[Pefloxacin versus ceftriaxone in single-dose antibiotic prophylaxis in general clean-contaminated surgery. The Pefloxacin Study Group]

Abstract

Single-shot surgical prophylaxis is today used in all clean-contaminated surgery, because it is able to reduce the incidence of post-surgical infections. The aim of this clinical trial is to evaluate the efficacy of Pefloxacin 800 mg i.v. slow infusion in single administration 1-2 hours before surgery versus ceftriaxone 2 g i.v. 1-2 hours before surgery in 297 patients suffering from clean-contaminated surgery, especially biliary surgery and gastrectomy. Efficacy of prophylaxis in 259 patients, evaluable according to the protocol, was evaluated in terms of appearance of post-surgical infections (urinary, respiratory and wound infections). In the Pefloxacin group (128 patients), no cases of wound infections were observed, except one case of wound sterile secretion, without dehiscence, (0.81%), one case of urinary infection (0.81%) and three cases of respiratory infections (2.34%). In the ceftriaxone group (131 patients), three cases of wound sterile secretion without dehiscence (2.36%), one case of urinary infections (0.76%) and four cases of respiratory infections (3.05%) were observed. From this study we can conclude that single-shot surgical prophylaxis with pefloxacin, drug with microbiological and pharmacokinetics characteristics suitable for prophylaxis, is able to prevent postsurgical nosocomial infections as well as ceftriaxone, considered a reference drug largely used in this indication.