Effect of ultraclean air in operating rooms on deep sepsis in the joint after total hip or knee replacement: a randomised study.

In a multicentre study of sepsis after total hip or knee replacement the operations performed by each surgeon were allocated at random between control and ultraclean-air operating rooms. Records were obtained from over 8000 such operations. In the patients whose prostheses were inserted in an operating room ventilated by an ultraclean-air system the incidence of joint sepsis confirmed at reoperation within the next one to four years was about half that of patients who had had the operation in a conventionally ventilated room at the same hospital. When whole-body exhaust-ventilated suits had been worn by the operating team in a theatre ventilated by an ultraclean-air system the incidence of sepsis was about a quarter of that found after operations performed with conventional ventilation. When all groups in the trial were considered together the analysis showed deep sepsis after 63 out of 4133 operations in the control group (1.5%) and after 23 out of 3922 operations in the ultraclean-air groups (0.6%) (ratio 2.6, 95% confidence limits 1.6-4.2; p less than 0.001). The design of the study did not include a strictly controlled test of the effect of prophylactic antibiotics, but their use was associated with a lower incidence of sepsis than in patients who had received no antibiotic prophylaxis at their operations (0.6% (34/5831) v 2.3% (52/2221); ratio 4.0).