Background: Few studies have addressed the appropriate duration of antibiotic therapy for diabetic foot infections (DFI) with or without amputation. We will perform two randomized clinical trials (RCTs) to reduce the antibiotic use and associated adverse events in DFI. Methods: We hypothesize that shorter durations of postdebridement systemic antibiotic therapy are noninferior (10% margin, 80% power, alpha 5%) to existing (long) durations and we will perform two unblinded RCTs with a total of 400 DFI episodes (randomization 1:1) from 2019 to 2022. The primary outcome for both RCTs is remission of infection after a minimal follow-up of 2 months. The secondary outcomes for both RCTs are the incidence of adverse events and the overall treatment costs. The first RCT will allocate the total therapeutic amputations in two arms of 50 patients each: 1 versus 3 weeks of antibiotic therapy for residual osteomyelitis (positive microbiological samples of the residual bone stump); or 1 versus 4 days for remaining soft tissue infection. The second RCT will randomize the conservative approach (only surgical debridement without in toto amputation) in two arms with 50 patients each: 10 versus 20 days of antibiotic therapy for soft tissue infections; and 3 versus 6 weeks for osteomyelitis. All participants will have professional wound debridement, adequate off-loading, angiology evaluation, and a concomitant surgical, re-educational, podiatric, internist and infectiology care. During the surgeries, we will collect tissues for BioBanking and future laboratory studies. Discussion: Both parallel RCTs will respond to frequent questions regarding the duration of antibiotic use in the both major subsets of DFIs, to ensure the quality of care, and to avoid unnecessary excesses in terms of surgery and antibiotic use. Trial registration: ClinicalTrials.gov, NCT04081792. Registered on 4 September 2019.

Background: Few studies address the appropriate duration of antibiotic therapy for diabetic foot infections (DFI); with or without amputation. We will perform two randomized clinical trials (RCT) to reduce the antibiotic use and associated adverse events in DFI. Methods: We hypothesize that shorter durations of post-debridement systemic antibiotic therapy are non-inferior (10% margin, 80% power, ɑ 5%) to existing (long) durations and we will perform two unblinded RCTs with a total of 400 DFI episodes (randomization 1:1) from 2019 to 2022. The primary outcome for both RCT is “remission of infection” after a minimal follow-up of two months. The secondary outcomes for both RCT are the incidence of adverse events and the overall treatment costs. The First RCT will allocate the total therapeutic amputations in two arms of 50 patients each: 1 vs. 3 weeks of antibiotic therapy for residual osteomyelitis (positive microbiological samples of the residual bone stump); or 1 vs. 4 days for remaining soft tissue infection. The Second RCT will randomize the conservative approach (only surgical debridement without in toto amputation) in two arms with 50 patients each: 10 vs. 20 days of antibiotic therapy for soft tissue infections; and 3 vs. 6 weeks for osteomyelitis. All participants will have professional wound debridement, adequate off-loading, angiology evaluation, and a concomitant surgical, re-educational, podiatric, internist and infectiology care. During the surgeries, we will collect tissues for BioBanking and future laboratory studies. Discussion: Both parellel RCTs will repond to frequent questions regarding the duration of antibiotic use in the both major subsets of DFIs, to assure the quality of care, and to avoid unnecessary excesses in terms of surgery and antibiotic use. Trial registration: ClinicalTrial.gov NCT04081792. Registered on 4th September 2019. Protocol version: 2 (15th July 2019)

Abstract. The incidence of surgical site infections (SSIs) after elective tumour orthopaedic surgery in adults is higher than non-oncologic orthopaedic surgery. Their causative microorganisms and antibiotic susceptibilities are also different from the non-oncologic cases; with no apparent predictable microbiological patterns. Clinicians continue to struggle to tailor the optimal prophylactic regimen for the very heterogeneous group of tumour patients. Many clinicians thus prolong the first-and second-generation cephalosporin agents, while a minority chooses to broaden the antimicrobial spectrum by combination prophylaxis. The variability in current practices and surgical techniques is enormous, even within the same setting. The scientific literature lacks adequate retrospective case-studies and there is currently only one prospective randomized trial. In this narrative review, we discuss various perioperative antibiotic concepts in oncologic orthopaedic surgery, including a summary of the state-to-the-art, opinions and difficulties related to the different prophylactic strategies.

Background: The contralateral foot in Charcot arthropathy or neuroarthropathy (CN) is subject to increased plantar pressure. To date, the clinical consequences of this pressure elevation are yet to be determined. The aim of this study was to evaluate ulcer and amputation rates of the contralateral foot in CN. Methods: We abstracted the medical records of 130 consecutive subjects with unilateral CN. Rates of contralateral CN development and recurrence, contralateral ulcer development, and contralateral amputations were recorded. Statistical analysis was performed to identify possible risk factors for contralateral CN and ulcer development, and contralateral amputation. Mean follow-up was 6.2 (SD 4) years. Results: After a mean of 2.5 years, 19.2% patients developed contralateral CN. Female gender was associated with contralateral CN development (odds ratio 3.13, 95% confidence interval 1.27, 7.7). Overall, 46.2% patients developed a contralateral ulcer. Among the patients who developed contralateral CN, 60% developed an ulcer. Sanders type 2 at the index foot (midfoot CN) was significantly associated with contralateral ulcer development. Ulcer-free survival (UFS) differed significantly between patients with diabetes type 1 (median UFS 5131 days) and patients with diabetes type 2 (median UFS 2158 days). A total of 25 amputations had to be performed in 22 (16.9%) patients. Three of those 22 patients (2.3%) needed major amputation. Conclusion: Almost 20% of patients developed contralateral CN. Nearly half of people with CN developed a contralateral foot ulceration. Patients with type 2 diabetes had significantly shorter UFS than patients with diabetes type 1. Every sixth patient needed an amputation, with the majority being minor amputations. The contralateral foot should be monitored closely and included in the treatment in patients with CN. Level of Evidence: Level IV, retrospective study.

No abstract