Surgical Site Infections in Major Lower Limb Amputation: An International Multicentre Audit (SIMBA): Study Protocol

Abstract

Background: Over 3,000 major lower limb amputations (MLLA) occur in the UK per annum. A significant proportion of patients following MLLA will go on to develop a surgical site infection (SSI). SSIs can range from a simple superficial infection that is treated with oral antibiotic therapy to deeper infections which can lead to wound dehiscence and, ultimately, surgical revision. SSIs can have a significant impact on patient mobility, function, morbidity and mortality as well as wider effects on carers, community services and hospital systems. Despite these potential impacts there are limited data to determine the rate of SSI in patients undergoing MLLA, adjuncts that successfully prevent SSI, factors that predispose patients to SSI and compliance with national guidance set out by key stakeholders in vascular surgical care. Methods: To address this gap in evidence we propose a large, international, prospective, collaborative audit that aims to compare current practice against recommendations set out by the National Institute of Health and Care Excellence and The Vascular Society of Great Britain and Ireland and to determine the frequency of significant outcomes related to SSI (as defined by the Centre for Disease Control) in consecutive patients undergoing MLLA over an 8-month period including the incidence of SSI, wound dehiscence and surgical revision at 30 days, frequency of use of adjuncts designed to reduce SSI and predictors of SSI. Outcomes will also be captured at 1 year post-MLLA if funding permits. Discussion: This multicentre audit will allow us to describe the incidence and burden of SSI and wound dehiscence in patients undergoing MLLA. The strengths of this audit will lie in its use of contemporaneous data collection from numerous hospitals and the in-depth data collection focusing primarily on MLLA SSI. It is anticipated that the audit will provide impactful data for future comparisons with global practice and support the design of robust and meaningful studies.