Ampicillin combined with sulbactam or metronidazole for single-dose chemoprophylaxis in major gynaecological surgery.
A double-blind, placebo-controlled and randomized trial involving a total of 295 patients was carried out to define the role of chemoprophylaxis in major gynaecological surgery in our hospital. Perioperative administration of a single dose of ampicillin (500 mg) plus sulbactam (500 mg) (regimen A), or ampicillin (500 mg) plus metronidazole (1 g suppository) (regimen B), gave similar results. After abdominal hysterectomy, the rates of post-operative wound infection and febrile morbidity were significantly reduced from 24% (12/49) and 20% (10/49) in the placebo group to 3-4% (A = 2/51, B = 3/58) and 2% (A = 1/51, B = 1/58) respectively. After vaginal hysterectomy, pelvic/vaginal infection or febrile morbidity was found in 30% (3/10) of patients in the placebo group but none in either treatment group (A = 10, B = 8). After other types of operation, the rates of infectious complications were reduced, but not statistically significantly, from 11% (4/38) to 4% (A + B 2/71). However, the rates of post-operative urinary tract infection remained similar in the placebo and treatment groups (12-16%).
D000328:Adult; D000667:Ampicillin / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005334:Fever / Q000517:prevention & control; D005831:Genital Diseases, Female / Q000601:surgery*; D006801:Humans; D008795:Metronidazole / Q000627:therapeutic use*; D008875:Middle Aged; D010397:Penicillanic Acid / Q000627:therapeutic use*; D011183:Postoperative Complications / Q000517:prevention & control; D011292:Premedication; D011897:Random Allocation; D013407:Sulbactam; D013530:Surgical Wound Infection / Q000517:prevention & control; D014552:Urinary Tract Infections / Q000517:prevention & control; D065093:beta-Lactamase Inhibitors
D065093:beta-Lactamase Inhibitors; D008795:Metronidazole; D000667:Ampicillin; D010397:Penicillanic Acid; D013407:Sulbactam