Prospective randomized study comparing amoxicillin-clavulanic acid with cefazolin as antimicrobial prophylaxis in laparotomic gynecologic surgery.
BACKGROUND
To compare amoxicillin-clavulanic acid with cefazolin as ultra-short-term prophylaxis in laparotomic gynecologic surgery.


METHODS
A prospective randomized study was conducted to compare two antimicrobial regimens in surgical prophylaxis of laparotomic surgery. Patients were randomly allocated to receive amoxicillin-clavulanic acid (2.2 g) [Group A] or cefazolin (2 g) [Group B] as a single dose 30 min before surgery. Each patient was assessed daily until discharge to evidence febrile status and the presence of infections at the operative site, urinary tract, and respiratory tract.


RESULTS
In the amoxicillin-clavulanic acid (Group A) and cefazolin (Group B) groups, overall 346 and 352 patients, respectively, were evaluable for prophylactic efficacy at hospital discharge. Infectious complications were infrequent in both arms. Febrile morbidity occurred in 21 (6.1%) and 26 (7.4%) 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 (0.5% vs. 1.1% and 2.0% vs. 2.5%, respectively). There was one respiratory tract infection (0.2%) in Group B, and no septic death in either groups.


CONCLUSIONS
Ultra-short-term prophylaxis with both amoxicillin-clavulanic acid and cefazolin is safe in elective laparotomic gynecologic surgery.
Cormio
Gennaro
G
Sezione di Ginecologia A, Dipartimento di Scienze Chirurgiche Generali e Specialistiche, Università degli Studi di Bari, Italy. n.cormio@gynecology2.uniba.it
Di Fazio
Franco
F
Cacciapuoti
Cinzia
C
Bettocchi
Stefano
S
Borraccino
Luisella
L
Selvaggi
Luigi
L
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019980:Amoxicillin-Potassium Clavulanate Combination / Q000008:administration & dosage*; D019072:Antibiotic Prophylaxis; D002437:Cefazolin / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D005831:Genital Diseases, Female / Q000175:diagnosis / Q000601:surgery; D013509:Gynecologic Surgical Procedures / Q000009:adverse effects / Q000379:methods; D006801:Humans; D007813:Laparotomy / Q000009:adverse effects* / Q000379:methods; D008875:Middle Aged; D011183:Postoperative Complications / Q000517:prevention & control*; D011300:Preoperative Care / Q000379:methods; D011336:Probability; D011446:Prospective Studies; D018570:Risk Assessment; D013530:Surgical Wound Infection / Q000517:prevention & control; D016896:Treatment Outcome
D019980:Amoxicillin-Potassium Clavulanate Combination; D002437:Cefazolin