Background: Elective implant removal (IR) after fracture fixation is one of the most common procedures within (orthopedic) trauma surgery. The rate of surgical site infections (SSIs) in this procedure is quite high, especially below the level of the knee. Antibiotic prophylaxis is not routinely prescribed, even though it has proved to lower SSI rates in other (orthopedic) trauma surgical procedures. The primary objective is to study the effectiveness of a single intravenous dose of 2 g of cefazolin on SSIs after IR following fixation of foot, ankle and/or lower leg fractures. Methods: This is a multicenter, double-blind placebo controlled trial with a superiority design, including adult patients undergoing elective implant removal after fixation of a fracture of foot, ankle, lower leg or patella. Exclusion criteria are: an active infection, current antibiotic treatment, or a medical condition contraindicating prophylaxis with cefazolin including allergy. Patients are randomized to receive a single preoperative intravenous dose of either 2 g of cefazolin or a placebo (NaCl). The primary analysis will be an intention-to-treat comparison of the proportion of patients with a SSI at 90 days after IR in both groups. Discussion: If 2 g of prophylactic cefazolin proves to be both effective and cost-effective in preventing SSI, this would have implications for current guidelines. Combined with the high infection rate of IR which previous studies have shown, it would be sufficiently substantiated for guidelines to suggest protocolled use of prophylactic antibiotics in IR of foot, ankle, lower leg or patella. Trial registration Nederlands Trial Register (NTR): NL8284, registered on 9th of January 2020, https://www.trialregister.nl/trial/8284
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Background: The increasing numbers of surgeries involving high risk, multi-morbid patients, coupled with inconsistencies in the practice of perioperative surgical wound care, increases patients’ risk of surgical site infection and other wound complications. Objectives: To synthesise and evaluate the recommendations for nursing practice and research from published systematic reviews in the Cochrane Library on nurse-led pre-operative prophylaxis and post-operative surgical wound care interventions used or initiated by nurses. Design: Meta-review, guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Data sources: The Cochrane Library database. Review methods: All Cochrane Systematic Reviews were eligible. Two reviewers independently selected the reviews and extracted data. One reviewer appraised the methodological quality of the included reviews using A MeaSurement Tool to Assess Systematic Reviews 2 (AMSTAR 2) checklist. A second reviewer independently verified these appraisals. The review protocol was registered with the Prospective Register of Systematic Reviews. Results: Twenty-two Cochrane reviews met the inclusion criteria. Of these, 11 reviews focused on pre-operative interventions to prevent infection, while 12 focused on post-operative interventions (one review assessed both pre-and post-operative interventions). Across all reviews, 14 (63.6%) made at least one recommendation to undertake a specific practice, while two reviews (9.1%) made at least one specific recommendation not to undertake a practice. In relation to recommendations for further research, insufficient sample size was the most predominant methodological issue (12/22) identified across reviews. Conclusions: The limited number of recommendations for pre- and post-operative interventions reflects the paucity of high-quality evidence, suggesting a need for rigorous trials to address these evidence gaps in fundamentals of nursing care.
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