Reduction of infection after cardiac surgery: a clinical trial.

Between January 1, 1975, and June 1, 1984, 3,275 patients underwent cardiac operations with cardiopulmonary bypass. No operations were performed in 1978. In Phase I of the study, general operating rooms were used for cardiac operations, and standard methods of antisepsis and asepsis were used. Phase II began in January, 1979, with the opening of two specially constructed operating rooms with complete separation of incoming and outgoing personnel and supplies, and with a laminar airflow system. All personnel scrubbed 3 minutes and changed into autoclaved clothing before entering the operating suite, and scrubbed again for 5 minutes before putting on gowns. By Phase III, which began in July, 1982, all additional protocols against infection were in place including strict techniques in the intensive care unit and a continuous antiinfection surveillance program. In Phase I, 7.3% (70% confidence limits [CL] 6.4 to 8.2%) of patients had an infectious complication; in Phase II, 2.7% (CL 2.3 to 3.2%), and in Phase III, 0.8% (CL 0.5 to 1.2%). The reductions were similar in the four subtypes of infection (superficial presternal infection, mediastinitis, endocarditis, and septicemia). The study indicates that improving the surgical environment, improving the surgical and operating room protocols, and increasing the awareness of the dangers of infection among the personnel can strikingly reduce the incidence of infections after cardiac operations.