Risk Factors for Surgical Site Infection After Lower Limb Revascularization Surgery in Adults with Peripheral Artery Disease: Protocol for a Systematic Review and Meta-Analysis (Preprint)

BACKGROUND Surgical site infections are common, costly, and associated with increased morbidity and potentially mortality after lower limb revascularization surgery (i.e., arterial bypass, endarterectomy, and patch angioplasty). Identifying evidence-informed risk factors for surgical site infection in patients undergoing these surgeries is therefore important. OBJECTIVE We aim to conduct a systematic review and meta-analysis of prognostic studies to identify, synthesize, and determine the certainty in the cumulative evidence associated with reported risk factors for early and delayed surgical site infection after lower limb revascularization surgery in patients with peripheral artery disease. METHODS We will search MEDLINE, EMBASE, the seven databases in Evidence-Based Medicine Reviews, review articles identified during the search, and included article bibliographies. We will include studies of adults (≥18-years-of-age) with peripheral artery disease that reported odds ratios, risk ratios, or hazard ratios adjusted for the presence of other risk factors or confounding variables and relating the potential risk factor(s) of interest to development of surgical site infection after lower limb revascularization surgery. We will exclude studies that did not adjust for confounding, exclusively examined certain high-risk patient cohorts, or included >20% of patients who underwent surgery for indications other than peripheral artery disease. The primary outcomes will be early (in-hospital or ≤30-day) surgical site infection and Szilagyi grade I (cellulitis involving the wound), grade II (infection involving subcutaneous tissue), and grade III (infection involving the vascular graft) surgical site infection. Two investigators will independently extract data and evaluate study risk of bias using the Quality in Prognosis Studies tool. Adjusted risk factor estimates with similar definitions will be pooled using DerSimonian and Laird random-effects models. Heterogeneity will be explored using stratified meta-analyses and meta-regression. Finally, we will use the Grading of Recommendations, Assessment, Development, and Evaluation approach to determine certainty in the estimates of association between the reported risk factors and development of surgical site infection. RESULTS The protocol was submitted to PROSPERO, the international register of systematic reviews, on March 12, 2021. CONCLUSIONS This study will identify, synthesize, and determine the certainty in the cumulative evidence associated with risk factors for early and delayed surgical site infection after lower limb revascularization surgery in patients with peripheral artery disease. Results will be used to inform practice, clinical practice statements and guidelines, and subsequent research. CLINICALTRIAL Submitted to PROSPER on March 12, 2021.