[Pefloxacin versus ceftriaxone in single-dose antibiotic prophylaxis in general clean-contaminated surgery. The Pefloxacin Study Group].
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.
Montorsi
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Scuola di Specializzazione in Chirurgia dell'Apparato Digerente ed Endoscopia Digestiva Chirurgica, Università degli Studi, Milano.
Germiniani
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D000293:Adolescent; D000328:Adult; D000368:Aged; D000890:Anti-Infective Agents / Q000008:administration & dosage*; D019072:Antibiotic Prophylaxis / Q000379:methods* / Q000706:statistics & numerical data; D002443:Ceftriaxone / Q000008:administration & dosage*; D002511:Cephalosporins / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged; D015366:Pefloxacin / Q000008:administration & dosage*; D013514:Surgical Procedures, Operative / Q000379:methods* / Q000706:statistics & numerical data; D013530:Surgical Wound Infection / Q000517:prevention & control
D000890:Anti-Infective Agents; D002511:Cephalosporins; D015366:Pefloxacin; D002443:Ceftriaxone