Importance Previous research has suggested that intrawound vancomycin powder reduces deep surgical site infections among patients with periarticular tibial fractures at high risk of infection. It is unknown whether the addition of tobramycin powder further decreases infection rates. Objective To compare whether the combination of tobramycin plus vancomycin vs vancomycin alone delivered as intrawound powder at the time of definitive fixation reduces deep surgical site infections. Design, Setting, and Participants Open-label, assessor-masked, randomized clinical trial conducted at 39 US trauma centers. Eligible patients were adults with an operatively treated periarticular tibial fracture (either tibial plateau or pilon) who met 1 of 3 criteria for elevated infection risk. Enrollment occurred between June 18, 2021, and December 12, 2024 (final follow-up, July 15, 2025). Interventions Intrawound tobramycin (1.2 g) plus vancomycin (1.0 g) powder vs intrawound vancomycin (1.0 g) powder delivered at the time of definitive fixation. Main Outcomes and Measures The primary outcome was a deep surgical site infection requiring surgical management within 182 days of definitive fracture fixation. Secondary outcomes included deep surgical site infections with pathogens that were gram-negative only, deep surgical site infections with at least 1 pathogen that was gram-positive, deep surgical site infections with polymicrobial cultures, deep surgical site infections with negative culture results, and cellulitis or skin infections treated only with antibiotics. Results Among the 1660 participants randomized, 1528 (mean age, 47.0 [SD, 14.3] years; 603 female [39.5%]; 925 male [60.5%]) were included in the primary analysis. Deep surgical site infections occurred in 51 of 753 participants (182-day probability, 7.4%) in the tobramycin plus vancomycin group and 47 of 775 participants (182-day probability, 6.6%) in the vancomycin alone group (hazard ratio, 1.11; 95% bayesian credible interval, 0.75-1.66; posterior probability of superiority, 29.7%). The threshold required for superiority was not reached for any secondary outcome. Conclusions and Relevance Among patients with operatively treated periarticular tibial fractures at high risk of infection, adding intrawound tobramycin powder to vancomycin powder at the time of definitive fixation did not reduce deep surgical site infections compared with vancomycin powder alone. Trial Registration ClinicalTrials.gov Identifier: NCT02227446
Abstract Introduction Infliximab is a commonly used tumor necrosis factor (TNF) alpha inhibitor. Adverse reactions include reactivation of tuberculosis, serum sickness. A rare, reported complication includes pericarditis. Case Presentation A 59-year-old female with chronic respiratory failure, sarcoidosis, pulmonary hypertension presented with acute chest pain that improved when leaning forward. Laboratory results revealed elevated troponin, C-reactive protein, and brain natriuretic peptide. A chest X-ray raised concern for an enlarged cardiac contour, while an electrocardiogram showed normal sinus rhythm with low voltage. Transthoracic echocardiography demonstrated a moderate-to-large pericardial effusion with diastolic collapse of the right ventricle, and a fibrinous/inflammatory mass along the free wall. A heart catheterization did not show equalization of diastolic pressures. A pericardial window was performed to drain the fibrinous fluid and evaluate the underlying etiology. The patient was treated with nonsteroidal anti-inflammatory drugs, colchicine, and prednisone. The infectious workup, including bacterial, viral, fungal, and acid-fast bacilli (AFB) pericardial fluid cultures, was negative. Fluid cytology and a recent PET scan did not raise concerns for malignancy. Autoimmune testing revealed elevated nuclear homogenous anti-neutrophilic antibodies (ANA) with negative immunofluorescence assay, anti-histone antibodies, and myositis panel. The patient had no history of recent trauma or radiation exposure. She was discharged but readmitted due to concerns for recurrent pericarditis. Infliximab was subsequently discontinued with resultant symptomatic resolution. Discussion Infliximab is increasingly used to treat various conditions, including inflammatory bowel disease, rheumatoid arthritis, plaque psoriasis. While generally well tolerated, infliximab-induced pericarditis is a rare but recognized adverse reaction, with a reported prevalence of 0.19-0.22% in post-marketing studies. The exact incidence is unknown. The proposed mechanisms include direct cardiac toxicity, an IgE-mediated allergic response, humoral antibody activation, and a delayed cell-mediated hypersensitivity reaction, resembling serum sickness. It may be associated with the production of antinuclear antibodies (79%), double-stranded (ds) DNA antibodies (725), antihistone antibodies (17-57%), and others, developing drug-induced lupus. Onset can range from less than a month to over four years after initiation of therapy. The primary treatment is discontinuation of the drug. Clinicians should maintain a high index of suspicion for pericarditis in patients receiving infliximab and consider drug withdrawal if symptoms arise. Close monitoring for severe complications, such as pericardial effusion and systemic vasculitis, is also advised. References: Thiriveedi M, et al. J Gen Intern Med. 2021;36(7):2134-8. • Fonseca A, et al. Case Rep Pediatr. 2021;9989729. • Dipasquale V, et al. J Clin Pharm Ther. 2018;43(1):107-9. • Devasahayam J, et al. J Crohns Colitis. 2012;6(6):730-1. This abstract is funded by: none
Background Intraoperative radiation therapy has shown potential in early-stage breast cancer treatment. The single-arm, prospective, multi-institution ExBRT trial was designed to improve the quality of evidence in patients treated with lumpectomy and intraoperative electronic brachytherapy (IORT). Methods Women at least 40 years with single lesion invasive ductal carcinoma (IDC) or ductal carcinoma in situ (DCIS) no larger than 3 cm, cN0, treated with lumpectomy and IORT per protocol, were followed for ipsilateral breast tumor recurrence (IBTR), serious adverse events (SAEs), breast cancer-related and overall survival. Results At median 5-year follow-up, IBTR was diagnosed in 42(3.50%) of 1199 subjects, with a Kaplan-Meier probability of 4.21% (95%CI 2.86, 5.55). IBTR-related risk analyses identified age younger than 50 years, high-grade DCIS, Grade 3 IDC and endocrine therapy (ET) non-compliance to increase IBTR risk. SAEs were low at 1.4%. Breast cancer-related survival had a median 5-year Kaplan-Meier probability of 99.90% (95%CI 99.70, 100), with 1 breast cancer-related death. There were 46 unrelated deaths for an overall survival probability of 94.30% (95%CI 92.67, 95.95). Conclusions Patients treated with lumpectomy and IORT, delivered conveniently in a single setting, demonstrated low IBTR with minimal toxicity and excellent breast cancer-related and overall survival. This compared favorably to published early-stage breast cancer radiation omission and de-escalation radiotherapy results. Synopsis A single-arm, prospective, multi-institution research study (ExBRT trial) assessing IORT safety and efficacy immediately following lumpectomy using disposable balloon electronic brachytherapy. IORT, with a 4.21% Kaplan-Meier IBTR probability at median 5-year follow-up, is a convenient, less toxic treatment with results similar to early-stage breast cancer radiation omission and de-escalation radiotherapy results.
