Antibiotic prevention of infections complicating radical abdominal hysterectomy

In this randomized, double-blind study, the effectiveness of a single-agent prophylactic antibiotic in reducing infections after radical abdominal hysterectomy with pelvic and para-aortic lymphadenectomy was compared with a placebo. A total of 12 doses of cefoxitin (2g) or placebo were given to 70 patients, starting the evening before surgery. Because of tumor spread beyond the cervix, radical hysterectomy was not performed in 17 patients who were, therefore, excluded from the study. Analysis of 53 patients who completed the study revealed that 15% of cefoxitin patients had surgical site-related infections compared with 52% of placebo patients (P = .005). Significant differences between the groups were also observed in nonsurgical site-related infections (23 versus 48%), overall morbidity (58 versus 89%), and the need for additional antibiotic therapy (38 versus 67%). Socioeconomic status was a significant risk factor with 57% of staff patients demonstrating increased site-related infections as compared with 17% of private patients (P = .002). No clinically significant side effects were observed. The authors recommend the use of antibiotic prophylaxis in patients undergoing radical abdominal hysterectomy for gynecologic malignancies.     

Postoperative infections and antibiotic prophylaxis in radical hysterectomy. Retrospective study]

Radical hysterectomy is associated with a high risk of postoperative infectious morbidity. A series of 73 patients who underwent abdominal radical hysterectomy with pelvic lymphadenectomy is presented. Hospital charts were reviewed to determine the influence of surgical characteristics and of different antibiotic prophylaxis regimens on postoperative septic complications. The overall incidence of postoperative infections was 31.5%; in 13 patients had urinary tract infections (17.7%), 3 surgical site-related infections (4.1%) and 6 febrile morbidity (8.2%). There were also 3 cases of phlebitis and 3 infectious events at distant sites. No interaction was observed between the examined risk factors and the overall infectious morbidity. Time of surgical procedure and average blood transfusion show a trend toward increased values in patients with complications compared to patients with regular postoperative course. The most important current controversy about the use of prophylaxis in radical hysterectomy concerns the duration of postoperative treatment. In this series the major part of the subjects received a long-term antibiotic prophylaxis regimen (greater than 72 hours), and only 18% received a perioperative prophylaxis. Women without postoperative complications were more frequently treated with a long-term antibiotic prophylaxis (82%) compared to women with infectious morbidity (65%). Moreover, in patients with complications, the proportion of cases who needed an additional antibiotic therapy was lower in the group receiving long-term prophylaxis (20%) compared to the short-term group (83%).     

Single- versus three-dose cefoxitin prophylaxis in caesarean section: a randomized clinical trial

The present study was undertaken to determine the minimal effective antibiotic dosage in caesarean section prophylaxis. The study was conducted at the Academisch Ziekenhuis der Vrije Universiteit in Amsterdam (Amsterdam Free University Hospital) to compare the efficacy of one dose of cefoxitin (2 g) with three administrations of 2, 1 and 1 g respectively. In this prospective and double-blind study, 66 patients were given one dose and 72 patients received three doses. In terms of febrile morbidity, endometritis, wound infection, urinary tract infection and need for postoperative antibiotic therapy, the three-dose group showed fewer postoperative infections: as to wound infections (p less than 0.05) and therapeutic antibiotic use (p less than 0.025) these differences were statistically significant. The numbers of days of hospitalization after the caesarean section also showed differences: 10.6 +/- 2.6 versus 9.8 +/- 1.5 days in the one- and three-dose groups respectively (p less than 0.05). It is concluded that, contrary to several reports in the literature, prophylaxis consisting of three administrations of cefoxitin is to be preferred. No significant allergic or adverse reactions were observed in our patients.     

Efficacy and safety of two cephalosporins in the perioperative prophylaxis in patients undergoing abdominal or vaginal hysterectomies or gynaecological laparotomies: a prospective randomized study

The aim of this study was to compare efficacy and safety of perioperative antibiotic prophylaxis in patients undergoing abdominal or vaginal hysterectomy or gynaecological laparotomy to improve the prevention of surgical wound infections. One hundred and ninety-nine patients were prospectively randomized into two groups: the first group (n = 100) received perioperative prophylaxis using 1 g cefotiam (Spizef) and 0.5 g metronidazole (Clont) intravenously 30 min before surgery, whereas the second group (n = 99) was treated with 2 g cefoxitin (Mefoxitin) intravenously, also 30 min before surgery. The efficacy of the perioperative antibiotic prophylaxis was assessed clinically and on the basis of laboratory parameters. No wound infections were observed in 97 patients (97%) of the cefotiam-treated group and in 94 patients (94%) of the cefoxitin-treated group. No systemic postoperative infections were observed in 81% of the patients treated with cefotiam combined with metronidazole and in 85% of the patients treated with cefoxitin. The good tolerability of the drugs administered was proven in 98% of the patients treated with cefotiam and metronidazole and in 97% of the patients treated with cefoxitin. In both groups 3 patients developed nausea and/or vomiting, respectively, due to the antibiotic prophylaxis. A low infection rate after gynaecological surgery was observed. Cefotiam as a low dosage combined with metronidazole was as effective as cefoxitin. Cephalosporins of the second generation in combination with metronidazole can, therefore, be considered effective and safe drugs in the prevention of postsurgical infections.     

Single-dose cefotetan versus multidose cefoxitin for prophylaxis in cesarean section in high-risk patients

A prospective, randomized, open trial of a single intravenous dose of a new broad-spectrum and long-acting cephalosporin was compared with the effect of three doses of cefoxitin in a group of 70 women undergoing cesarean section who were at high risk for postoperative endomyometritis and wound infection. All patients either had ruptured membranes or were in active labor, or both, without clinically detectable chorioamnionitis at the time of prophylaxis. Forty-six women received a single 2 gm dose of cefotetan and 24 received 2 gm of cefoxitin every 4 hours to complete a three-dose regimen. Outcomes of infectious febrile morbidity due to endomyometritis (15% versus 8%), wound erythema (4% versus 12%), and other parameters were similar for cefotetan and cefoxitin, respectively. Both agents were well tolerated in this high-risk population. Within the limits of this study, single-dose cefotetan chemoprophylaxis appears to be comparable to multidose cefoxitin administration in reducing morbidity in operative site infections after cesarean section.     

The selective use of vaginal hysterectomy in the management of adenocarcinoma of the endometrium

A prospective, blinded, placebo-controlled study was performed to determine the minimum effective duration of short-term antibiotic prophylaxis following cesarean section. Cefoxitin was selected as the study drug, and 189 women at high risk for postoperative infectious morbidity were randomly assigned to three cohorts, each receiving intravenous infusions at cord clamping and at 4 and 8 hours postoperatively. The incidence of endometritis in the placebo group was 29.3% versus 9.4% in patients receiving one dose of cefoxitin (2 gm) at cord clamping and 5.0% in patients receiving three doses of cefoxitin (p less than 0.0001). Cefoxitin prophylaxis significantly reduced the incidence of endometritis in patients with postoperative anemia. There were no serious complications or drug reactions in the treated groups.     

Cefotetan versus cefoxitin as prophylaxis in hysterectomy

Seventy hospitalized women were entered into an open, randomized, parallel study of antimicrobial prophylaxis for abdominal and vaginal hysterectomy with the use of either cefotetan, a new long-acting cephalosporin, or cefoxitin. Ninety-four percent of cefotetan recipients and 83% of cefoxitin recipients did not develop clinical signs or symptoms of infection. The satisfactory bacteriologic response rates were significantly different: 91% satisfactory (43 of 47 patients) for cefotetan and 74% satisfactory (17 of 23 patients) for cefoxitin. The two treatment groups demonstrated no significant differences in postoperative temperature changes, duration of hospitalization, or grading of surgical wounds. Neither drug was associated with significant side effects.     

Comparison of cefotetan and cefoxitin as prophylaxis in cesarean section

A study comparing the efficacy of cefotetan versus cefoxitin for prophylaxis in patients undergoing cesarean section was carried out at the University of Iowa. After institutional review, 36 subjects who met the study criteria and agreed to participate were entered into the study; of these, 29 were evaluable for efficacy. Twenty subjects received a single 2 gm dose of cefotetan, and nine subjects received three 2 gm doses each of cefoxitin. Both antibiotics were administered intravenously at the time the umbilical cord was clamped. The subsequent doses of cefoxitin were given intravenously at four and eight hours after the initial dose. Clinical and bacteriologic responses were evaluated; there were no statistically significant differences between the two groups, and both antibiotics provided effective prophylaxis against infection. It appears that cefotetan is a satisfactory antibiotic choice for cesarean section prophylaxis. Further, in this small study it appears that a single dose of cefotetan is as effective as three doses of cefoxitin. This implies that cefotetan would not only decrease administration time and supplies but would decrease the cost to the patient while maintaining very acceptable infection rates.     

Randomized double-blind comparison of mezlocillin versus cefoxitin prophylaxis for vaginal hysterectomy

One hundred patients undergoing vaginal hysterectomy were enrolled in a randomized double-blind comparative antibiotic prophylaxis study. Forty-six patients received mezlocillin and 54 patients received cefoxitin. No significant difference was found among patients who developed febrile morbidity. Failure rate for mezlocillin was 17 per cent and for cefoxitin, 15 per cent. There was an increase in colonization of Streptococcus faecalis and Enterobacter species in patients receiving three doses of cefoxitin prophylaxis.     

Prophylactic transfusion in sickle cell disease

This prospective study was designed to compare the relative efficacy of two antibiotic regimens for the treatment of operative site infections subsequent to pelvic operations. Patients with endomyoparametritis after delivery or pelvic cellulitis subsequent to hysterectomy were randomized to treatment with the combination of penicillin-gentamicin or the single agent cefoxitin. Seventeen of the 26 patients (65%) with endomyoparametritis who were treated with penicillin-gentamicin were cured by antibiotic therapy alone, in comparison to 15 of 23 (65%) patients treated with cefoxitin. Fifty-eight percent of the patients with pelvic cellulitis who were treated with penicillin-gentamicin responded favorably, in comparison to 50% of the patients treated with cefoxitin. None of these differences was statistically significant. In this study, neither antibiotic regimen provided satisfactory initial treatment for surgically induced soft tissue pelvic infection. Moreover, 11 of the 28 patients with treatment failures (40%) developed serious sequelae of their primary infection.     

A prospective randomized trial of ampicillin/sulbactam vs cefoxitin prophylaxis for radical gynecologic surgery

The objective of this study was to compare the effectiveness of ampicillin/sulbactam vs cefoxitin for the prevention of postoperative febrile morbidity and operative site infection in patients undergoing radical surgery for gynecological malignancies and to evaluate the occurrence of Clostridium difficile toxin-associated colitis in patients receiving these prophylactic antibiotics. A prospective randomized trial of 150 patients, 75 receiving ampicillin/sulbactam and 75 receiving cefoxitin. No significant differences in patient characteristics, preoperative risk factors or surgical characteristics were detected between the two groups. Twenty-one of 75 patients (28%) receiving ampicillin/sulbactam developed febrile morbidity compared with 31 of 75 patients (41%) receiving cefoxitin. Surgical site infection (3% vs 5%) and nonsurgical site infections (13% vs 12%) were comparable. Four patients (5%) treated with cefoxitin developed C. difficile toxin-associated colitis vs no patients treated with ampicillin/sulbactam. Ampicillin/sulbactam prophylaxis is comparable to cefoxitin in prevention of surgical site infection but is not associated with C. difficile toxin-associated colitis.     

Amoxycillin-clavulanic acid (Augmentin) versus metronidazole as prophylaxis in hysterectomy: a prospective, randomized clinical trial

Summary. In order to determine the most effective regimen for the prevention of infection after elective hysterectomy, 300 patients were randomly assigned to receive three perioperativc doses of either amoxycillin-clavulanic acid (1.2 g intravenous) or metronidazole (1 g suppository). Of the 280 patients who were assessable 138 were given amoxycillin-clavulanic acid and 142 received metronidazole; 268 underwent abdominal hysterectomy and 12 had vaginal hysterectomy. Patients in the amoxycillin-clavulanic acid group had significantly less infectious morbidity (13.8%) than those in the metronidazole group (33.1%). There were also statistically significant differences in favour of amoxycillin-clavulanic acid with respect to operative site infection, duration of hospital stay, need for postoperative antimicrobials, and surgery for operative site infection. But for one isolate of Bacteroides fragilis , all pathogens isolated from wound infections in the metronidazole group were aerobes. No anaerobes were isolated from patients in the amoxycillin-clavulanic acid group. The results suggest that prophylaxis for hysterectomy should consist of an agent, or combination of agents, with activity against both aerobic and anaerobic bacteria. Amoxycillin-clavulanic acid fulfils this criterion and appears to be effective and safe.     

Amoxycillin-clavulanic acid (Augmentin) versus metronidazole as prophylaxis in hysterectomy: a prospective, randomized clinical trial

In order to determine the most effective regimen for the prevention of infection after elective hysterectomy, 300 patients were randomly assigned to receive three perioperative doses of either amoxycillin-clavulanic acid (1.2 g intravenous) or metronidazole (1 g suppository). Of the 280 patients who were assessable 138 were given amoxycillin-clavulanic acid and 142 received metronidazole; 268 underwent abdominal hysterectomy and 12 had vaginal hysterectomy. Patients in the amoxycillin-clavulanic acid group had significantly less infectious morbidity (13.8%) than those in the metronidazole group (33.1%). There were also statistically significant differences in favour of amoxycillin-clavulanic acid with respect to operative site infection, duration of hospital stay, need for postoperative antimicrobials, and surgery for operative site infection. But for one isolate of Bacteroides fragilis, all pathogens isolated from wound infections in the metronidazole group were aerobes. No anaerobes were isolated from patients in the amoxycillin-clavulanic acid group. The results suggest that prophylaxis for hysterectomy should consist of an agent, or combination of agents, with activity against both aerobic and anaerobic bacteria. Amoxycillin-clavulanic acid fulfils this criterion and appears to be effective and safe.     

Perioperative use of cefoxitin in primary cesarean section

We performed a randomized, double-blind trial on a relatively low-risk population comparing the use of three doses of cefoxitin vs. placebo in the prevention of infection following primary cesarean section. Major site-related morbidity (endometritis, wound infection and septicemia) was significantly reduced in the cefoxitin group (8.9% vs. 27.8%; p = 0.017). Febrile morbidity alone tended to occur in the cefoxitin group (15.6% vs. 3.7%; p = 0.091), and all five urinary tract infections occurred in the cefoxitin group as well. Total morbidity was therefore not significantly different (cefoxitin, 35.6%; placebo, 31.5% [not significant]). Duration of hospitalization (mean, 6.0 days) and need for further postoperative antibiotic therapy were similar in the two groups. Our study demonstrated a modest benefit from the perioperative use of antibiotics in relatively low-risk patients undergoing primary cesarean section. Issues that need further study include definition of the optimal prophylactic regimen and of high-risk populations for whom prophylaxis would be most helpful.     

A comparison of cefonicid and cefoxitin for preventing infections after vaginal hysterectomy

One hundred women who underwent vaginal hysterectomy were randomly and prospectively divided into two study groups, one to receive a single, 1-g preoperative dose of cefonicid and the other to receive 2 g of cefoxitin preoperatively and postoperatively for a total of four doses. There were no differences between the two groups in the rates of febrile morbidity, urinary tract infection, serious infection, noninfectious morbidity or duration of hospitalization. Both cefonicid and cefoxitin were equally effective in preventing postoperative infectious morbidity and demonstrated little difference in side effects. The single-dose regimen of cefonicid provides the advantages of decreased cost and prolonged therapeutic tissue levels when compared to cefoxitin. Perioperative antimicrobial prophylaxis with this single-dose cephalosporin provides a cost-effective regimen that is both safe and prophylactically effective.     

Single-dose antibiotic prophylaxis in high-risk patients undergoing cesarean section. A comparative trial

A prospective, double-blind study was performed to evaluate the comparative efficacy of single- and multiple-dose antimicrobial prophylaxis for preventing infection in high-risk patients undergoing cesarean section. One hundred fifty-eight patients were randomly assigned to receive either a single perioperative dose of mezlocillin, three doses of mezlocillin or three doses of cefoxitin. The incidence of endometritis was 5.9%, 4.0% and 4.0%, respectively. The incidence of febrile morbidity was 5.9%, 2.0% and 6.1%, respectively. These differences are not statistically significant. The single perioperative dose of mezlocillin was as effective as the three-dose regimen of either mezlocillin or cefoxitin.     

Single-dose cefoxitin prophylaxis for premenopausal women undergoing vaginal hysterectomy

A prospective randomized blinded study was conducted comparing a single 2-g preoperative dose of cefoxitin with three 2-g doses of cefoxitin over 12 hours given to premenopausal women scheduled for vaginal hysterectomy in Parkland Memorial Hospital. The incidence of major pelvic infection in 58 women given one dose was 1.7%, and it was 3.7% for 54 women given three doses. The mean hospital stay (4.5 days) was similar for both regimens; for those who developed major infection it was eight days. More aerobic bacteria with altered species dominance and fewer anaerobic bacteria were recovered from the vaginal cuff at discharge from the hospital when compared with those recovered from the endocervix preoperatively. There was a trend toward increasing minimal inhibitory concentrations to cefoxitin in bacteria isolated after surgery, which was more frequent in women given three doses. There was not a statistically significant intergroup difference in the recovery of bacteria resistant to cefoxitin in vitro after surgery. A single preoperative dose of cefoxitin was as effective in preventing major infection as were three perioperative doses, while providing other real and theoretic benefits.     

Cost-benefit analysis of cephradine and mezlocillin prophylaxis for abdominal and vaginal hysterectomy

Four hundred patients (300 abdominal and 100 vaginal hysterectomies) were randomized to receive a single, pre-operative intravenous injection of saline (placebo), 2 g cephradine or 5 g mezlocillin. The frequency of wound and pelvic infections was significantly reduced (P less than 0.05, chi 2- or Fisher's exact test) in the abdominal hysterectomy patients who received cephradine (16% vs 23% mezlocillin, 29% placebo) and in the vaginal hysterectomy patients who received cephradine or mezlocillin (0% mezlocillin, 6% cephradine vs 27% placebo). These results are similar to those of previous studies and suggest that prophylaxis is more effective for vaginal than for abdominal hysterectomy. However, a cost-benefit analysis supported the opposite conclusion. Cephradine prophylaxis for abdominal hysterectomy resulted in cost savings to the hospital and the community health services with measurable benefits to the patient. In contrast, cephradine or mezlocillin prophylaxis for vaginal hysterectomy resulted in increased costs to the hospital, no savings to community services and no significant benefit to the patient. We conclude that cost-benefit analysis provided valuable additional information to the conventional, statistical analysis of wound or pelvic infection rates.     

Clostridium difficile-associated diarrhea follows perioperative prophylaxis with cefoxitin

Clostridium difficile-associated diarrhea during prolonged therapy of obstetric and gynecologic infections is known to occur with use of all classes of antibiotics except vancomycin and the aminoglycosides. We present 11 cases of C. difficile-associated diarrhea which followed a short course of perioperative prophylaxis with cefoxitin during a 1-year period. Nine of the cases of C. difficile-associated diarrhea were among 162 women who received cefoxitin perioperative prophylaxis for cesarean section or hysterectomy, but none occurred in 85 women who received one of four other antibiotics for perioperative prophylaxis (p = 0.024, Fisher's exact test). The two other occurrences of C. difficile-associated diarrhea following perioperative prophylaxis with cefoxitin were in women who underwent exploratory laparotomy. We conclude that C. difficile-associated diarrhea is related to perioperative prophylaxis with cefoxitin.     

Recurrent acute leg cellulitis after hysterectomy with pelvic lymphadenectomy

Summary. Recurrent acute leg cellulitis known to occur in patients with impaired venous or lymphatic circulation was surveyed prospectively in 270 patients after radical hysterectomy with pelvic lymphadenectomy and in 66 patients after hysterectomy with pelvic lymphadenectomy from 1977 to 1985. Among them, six (2%) and three (4%) patients experienced a total of 17 episodes of acute leg cellulitis, respectively. Analysis showed that postoperative percutaneous radiation therapy of the pelvic area was a highly significant risk factor. Penicillin prophylaxis is recommended for patients experiencing recurrent attacks.