Surgeons are injecting antibiotic beads or coating metal implants with drugs to prevent infection after open fractures—but no one knows if these expensive treatments actually work or are worth the cost. Open fractures, where bone breaks through the skin, carry high infection risks that can lead to long-term disability and substantial healthcare costs. Surgeons are increasingly using local antibiotics directly at the fracture site, but each dose costs between £750 and £2,250, and overuse could fuel antibiotic resistance. Despite this growing trend, there is no high-quality evidence synthesis comparing clinical effectiveness or cost-effectiveness against standard care. This critical evidence summary will systematically review published trials and economic evaluations to determine whether local antibiotics reduce infection rates and improve quality of life, and whether the benefits justify the price tag. The findings could directly inform updates to NICE guidelines, potentially saving the NHS millions by either endorsing a costly but effective intervention or steering surgeons away from an expensive practice that offers little benefit. If evidence proves insufficient, the review will identify whether ongoing trials can resolve the uncertainty or whether new randomised controlled trials are needed.
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Background Open fractures attract substantial healthcare costs and complications, such as infections, significantly reduce patient quality of life and can result in long-term disabilities. The use of local antibiotics or antibiotic-coated implants as infection prophylaxis in acute fracture surgery is an emerging trend, although the prevalence of current use is not well-documented. Surgeons are interested in reducing infection rates and associated health costs, but local antibiotic formulations are expensive (£750 to £2,250 per dose) and could promote antibiotic resistance. Currently, it is not known if local antibiotics are both clinically and cost-effective in patients undergoing surgery for open fractures. Thus, high-quality evidence synthesis is required to support policy decisions by potentially informing updates to NICE guidelines or prompting further randomised controlled trials (RCTs). Review objectives This critical evidence summary will consist of two complementary evidence summaries with the following objectives: i. To summarise and evaluate existing clinical effectiveness evidence on the use of local antibiotics in patients undergoing surgery for open fractures (Review 1) ii. To summarise and evaluate existing evidence on the cost-effectiveness of local antibiotics compared with no local antibiotics in patients undergoing surgery for open fractures (Review 2). Methods This critical evidence summary will be conducted following the recommendations of the Cochrane Handbook for Systematic Reviews of Interventions and reported in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 checklist. Search strategy For Review 1, extensive searches in MEDLINE, Embase, CINAHL, and Cochrane databases, supplemented by clinical trial registries, will capture published randomised controlled trials. Screening and full-text reviews will follow a structured process, with 40% cross-checked at the title/abstract stage and double screening by independent reviewers at the full-text stage for reliability. For Review 2, the sources searched will be Ovid Medline and Embase, ProQuest EconLit, NHS Economic Evaluation Database, EconPapers (ResPEC), International HTA database, International Society for Pharmacoeconomics and Outcomes Research (ISPOR), and Tufts Medical Center Cost-Effectiveness Analysis (CEA) Registry. Inclusion criteria The critical evidence summary will consider studies on surgery for open fractures of lower limbs, focusing on outcomes such as: • Infection • Health-related quality of life (HRQoL) measured by instruments such as the EQ-5D, • Patient-reported outcome measures of lower limb function applicable to studies involving lower limb surgery. The economic outcomes of interest include: • Health care resource use and costs, • Life years (LYs)/life years gained (LYG), • Quality adjusted life years (QALYs) or QALYs gained, • Incremental cost-effectiveness ratio (ICER) per life year or QALY, • Net health benefit (NHB). Data extraction and presentation For Review 1, data from eligible studies will cover participant details, intervention and comparator, types of surgery and relevant outcomes. Findings will be displayed in tables with descriptive analyses. Due to the expected heterogeneity between studies, formal bias assessment and meta-analysis are not planned. For Review 2, we will tabulate the main characteristics of existing economic evaluations published on the topic and provide a critical interpretation of their findings. Expected outcomes and significance This critical evidence summary aims to assess both published and ongoing studies to provide a comprehensive overview of current research in this area and to determine whether further randomised controlled trials (RCTs) are necessary, or whether ongoing trials may eventually supply sufficient evidence to address the key clinical and policy questions.
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