OBJECTIVES: To conduct a systematic review of literature on the epidemiological and economic burden of surgical site infection (SSI) in Japan.METHODS: A literature search of the EMBASE and Medline databases was conducted. The search was limited to 1995–2010 to ensure the pertinence of the data. Searches to identify epidemiological and economic studies were conducted separately. Relevant studies were identified using pre-defined criteria (ie, reports the rate, risk factors, cost of SSI; conducted in a hospital setting; not an intervention study). RESULTS: Thirty-five studies (22 retrospective, 12 prospective and one case-control study) were included. Differences in study design, surgical procedure and surveillance period made it difficult to synthesise data to derive a single estimate of SSI in Japan. The overall incidence of SSI in Japan is approximately 5–10%. The rate of SSI was higher following gastrointestinal surgery (~20%), and lower for cardiovascular (<6.5%) and orthopaedic (<1%) surgery. Superficial SSI occurred most frequently accounting for 30–87% of all SSIs. The National Nosocomial Infections Surveillance (NNIS) risk index was positively correlated with the risk of developing an SSI. Procedure-associated risk factors (e.g. surgical technique, surgery duration) were also found to significantly increase the risk of SSI. The most common organisms identified in SSIs were Staphylococcus aureus and Pseudomonas aeruginosa. None of the studies identified in this review examined the economic burden of SSI in Japan. However, several studies showed that SSIs were associated with a significant increase in ICU and hospital stay (6–27 additional days). CONCLUSIONS: SSI represents a substantial burden on the health care system and patients, mainly attributable to the extended length of stay in hospital and additional cost of treatment required. Consequently, strategies and interventions aimed at reducing the incidence of SSIs could provide cost-savings and improve the efficiency of the Japanese health care system.