent corneal erosion) and 3 in control groups (2 recurrent corneal erosions and 1 corneal abscess), very low-certainty evidence). Possible drug-related adverse events (AEs) were reported in two trials (163 participants), with the number of adverse events low (4 AEs, 3 in NSAID group, including discomfort/photophobia on instillation, conjunctival hyperaemia and urticaria, and 1 in the control group, corneal abscess) very low-certainty evidence. AUTHORS' CONCLUSIONS: The findings of the included studies do not provide strong evidence to support the use of topical NSAIDs in traumatic corneal abrasions. This is important, since NSAIDs are associated with a higher cost compared to oral analgesics. None of the trials addressed our primary outcome measure of participant-reported pain intensity reduction of 30% or more or 50% or more at 24 hours.

A prospective observational study of techniques to remove corneal foreign body in the emergency department.

INTRODUCTION: Patients  with corneal foreign bodies (CFBs) often present to the emergency department (ED). However, removal techniques vary among emergency physicians (EPs). A prospective, single-blinded, observational study was performed to compare slit-lamp-aided (SLA) versus non-slit-lamp-aided (NSLA) CFB removal by EPs. METHODS: Five EPs enrolled consecutive patients with a CFB over 3 months. One blinded EP reviewed patients after 3 days. The study end points were: change in visual acuity; visual analogue pain scale (VAS) score at 12 and 24 h; satisfaction rating; symptoms at follow-up; and rate of complications. RESULTS: 54 patients were enrolled: 28 had SLA removal and 26 NSLA removal; 52 were male; 22 had undergone previous CFB removal; six were wearing eye protection at the time of injury. Forty-three patients were reviewed: 26 by attendance and 18 by telephone. There was no difference in any end points at review. However, patients in the SLA group had median VAS scores that were 1.5 cm lower after 24 h than patients in the NSLA group (p=0.43, 95% CI -2.0 to 1.0). One patient in the SLA group developed keratitis. CONCLUSIONS: We show that patient satisfaction ratings, complications and visual acuity were similar for the two methods. There was a trend for increased pain in the NSLA group at 12 and 24 h. Slit-lamp biomicroscopy and the use of magnification to remove CFBs remains the gold standard of care, and more intensive training should be given to EPs at the departmental level, particularly in EDs that receive patients with eye injuries.

Prevalence and predictors of oral to intravenous antibiotic switch among adult emergency department patients with acute bacterial skin and skin structure infections: a pilot, prospective cohort study.

OBJECTIVE: To determine the prevalence and predictors of oral to intravenous antibiotic switch among adult emergency department (ED) patients with acute bacterial skin and skin structure infections (ABSSSIs). DESIGN: Multicentre, pilot cohort study. SETTING: Three urban EDs in Dublin, Ireland. PARTICIPANTS: Consecutive ED patients aged >16 years old with ABSSSIs between March 2015 and September 2016. INTERVENTION: Oral flucloxacillin 500 mg-1 g four times a day (alternative in penicillin allergy). PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was to determine the prevalence and predictors of oral to intravenous antibiotic switch. Secondary outcomes were to determine the prevalence and predictors of receiving an extended course of oral antibiotic treatment and measurement of interobserver reliability for clinical predictors at enrolment. RESULTS: Overall, 159 patients were enrolled of which eight were lost to follow-up and five were excluded. The majority of patients were male (65.1%) and <50 years of age (58.2%). Oral to intravenous antibiotic switch occurred in 13 patients (8.9%; 95% CI 4.8% to 14.7%). Increased lesion size (OR 1.74; 95% CI 1.09 to 2.79), white cell count (OR 1.32; 95% CI 1.05 to 1.67), athlete's foot (OR 8.00; 95% CI 2.31 to 27.71) and fungal nail infections (OR 7.25; 95% CI 1.99 to 26.35) were associated with oral to intravenous antibiotic switch. 24.8% (95% CI 18.1% to 33.0%) of patients received an extended course of oral antibiotic treatment. CONCLUSION: The prevalence of oral to intravenous antibiotic switch in this pilot study is 8.9% (95% CI 4.8% to 14.7%). We identify the predictors of oral to intravenous switch worthy of future investigation. TRIAL REGISTRATION NUMBER: NCT02230813.

Use of prophylactic antibiotic in preventing complications for blunt and penetrating chest trauma requiring chest drain insertion: a systematic review and meta-analysis.

BACKGROUND: Chest drain insertion after chest trauma is often associated with high rate of complications. The use of prophylactic antibiotics in patients with blunt and penetrating chest trauma to prevent empyema and pneumonia after chest drain insertion has been debated. OBJECTIVE: To analyze the effectiveness of prophylactic antibiotics versus placebo to prevent complications in patients with blunt and penetrating chest injuries who require the insertion of a chest drain. METHODS: Pubmed, Embase, and grey literature databases were searched during May 2017 for randomized clinical trails comparing prophylactic antibiotic versus placebo in patients with chest injuries requiring chest drain insertion. Good quality randomized studies which met the inclusion criteria were assessed using the Cochrane Collaboration tool for assessing risk of bias and then were included in the systematic review. A meta-analysis of the included studies was concluded using Stata to analyze the relative risk of empyema and pneumonia in these patients. RESULTS: The study identified 12 randomized studies that included 1263 patients with isolated blunt and penetrating chest trauma. The incidence of empyema after a chest drain insertion was 1% in the antibiotic group and 7.2% in the placebo group. The incidence of pneumonia after a chest drain insertion was 4.4% in the antibiotic group and 10.7% in the placebo group. The use prophylactic antibiotic in those patients was associated with a reduced risk of empyema (relative risk [RR] 0.25; 95% CI 0.13 to 0.49) and pneumonia (RR 0.41; 95% CI 0.24 to 0.71) after chest drain insertion when compared with placebo alone. CONCLUSION: Prophylactic antibiotic administration in patients with penetrating and blunt chest injuries requiring the insertion of a chest drain was associated with a reduced risk for post-traumatic empyema and pneumonia. Further studies should evaluate the optimal type, dose, and duration of antibiotic given to patients with chest trauma requiring chest drain insertion.

Evaluation of simulation methods for teaching peripheral arterial examination to medical students.

Physical examination is a critical component of medical practice yet the focus on efficient patient turnover has impacted the availability of patients with clinical findings willing to be examined by students and skills' teaching is not consistent across clinical rotations. This work evaluates simulation methodologies for teaching of the peripheral arterial examination and evaluates whether skills learnt are transferable to clinical practice. Second-year medical students were taught peripheral arterial examination on a SimMan 3G or with simulated patients (SPs). Both groups were assessed by Objective Structured Clinical Examination (OSCE) with outpatients who have been diagnosed with peripheral arterial disease. There was no difference in the pass rate at OSCE between the two groups. SimMan better facilitated repeated practice, group learning, peer teaching and discussion, which were highly valued by the students. Students felt that the SImMan tutorial did not facilitate development of spatial cognition or pattern recognition. They also felt less well prepared to deal with real patients in terms of having practised appropriate language, issuing instructions and attempting to reassure patients. Both methods of simulation teaching have distinct merits and the ideal approach maybe to use the SimMan in combination with SPs.

Recent trends in chlamydial and gonococcal conjunctivitis among neonates and adults in an Irish hospital.

BACKGROUND: Chlamydia trachomatis and Neisseria gonorrhoeae are two important and frequently overlooked causes of neonatal and adult conjunctivitis. OBJECTIVES AND METHODS: In order to improve primary treatment, prevention, and control of infection caused by these organisms, an analysis of all cases presenting from July 2002 to December 2006 at a major Irish regional teaching hospital was performed. RESULTS: There were 51 cases of conjunctivitis in total. Among neonates and adults, C. trachomatis was the most common cause of conjunctivitis. Of the adult patients, 75% were men. The annual incidence of adult chlamydial conjunctivitis increased yearly from 2002 and correlated with an overall increase in genital chlamydia infection in the region. Neonatal chlamydial conjunctivitis has an overall incidence of 0.65/1000 live births and is continuing to rise annually. In 2006, gonococcal conjunctivitis accounted for 20% of all cases of conjunctivitis caused by sexually transmitted bacteria presenting to our hospital. CONCLUSIONS: The recent increase in the incidence of gonococcal keratitis serves to remind us that this important infection should be borne in mind when treating cases of purulent conjunctivitis. The diagnosis of chlamydial and gonococcal conjunctivitis requires a high index of suspicion and prompt treatment with systemic antibiotics.

A comparison of on-line and off-line bioaerosol measurements at a biowaste site.

An air measurement campaign was carried out at a green-waste composting site in the South of Ireland during Spring 2016. The aim was to quantify and identify the levels of Primary Biological Aerosol Particles (PBAP) that were present using the traditional off-line, impaction/optical microscopy method alongside an on-line, spectroscopic approach termed WIBS (Wideband Integrated Bioaerosol Sensor), which can provide number concentrations, sizes and "shapes" of airborne PBAP in real-time by use of Light Induced Fluorescence (LIF). The results from the two techniques were compared in order to validate the use of the spectroscopic method for determining the releases of the wide-range of PBAP present there as a function of site activity and meteorological conditions. The seven-day monitoring period undertaken was much longer than any real-time studies that have been previously performed and allowed due comparison between weekday (working) activities at the site and weekend (closed) releases. The time-span also allowed relationships between site activities like turning, agitation or waste delivery and the WIBS data to be determined in a quantitative manner. This information cannot be obtained with the Andersen Sampling methods generally employed at green-waste management sites. Furthermore, few specific bioaerosol types other than Aspergillus fumigatus, are identified using the traditional protocols employed for site licensing purposes. Here though the co-location of WIBS with the impaction instrument made it possible to identify the real-time release behaviour of a specific plant pathogenic spore, Ustilago maydis, present after green-waste deliveries were made by a local distillery.

The Penicillin for the Emergency Department Outpatient treatment of CELLulitis (PEDOCELL) trial: update to the study protocol and detailed statistical analysis plan (SAP).

BACKGROUND: Cellulitis is a painful, potentially serious, infectious process of the dermal and subdermal tissues and represents a significant disease burden. The statistical analysis plan (SAP) for the Penicillin for the Emergency Department Outpatient treatment of CELLulitis (PEDOCELL) trial is described here. The PEDOCELL trial is a multicentre, randomised, parallel-arm, double-blinded, non-inferiority clinical trial comparing the efficacy of flucloxacillin (monotherapy) with combination flucloxacillin/phenoxymethylpenicillin (dual therapy) for the outpatient treatment of cellulitis in the emergency department (ED) setting. To prevent outcome reporting bias, selective reporting and data-driven results, the a priori-defined, detailed SAP is presented here. METHODS/DESIGN: Patients will be randomised to either orally administered flucloxacillin 500 mg four times daily and placebo or orally administered 500 mg of flucloxacillin four times daily and phenoxymethylpenicillin 500 mg four times daily. The trial consists of a 7-day intervention period and a 2-week follow-up period. Study measurements will be taken at four specific time points: at patient enrolment, day 2-3 after enrolment and commencing treatment (early clinical response (ECR) visit), day 8-10 after enrolment (end-of-treatment (EOT) visit) and day 14-21 after enrolment (test-of-cure (TOC) visit). The primary outcome measure is investigator-determined clinical response measured at the TOC visit. The secondary outcomes are as follows: lesion size at ECR, clinical treatment failure at each follow-up visit, adherence and persistence of trial patients with orally administered antibiotic therapy at EOT, health-related quality of life (HRQoL) and pharmacoeconomic assessments. The plan for the presentation and comparison of baseline characteristics and outcomes is described in this paper. DISCUSSION: This trial aims to establish the non-inferiority of orally administered flucloxacillin monotherapy with orally administered flucloxacillin/phenoxymethylpenicillin dual therapy for the ED-directed outpatient treatment of cellulitis. In doing so, this trial will bridge a knowledge gap in this understudied and common condition and will be relevant to clinicians across several different disciplines. The SAP for the PEDOCELL trial was developed a priori in order to minimise analysis bias. TRIAL REGISTRATION: EU Clinical Trials Register (EudraCT number: 2016-001528-69). Registered on 5 April 2016. ClinicalTrials.gov, ID: NCT02922686 . Registered on 9 August 2016.

The management of cellulitis in emergency departments: antibiotic-prescribing practices and adherence to practice guidelines in Ireland.

OBJECTIVES: There is a lack of evidence to guide the management of cellulitis in the emergency department (ED). The primary aim of this study was to characterize antibiotic-prescribing practices for the treatment of cellulitis in Irish EDs. Secondary aims were to identify patient variables associated with the prescription of intravenous (i.v.) antibiotics and to describe the utility of three published guidelines for the management of cellulitis in the ED. METHODS: This was a multicentre, prospective, observational cross-sectional study of consecutive patients presenting to six EDs in Ireland over a 1-month period (June 2012). RESULTS: In total, 117 patients were enrolled. Fifty-five percent of all patients (n=65) were referred from primary care, and emergency physicians prescribed i.v. therapy in 50% of patients (n=59) overall. Nonpurulent cellulitis accounted for 96.5% of cases (n=113). Flucloxacillin, either alone or with penicillin V, is the most commonly prescribed oral antibiotic in patients both referred from primary care and discharged from the ED. Flucloxacillin with benzylpenicillin is the most commonly prescribed i.v. TREATMENT: Fever, increasing diameter of infection, and tinea pedis were associated with prescription of i.v. antibiotics by emergency physicians. The three guidelines examined in this study recommended oral antibiotic treatment for between 33-44% of patients who were treated with i.v. antibiotics by emergency physicians. CONCLUSION: In Ireland, current prescribing practices for CREST 1 and modified CREST 1 and 2 patients are poorly adherent to guideline recommendations.

Treatment outcome measures for randomized controlled trials of antibiotic treatment for acute bacterial skin and skin structure infections in the emergency department setting.

Acute bacterial skin and skin structure infections (ABSSSIs), which include cellulitis, abscesses, and wound infections, are among the most commonly encountered conditions in emergency departments (EDs) internationally. Primarily, as a result of the recent epidemic of community-associated methicillin resistant Staphylococcus aureus (CA-MRSA) in North America, ED attendances and hospital admissions secondary to ABSSSIs have increased significantly. First-line antibiotic drug therapies for ABSSSIs have therefore changed to take account of CA-MRSA and the threat of evolving antibiotic resistance. Prior to 2010, randomized controlled trials (RCTs) of antibiotic therapy for ABSSSI used broad trial inclusion criteria and utilized investigator-determined clinical resolution, 7 to 14 days after the end of therapy, as the primary outcome measure. In order to produce more objective, reproducible, and quantifiable primary outcome measures, the US Food and Drug Administration (FDA) Center for Drug Evaluation and Research and a multidisciplinary consortium convened by the Foundation for the National Institutes of Health (FNIH) issued significantly changed trial guidance criteria. The currently recommended primary outcome measure is an assessment of greater than 20% reduction in the area of erythema, edema, or induration from baseline, measured at 48 to 72 h after randomization and initiation of drug treatment. In contrast, the European Medicines Agency (EMA) still recommends measurement of clinical resolution at a later time period. We discuss the evolution of changes to trial guidance criteria issued by the FDA since 1998 and the potential difficulties of implementing the recommended primary outcome measured at an earlier time point in RCTs of outpatient antibiotic treatment performed in the ED setting.

Prevalence and predictors of initial oral antibiotic treatment failure in adult emergency department patients with cellulitis: a pilot study.

INTRODUCTION: Assessment of cellulitis severity in the emergency department (ED) setting is problematic. Given the lack of research performed to describe the epidemiology and management of cellulitis, it is unsurprising that heterogeneous antibiotic prescribing and poor adherence to guidelines is common. It has been shown that up to 20.5% of ED patients with cellulitis require either a change in route or dose of the initially prescribed antibiotic regimen. The current treatment failure rate for empirically prescribed oral antibiotic therapy in Irish EDs is unknown. The association of patient risk factors with treatment failure has not been described in our setting. Lower prevalence of community-acquired methicillin-resistant Staphylococcus aureus-associated infection, differing antibiotic prescribing preferences and varying availability of outpatient intravenous therapy programmes may result in different rates of empiric antibiotic treatment failure from those previously described. METHODS AND ANALYSIS: Consecutive ED patients with cellulitis will be enrolled on a 24/7 basis from 3 Irish EDs. A prespecified set of clinical variables will be measured on each patient discharged on empiric oral antibiotic therapy. A second independent study recruiter will assess at least 10% of cases for each of the predictor variables. Follow-up by telephone call will occur at 14 days for all discharged patients where measurement of the primary outcome will occur. Our primary outcome is treatment failure, defined as a change in route of antibiotic administration from oral to intravenous antibiotic. Our secondary outcome is change in dose or type of prescribed antibiotic. A cohort of approximately 152 patients is required to estimate the proportion of patients failing oral antibiotic treatment with a margin of error of 0.05 around the estimate. ETHICS AND DISSEMINATION: Full ethics approval has been granted. An integrated dissemination plan, involving diverse clinical specialties and enrolled patients, is described. TRIAL REGISTRATION NUMBER: NCT 02230813.

Are two penicillins better than one? A systematic review of oral flucloxacillin and penicillin V versus oral flucloxacillin alone for the emergency department treatment of cellulitis.

BACKGROUND: Flucloxacillin either alone or combined with penicillin V is still the first-line antibiotic drug of choice for the treatment of cellulitis in emergency departments (EDs) in Ireland. The rationale for this antibiotic regimen is their anti-staphylococcal and anti-streptococcal activity. OBJECTIVE: To determine the clinical efficacy, tolerability and safety of oral flucloxacillin alone (monotherapy) compared with a combination of flucloxacillin with penicillin V (dual therapy) in the ED-directed outpatient treatment of cellulitis. METHODS: We searched the following electronic databases: MEDLINE (1950 to August 2011), EMBASE (1980 to August 2011), Cochrane Central Register of Controlled Clinical Trials (CENTRAL) (The Cochrane Library 2011, Issue), OpenGrey, Current Controlled Trials metaRegister of Clinical Trials (August 2011) and reference lists and websites of potential trials. We performed cross-referencing from the reference lists of major articles on the subject. We imposed no language restriction. RESULTS: Despite a comprehensive literature search to identify relevant studies, no randomized-controlled trials that fulfilled the inclusion criteria were found. CONCLUSIONS: Despite its common use, there are no published randomized-controlled trials comparing flucloxacillin monotherapy with a combination of flucloxacillin and penicillin V in the ED management of cellulitis. We discuss existing European and North American prescribing rationale and current guidelines.

Oral flucloxacillin and phenoxymethylpenicillin versus flucloxacillin alone for the emergency department outpatient treatment of cellulitis: study protocol for a randomised controlled trial.

BACKGROUND: Oral flucloxacillin, either alone or in combination with phenoxymethylpenicillin, is a commonly prescribed antibiotic for the treatment of cellulitis, particularly in Ireland and the United Kingdom. This study aims to establish the non-inferiority of oral monotherapy (flucloxacillin alone) to dual therapy (flucloxacillin and phenoxymethylpenicillin) for the outpatient treatment of cellulitis in adults. METHODS/DESIGN: This study is a multicentre, randomised, double-blind, placebo-controlled trial of adults who present to the emergency department (ED) with cellulitis that is deemed treatable on an outpatient basis with oral antibiotics. After fulfilling specified inclusion and exclusion criteria, informed consent will be taken. Patients will be given a treatment pack containing 7 days of treatment with flucloxacillin 500 mg four times daily and placebo or flucloxacillin 500 mg four times daily and phenoxymethylpenicillin 500 mg four times daily. The primary outcome measure under study is the proportion of patients in each group in which there is greater than or equal to a 50% reduction in the area of diameter of infection from the area measured at enrolment at the end-of-treatment visit (7 to 10 days). Secondary endpoints include a health-related quality of life measurement as rated by the SF-36 score and the Extremity Soft Tissue Infection Score (not validated), compliance and adverse events. Patients will be followed up by telephone call at 3 days, end-of-treatment visit (EOT) at 7 to 10 days and test-of-cure (TOC) visit at 30 days. To achieve 90% power, a sample size of 172 patients per treatment arm is needed. This assumes a treatment success rate of 85% with oral flucloxacillin and phenoxymethylpenicillin, an equivalence threshold Δ = 12.5% and an α = 0.025. Non-inferiority will be assessed using a one-sided confidence interval on the difference of proportions between the two groups. Standard analysis including per-protocol and intention-to-treat will be performed. DISCUSSION: This trial aims to establish the non-inferiority of flucloxacillin monotherapy to dual therapy in the treatment of uncomplicated cellulitis among ED patients. In doing so, this trial will bridge a knowledge gap in this understudied and common condition and will be relevant to clinicians across several different disciplines.