Antimicrobial Prophylaxis in Laparotomic Gynecologic Surgery: a Prospective Randomized Study Comparing Amoxicillin-Clavulanic Acid with Cefazolin

Abstract

A prospective randomized study was conducted at the Department of Obstetrics and Gynecology, University of Bari to compare two antimicrobial regimens, amoxicillin-clavulanic acid with cefazolin as ultra-short term prophylaxis in laparotomic gynecologic surgery. Patients were randomly allocated to receive a single dose of amoxicillin-clavulanic acid (2.2 g) [Group A] or cefazolin (2 g) [Group B] 30 minutes before surgery. Each patient was assessed daily until discharge for fever and the presence of infection of the surgical wound, urinary tract and respiratory tract. In the amoxicillin-clavulanic acid (Group A) and cefazolin (Group B) groups, overall 258 and 253 patients, respectively were evaluable for prophylactic efficacy at hospital discharge. Infectious complications were infrequent in both arms. Febrile morbidity occurred in 16 (6.3%) and 21 (8.1%) patients respectively in the amoxicillin-clavulanic acid and cefazolin groups. Wound infection and urinary tract infection were also higher but not significantly in the cefazolin group (0.8% versus 0% and 2.7% versus 2.0% respectively). There was no respiratory tract infection or septic death in either group. It is concluded that ultra-short term prophylaxis with both amoxicillin-clavulanic acid and cefazolin is safe and effective in elective laparotomic gynecologic surgery.

Clinical practice guidelines for antimicrobial prophylaxis in surgery

“…Studies comparing single doses of one antimicrobial with multidose regimens of a different antimicrobial have shown the two regimens to be equally effective in reducing the postoperative infection rate in women undergoing vaginal and abdominal hysterectomies. [635][636][637][638][639][640][641][642][643][645][646][647][648][649][650][655][656][657][658][659][660][661][662][663] The limited comparative trials involving single-dose cefazolin 637,654,655,664 or ampicillin-sulbactam 654,663 indicate that a single dose of antimicrobial is sufficient prophylaxis for SSIs for vaginal hysterectomy. Single doses of cefotetan, ceftizoxime, or cefotaxime appear to be as effective as multiple doses of cefoxitin.…”

“…[644][645][646][647][648][649]665 A second dose of antimicrobial is warranted when the procedure lasts three hours or longer or if blood loss exceeds 1500 mL. 9,654 Recommendation. The recommended regimen for women undergoing vaginal or abdominal hysterectomy, using an open or laparoscopic approach, is a single dose of cefazolin (Table 2).…”

“…administered 20-30 minutes before the procedure. 654 A second dose was given if the surgery lasted over three hours or there was extensive blood loss (>1500 mL). No significant differences in the rates of any postoperative infection, including SSIs, were found between groups.…”

Increased incidence of postoperative infections during prophylaxis with cephalothin compared to doxycycline in intestinal surgery

“…The incidence in unselected patient series, including urgent operations, patients with concurrent disease, patients in whom preoperative infections were suspected and patients with treatment failures is not known. Moderate size surgical procedures, such as small intestinal surgery and hysterectomies are followed by postoperative infection rates around 5% to 10%, or lower in selected elective cases [6-9]. About one half of the SSI becomes evident after discharge and the surgeons often do not know the true infection rate [1,10].…”

Antibiotic Prophylaxis in Gynecology, Oncology and Surgical Procedures a Brief up-to Date

“…Several recommendations for antibiotic prophylaxis have been reported; the majority of authors recommend the administration of cephalosporin's which have broad spectrum coverage and half-life, especially cefazolin combined with metronidazole in cases where bowel resection maybe applied [4]. Cefazolin can be considered as alternative regimen in patients with penicillin allergy, furthermore other agents can be given such as clindamycin, gentamycin, erythromycin etc [4].…”