Breast surgery is classified among the procedures performed in clean surgery and is associated with a low incidence of wound infection (3-15%). The objective of this study was to evaluate the advantages antibiotic prophylaxis in patients undergoing breast surgery. A multicenter randomized controlled study was performed between January 2008 and November 2008. One thousand four hundred patients were enrolled in prospective randomized study; surgical wound infection was found in 41 patients (2.93%). In our RCT we have shown that in breast surgery antibiotic prophylaxis does not present significant advantages in patients with potential risk of infection (17 patients, 2.42%, subjected to antibiotic prophylaxis vs 24 patients, 3.43%, without antibiotic prophylaxis) (P = 0.27). In patients with drainage there is a significant minor incidence of wound infections in patients receiving antibiotic prophylaxis (5 patients, 0.92%, subjected to antibiotic prophylaxis vs 14 patients, 3.09%, without antibiotic prophylaxis) (P = 0.02). CONCLUSION: This study is only a preliminary RCT to be followed by a study which should be enrolled more patients in order to get the results as statistically significant
