[Prophylactic antibiotherapy using cefapirin in the surgery of duodenal ulcer: a randomized clinical trial]

A randomized clinical trial of antibiotic prophylaxis in patients undergoing gastroduodenal surgery for stenosing or bleeding duodenal ulcer was carried out from February 1990 to February 1991. Seventy-two patients were randomly assigned to either Group I (n = 33) and given 1 g of cefapirine intravenously every eight hours, four times, starting at induction of anaesthesia; or to Group II (n = 39), and not given any antibiotic. The surgical dressing was changed on the third postoperative day, and thereafter every two days in patients with fever. The efficiency of prophylaxis was assessed on the incidence of superficial or deep primary infection, and the length of hospital stay. Primary wound sepsis occurred in 7 Group II patients, and in none in Group I (n = 0.01). The results for those patients with stenosing ulcer (n = 53) were also significant: there was no primary wound infection in Group I (n = 25), whereas five occurred in Group II (n = 28) (p = 0.03). Hospital stay was shorter in Group I than in Group II (7 vs 9.5 days). Antibiotic prophylaxis also seemed to be efficient in patients with bleeding duodenal ulcers (n = 19), but their group was too small to reach levels of statistical significance. Again hospital stay was shorter in Group I than in Group II (8.5 vs 12.2 days). The efficiency of antibiotic prophylaxis was therefore confirmed for patients undergoing gastroduodenal surgery for stenosing duodenal ulcer.