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Prophylaxis in gynaecological and obstetric surgery: a comparative randomised multicentre study of single-dose
1Dipartimento di Farmacologia Preclinica e Clinica, University of Florence, Italy.
Abstract:
Antimicrobial prophylaxis is recommended in all clean-contaminated surgery where the critical threshold of number and virulence of the contaminating organisms with respect to host resistance is reached. Obstetric and gynaecological surgery is clean-contaminated and risk of infection due to aerobic and anaerobic bacteria without prophylaxis can be quantified at 30-40% for vaginal hysterectomy, 10-35% for abdominal hysterectomy and 10-34% for caesarean section. To assess the role of two different cephalosporins as short term prophylaxis, we carried out a multicentre randomised study involving a single 2 g i.v. dose of cefotetan in comparison with two doses of cefazolin (2 g i.v. before surgery and after 8 hours). Criteria for exclusion were: exposure to antibiotics within 7 days, preoperative infection, hypersensitivity to beta-lactams. Four hundred and sixty patients entered the study, of which 229 received cefotetan and 231 cefazolin. No significant differences in mean age, obesity, preoperative weight loss, diabetes, type of disease, type of surgery (vaginal or abdominal hysterectomies and caesarean sections) and number of pregnancies and abortions existed between the two groups of patients. The total rate of infected patients undergoing hysterectomy was 8.6% (13/151) in the cefotetan group and 17.4% (29/167) in the cefazolin group (p less than 0.05). This difference was due to cases of symptomatic bacteriuria and antibiotic retreatment, while wound infections were not significantly different (2.6% and 1.8% respectively). Among patients undergoing caesarean section, 9 of 78 (11.5%) and 7 of 64 (10.9%) were infected following cefotetan and cefazolin, respectively (not significant). Cefotetan mean tissue concentrations in gynaecological organs were higher than those of cefazolin (25.5-44.8 vs. 7.4-9.5 mg/kg).(ABSTRACT TRUNCATED AT 250 WORDS)
Insights
In gynecological surgery, cefotetan demonstrated superior efficacy over cefazolin in preventing infections. This study highlights cefotetan
Area of Science:
- Infectious Diseases
- Pharmacology
- Obstetrics and Gynecology
Background:
- Clean-contaminated surgery, including obstetric and gynecological procedures, carries a significant risk of infection without antimicrobial prophylaxis.
- Established infection rates range from 30-40% for vaginal hysterectomy, 10-35% for abdominal hysterectomy, and 10-34% for cesarean sections.
- Short-term antimicrobial prophylaxis is recommended to mitigate these risks.
Purpose of the Study:
- To evaluate the efficacy of cefotetan compared to cefazolin as short-term antimicrobial prophylaxis in obstetric and gynecological surgery.
- To assess the impact of different dosing regimens on postoperative infection rates.
Main Methods:
- A multicenter randomized study involving 460 patients undergoing hysterectomy or cesarean section.
- Patients received either a single 2g IV dose of cefotetan or two doses of cefazolin (2g IV pre-op and 8 hours post-op).
- Exclusion criteria included recent antibiotic exposure, preoperative infection, or beta-lactam hypersensitivity.
Main Results:
- The overall infection rate for hysterectomy patients was significantly lower in the cefotetan group (8.6%) compared to the cefazolin group (17.4%) (p<0.05).
- This difference was primarily driven by reduced symptomatic bacteriuria and need for antibiotic retreatment; wound infection rates were similar.
- No significant difference in infection rates was observed between the two groups for cesarean section patients (11.5% cefotetan vs. 10.9% cefazolin).
Conclusions:
- Cefotetan, as a single-dose prophylaxis, is more effective than a two-dose regimen of cefazolin in reducing overall infections following hysterectomy.
- Higher cefotetan tissue concentrations in gynecological organs may contribute to its enhanced efficacy.
- Further research may be warranted to optimize prophylaxis strategies for cesarean sections.