Antibiotic prophylaxis in pacemaker surgery: a prospective double blind trial with systemic administration of antibiotic versus placebo at implantation of cardiac pacemakers.

In a double blind clinical trial, 106 consecutive patients scheduled for pacemaker implantation were randomly assigned either to a systemic prophylaxis group (SPG) (to be given flucloxacillin) or to a control group who would be given a placebo (CPG). The SPG group received 2 g IV flucloxacillin 1 hour before the operation, then 1 g perorally every 8 hours for the next five days. In the CPG group, placebo infusions and tablets were given at the same schedule. There were a total of 106 patients (SPG 52, CPG 54) who met the criteria of the study. Of these, 102 patients (SPG 50, CPG 52) completed a follow-up of 7-35 months. Infection of the pacemaker system was not diagnosed in any patient in either group. Tissue fluid was drawn 24 hours postoperatively from the pacemaker pocket for culture and for determination of pocket antibiotic concentration. The mean flucloxacillin concentration of pocket fluid from 23 patients in the SPG was 7.5 micrograms/ml. The bacteriological cultures were positive in 9/32 patients in the SPG group and in 10/34 patients in the CPG group. This study suggests that antibiotic prophylaxis need not routinely be given at implantation of permanent pacemaker systems.

RCT Entities:   Population Interventions Outcomes