SUMMARY A prospective trial was conducted to assess the value of prophylactic antibiotic treatment in preventing postoperative infection of permanent transvenous pacemaker systems. Four hundred and thirty-one patients were randomly allocated to treatment (234) or no-treatment (197) groups. Treated patients received systemic benzylpenicillin and flucloxacillin just before operation and one and six hours afterwards.Nine primary generator pocket infections occurred without evidence of wound dehiscence or skin erosion. Seven infections were in untreated patients and two in treated patients. Antibiotic prophylaxis diminishes the risk of infection after pacemaker implantations.Pacemaker generator pocket infection has remained a major complication of implantation since the first units were used 25 years ago. Sepsis rates in recent series have varied between 0-3%1 and 12-6%.2It is common practice to employ prophylactic antibiotic treatment at the time of implantation in the expectation that the number of infections will be reduced. Some retrospective analyses of uncontrolled series have supported this view3 but Siddons and Nowak4 have suggested that the protective effect is small. Furthermore there is no uniformity of practice in the use of antibiotics. In these circumstances there was clearly a need for a prospective trial to evaluate the effectiveness of prophylactic antibiotic treatment at the time of pacemaker implantation.
SubjectsWe studied all patients who underwent elective permanent pacemaker implantation (new systems) non-elective reoperations, such as the repositioning of previously implanted electrodes, were studied separately.Four hundred and thirty-one patients were randomly allocated to treatment or no-treatment groups with the single exception of 13 patients who reported allergy to penicillin and who did not receive antibiotics. The patients were allocated according to the last digit of their hospital record number: odd numbers received treatment and even numbers did not.The antibiotic regimen was: flucloxacillin 1 g together with benzylpenicillin 600 mg intramuscularly, one hour before operation one hour and six hours after operation.All operations were carried out under local anaesthesia after premedication with either intravenous diazepam or morphine sulphate and droperidol. All procedures took place in the same operating theatre using standard instrument packs, and aseptic technique. This theatre was used on other occasions for minor surgical procedures. Chlorhexidine 4% was used for hand cleansing. Providoneiodine 10% aqueous solution was used for skin preparation on the night before the operation and on the morning of operation, and was followed by providone-iodine 7-5% with surfactants at the time of operation.5 All new systems consisted of standard intravenous electrodes attached to subcutaneous or subfascial generators. Cephalic, perctoral,6 539 on 9 May 2018 by guest. Protected by copyright.