Concept of and preliminary trial protocol for adjuvant treatment of mediastinitis with immunoglobulins after cardiac surgery (ATMI): Response to comments and criticism

During the consensus-based process of protocol development external experts were invited to comment on a proposal for a trial protocol on adjuvant imm unotreatment of patients with wound infection after median sternotomy (ATMI ). Controversies and arguments can be divided into five main areas: 1) rationa le and objectives; 2) criteria for patient selection; 3) adjuvant treatment ; 4) measures of efficacy; and 5) course and timetable of the study. We present and summarise the experts comments and criticism as well as the result of the final discussion of the study group with respect to these are as.