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.     

Postoperative infections and antibiotic prophylaxis for hysterectomy in Sweden: a study by the Swedish National Register for Gynecologic Surgery

AIM: The purpose of the study was to evaluate the current use of antibiotic prophylaxis, the rate of postoperative infections, and risk factors for postoperative infections in patients undergoing elective hysterectomy for non-malignant pathology. METHODS: The study was performed during the time period July 2000 to 1 January 1 2003, using data from the Swedish National Register for Gynecologic Surgery, covering 26 of 49 clinics and approximately 50% of the Swedish population. During this time period, 3267 women undergoing elective hysterectomy for non-malignant pathology (mainly dysfunctional bleeding and fibromas) and with complete data on the use of antibiotic prophylaxis and postoperative follow up were included. A postoperative infection was considered to have developed if patients or the physician reported an infection related to the surgical site, together with reported use of antibiotic treatment. RESULTS: Among the 3267 patients, 341 (10.4%) were considered to have developed a postoperative infection. In cases where antibiotic prophylaxis had not been given, total abdominal hysterectomies and vaginal hysterectomies were associated with the highest frequency for postoperative infections P < 0.05 and P < 0.01, respectively. Notably, also women undergoing subtotal hysterectomy reported significantly lower rates of postoperative infections if prophylactic antibiotics had been given, P < 0.05. Risk factors for postoperative infection were non-use of antibiotic prophylaxis, hospital, age less than 40 years, and BMI > 30 kg/m(2). CONCLUSIONS: The study results have indicated the need of prospective clinical trials on antibiotic prophylaxis for patients undergoing supravaginal abdominal hysterectomy. Also, a need to further evaluate the current prophylactic antibiotic protocols used for obese patients and younger women undergoing any kind of hysterectomy is warranted.     

Local prevention of infection with metronidazole before vaginal hysterectomy--comparative effect compared with systemic prevention?]

A prospective clinical trial was designed to examine the influence of a local intravaginal application of metronidazole on postoperative infectious morbidity in 114 women undergoing vaginal hysterectomy. On the evening before vaginal hysterectomy, 51 patients received a vaginal suppository of metronidazole (500 mg). These patients were compared with a group of 63 patients who were given a single-shot prophylaxis with 1,500 mg cefuroxime intravenously. With regard to febrile morbidity, urinary tract infection and pelvic infection there was no significant difference in the two treatment groups. There was no statistically significant difference in the postoperative duration of hospital stay and additional antibiotic therapy between the two groups either. We did not see serious infections in our examination. Our results suggest that a local single-dose application of metronidazole in vaginal hysterectomy might have the same efficacy on postoperative infectious morbidity than a systemic antibiotic prophylaxis and that it can reduce antibiotic costs.     

Effectiveness of infection prevention with latamoxef in vaginal hysterectomy. A prospective study

A prospective clinical trial was designed to examine the influence of a single-dose prophylaxis with 2 g Latamoxef on postoperative infectious morbidity in women undergoing vaginal hysterectomy. 91 vaginal hysterectomies with latamoxef prophylaxis were compared with a similar group of 99 patients without prophylaxis. Patients in the latamoxef group had significantly less postoperative infectious morbidity (23.1%) than those in the non prophylaxis group (45.1%). Prophylactic latamoxef reduced postoperative additional antibiotic therapy in the prophylaxis group significantly. The postoperative infectious morbidity (urinary tract infections, pelvic infections, febrile morbidity) was significantly reduced by a single-dose prophylaxis with 2 g Latamoxef.     

Effectiveness of perioperative preventive use of antibiotics with metronidazole or doxycycline in vaginal hysterectomy

To prove the effectiveness of perioperative antibiotics prophylaxis (PABP) in prevention of postoperative infections after vaginal hysterectomy the efficacy of rectale Metronidazole application (5 times 500 mg; n = 192) was compared with that of Doxycyclin (2 times 200 mg intravenously; n = 116). The infectious morbidity after both prophylactic antibiotic regimes was compared to that of an untreated group (n = 186). In spite of additionally colporrhapies the feverish standard morbidity without prophylaxis was 13.4%, after Metronidazole application 13.5% and after Doxycyclin 2.6% (p less than 0.05). Simultaneously the rate of necessary antibiotic treatment decreased significantly. Pelvic infections complicated 16.7% of vaginal hysterectomies having no prophylaxis, but only 4.3% after Doxycyclin medication (p less than 0.05). Postoperative urinary tract infections (UTI)--mostly asymptomatic bacteriuria--were not influenced by any PABP. Whereas UTI after bladder catheter duration shorter than two days occurred in 26.0% (without PABP), 29.9% (Metronidazole) respectively 18.2% (Doxycyclin; p greater than 0.05), the rates after a longer stay were 69.6%, 76.8% and 65.7%. It is concluded, that the febrile standard morbidity and pelvic infections were reduced as well as the rate of necessary antibiotics therapies by a prophylactic application of Doxycyclin, but not with Metronidazole. The incidence of postoperative UTI was not reduced by prophylaxis.     

Endometrial and vaginal cuff bacteria recovered at elective hysterectomy during a trial of antibiotic prophylaxis

The utility of culturing the cut edge of the vaginal cuff and endometrium of the uterine specimens of patients undergoing elective hysterectomy and receiving antibiotic prophylaxis has been critically examined. Subjects for this study represent a randomized subpopulation of patients participating in a larger controlled, prospective, double-blind study of antibiotic prophylaxis which has been conducted at Yale-New Haven Hospital during the past five years. On the basis of the organisms recovered, speculation is raised concerning the existence of an endometrial flora and the mechanisms of postoperative vaginal cuff infection in patients treated and not treated with antibiotic prophylaxis at the time of hysterectomy.     

Antibiotic prophylaxis against postpartum endometritis after vaginal delivery: a prospective randomized comparison between Amox-CA (Augmentin) and abstention

The most common adverse outcome associated with vaginal delivery is endometritis. It plays a significant role in postpartum morbidity and mortality. There is considerable evidence to support the idea that a single dose of antibiotic after vaginal delivery might decrease the incidence of postpartum endometritis. In this study the evaluation of the efficacy of antibiotic prophylaxis was based upon comparison of a group of patients given a single dose of Amox-CA (Augmentin^®) with a group of patients without treatment. The study was performed in the Department of Obstetrics and Gynecology of the A. Béclère Public Hospital, Clamart, France (Paris-Sud University). The patients who were the subject of the study had delivered vaginally during the period of 1 year, and were free of any clinical diagnosis of chorioamnionitis or other extragenital infection, had a maternal temperature of less than 38°C during labor and 1 h after delivery, and had no history of allergy to penicillins or cephalosporins. After application of exclusion criteria, 1373 patients were randomized and 1291 included 610 in Group I given Amox-CA and 681 in Group II without any antibiotic. A single dose of 1.2 g of Amox-CA was given by intravenous injection, 1 h after delivery, in Group I. Patients of Group II received no injection. Postpartum status was evaluated before the patient left hospital and 2 weeks later. The two groups were similar in terms of demographic and clinical parameters. Four patients developed endometritis in Group I (4/610, 0.66%). Sixteen patients in Group II developed endometritis (16/680, 2.38%) (P = 0.013; 95% confidence interval (CI), 0.36–3.08%). The conclusion is that a single dose of Amox-CA was effective and safe in the prevention of postpartum endometritis. The cost of prophylaxis is 70% lower than the cost of infection, according to the number of patients and the severity of endometritis. These data suggest that a single dose of antibiotic prophylaxis after vaginal delivery would result in a decreased endometritis rate, with substantial economic saving.     

Postoperative infections and antibiotic prophylaxis in radical hysterectomy. Review of the literature]

Postoperative infectious complications are a frequent cause of morbidity and mortality in the surgical patient. The septic events usually involve the urinary or respiratory tracts or occur at the operative site. The incidence depends on the surgeon's experience, the surgical procedure applied and the clinical status of the patient. Radical hysterectomy with pelvic lymphadenectomy is associated with a high risk of postoperative infections. Factors that influence the risk are prolonged preoperative hospitalization, duration of operation, younger age, obesity, estimated blood loss and lack of antibiotic prophylaxis. Appropriate administration of prophylactic antibiotics requires awareness of the following considerations: the choice of antibiotic agent, the dosage and the timing of administration for maximum benefit without adverse effects. In this review we evaluate the results of studies that use different regimens of antibiotic prophylaxis for prevention of infectious morbidity after radical hysterectomy.     

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%).     

Prophylaxis of minor febrile and major infectious morbidity following hysterectomy.

A retrospective analysis was conducted of 668 consecutive cases using T-tube suction drainage and/or prophylactic antibiotics as infection prophylaxis for hysterectomy. The data are analyzed for the incidence of minor febrile morbidity (temperature greater than 100.4 for 2 days) and for major infection (hospital stay more than 14 days, reoperation or readmission for the management of pelvic abscess or pelvic thrombophlebitis). The study also compares a minor febrile and major infection group with a noninfected group by measuring parameters of patient discomfort, medical staff effort, and financial costs. It is concluded that 1) minor febrile morbidity frequently follows abdominal (20--30%) and vaginal (30--50%) hysterectomy; 2) minor febrile morbidity has temporary but significant consequences in the form of increased patient discomfort, medical staff effort, and financial costs; 3) major infections are rare following abdominal hysterectomy (less than 0.5%) and uncommon following vaginal hysterectomy (1--4%); 4) suction drainage used alone, prophylactic antibiotics used alone, or a combination of suction drainage and antibiotic prophylaxis is each associated with a statistically significant reduction in the incidence of minor febrile morbidity following both abdominal and vaginal hysterectomy (P = less than 0.01); and 5) such infection prophylaxis may also reduce the incidence of major infection following vaginal hysterectomy.     

Piperacillin for prophylaxis in gynecological surgery

The effectiveness of perioperative Piperacillin for prevention of operative-site infection after gynaecological surgery was studied in a total of 100 patients. In an open randomized clinical trial of 52 women undergoing abdominal or vaginal hysterectomy Piperacillin was compared to the combination Gentamicin/Metronidazole. Piperacillin was well-tolerated. Surgical-site infection was diagnosed in the Piperacillin group in two patients and in the Gentamicin/Metronidazole group in one patient. The occurrence of postoperative febrile morbidity was also similar between the two group. In 48 patients undergoing complicated gynecological surgery of long duration, only Piperacillin was administered perioperatively. Thirty-five of these 48 women underwent oncological operations and the mean operative length was 3.3 h. One patient developed a transient rash after the administration of Piperacillin. No other adverse side-effects were observed. Nine of these 48 patients developed a surgical-site infection postoperatively, and this was found to be significantly more often than in the first group of 52 patients. It was concluded that Piperacillin seems to be a valuable alternative for perioperative prophylaxis in gynecological surgery. Its effectiveness in vaginal and abdominal hysterectomy is similar to the combination of Gentamicin/Metronidazole, but after complicated surgery of long duration a decreased effectiveness should be reckoned with.     

Low-dose carbenicillin prophylaxis for vaginal and abdominal hysterectomy.

A double-blind prospective study of 99 patients undergoing vaginal and abdominal hysterectomy was performed at North Carolina Baptist Hospital of the Bowman Gray School of Medicine at Wake Forest University. The study indicated that low-dose intravenous carbenicillin begun preoperatively and continued for 24 hours resulted in decreased febrile morbidity, postoperative infection rate, and shortened hospital stay in patients undergoing both vaginal and abdominal hysterectomy. The indications for operation, clinical characteristics of patients, and operative and postoperative management were similar for the control and study groups. For the vaginal hysterectomy group, febrile morbidity was reduced from 34.6% in the control group to 7.7% in the group receiving carbenicillin. For patients undergoing abdominal hysterectomy, febrile morbidity was reduced from 54.1% in the control group to 4.0% in the group receiving prophylactic carbenicillin. Similar reductions for the carbenicillin study group in fever index and average total hospital stay were also noted. Urinary tract infections were determined to be present more commonly in the group of patients with febrile morbidity receiving no prophylactic antibiotics. The incidence of pelvic infections were reduced in both carbenicillin-treated groups. This investigation suggests that low-dose carbenicillin prophylaxis is beneficial in reduction of morbidity following both vaginal and abdominal hysterectomy.     

Prophylactic antibiotics in gynecologic surgery.

A 2-year prospective double-blind study of prophylactic antibiotics in 317 patients undergoing elective total abdominal or vaginal hysterectomy was conducted. Patients randomly received placebo, penicillin, or cefazolin 30 minutes prior to surgery and at 6-hour intervals thereafter for 48 hours. Rigid criteria for postoperative morbidity were established. Vaginal hysterectomy patients given either penicillin or cefazolin prophylaxis had fewer postoperative infections (P less than 0.01) compared to those given placebo. A similar trend was noted among women undergoing abdominal hysterectomy; however, this trend was not statistically significant (P greater than 0.05). Despite continuous surveillance, no change in nosocomial flora or antibiotic sensitivity of bacterial isolates was noted. Adverse drug effects and antibiotic-resistant secondary infections were encountered with similar frequency in all treatment groups.     

The effect of a short-term course of antibiotic prophylaxis on patients undergoing total abdominal hysterectomy

A prospective double-blind study of antibiotic prophylaxis in 69 patients undergoing total abdominal hysterectomy was conducted. A short, 1-day course of cefazolin prophylaxis effectively decreased febrile morbidity, serious postoperative infections and hospital stay. Resistant infections or delayed infections were not encountered in this series of prophylactically treated patients. There was no difference between the active drug group and the placebo group in the frequency with which aerobic Gram-negative rods and the incidence of cephalosporin-resistant organisms cultured postoperatively.     

Comparative study of short-term antimicrobial chemoprophylaxis in gynecologic surgery: cefotetan versus cefazolin

The results obtained in 80 patients hospitalized at the University of Obstetrics and Gynecology Clinic in Perugia for abdominal and vaginal hysterectomy are reported and evaluated in a prospective and randomized study of perioperative antibacterial prophylaxis. In the 75 patients available to study a single intravenous dose of 2 g cefotetan was compared with a triple dose of 1 g intravenous cephazolin. A reduction in the incidence of post-operative infections both in abdominal hysterectomy from 24% (cephazolin group) to 11.53% (cefotetan group) and in vaginal hysterectomy from 40% (cephazolin group) to 71.4% (cefotetan group) was noted. These results show that a single intravenous dose of 2 g cefotetan can be considered a valid therapeutic support for antibacterial prophylaxis. In addition the absence of alterations in the parameters considered (haematological, biochemical and urinary) points to the safety, effectiveness and non-toxicity of the drug.     

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.     

Ceftriaxone and cefazolin prophylaxis for hysterectomy

Two hundred and twenty-five women scheduled for elective hysterectomy were entered into a prospective, comparative, randomized, double-blind clinical trial of antibiotic prophylaxis; 117 had vaginal hysterectomy and 108 had abdominal hysterectomy. They were given a 1 gram preoperative dose of ceftriaxone, an investigational cephalosporin or three 1 gram parenteral doses of cefazolin over a 16 hour period. Antibiotic concentrations were measured in serum and vagina, myometrium, fallopian tube or ovary and mean ceftriaxone concentrations were consistently higher than those of cefazolin. Both regimens were safe, well tolerated and equally effective at preventing major postoperative infection. Diabetes increased the risk for infection regardless of regimen and surgical approach (p = 0.009) and specific risk factors were identified for women undergoing vaginal hysterectomy. The incidence of infection was 1.7 per cent after vaginal hysterectomy, significantly lower than the 7.4 per cent observed after abdominal hysterectomy (p = 0.039). Several of the clinical and surgical variables were identified that could explain this difference.     

Prospective randomized comparison of single-dose versus 1-day cefazolin for prophylaxis in gynecologic surgery

BACKGROUND: The purpose of this prospective, randomized study was to compare the efficacy of single-dose versus 1-day cefazolin prophylaxis for the prevention of postoperative gynecologic infections. METHODS: From June 2001 to January 2003, 548 patients were randomized to receive either single-dose (1 g of cefazolin intravenously before surgery, 273 patients) or 1-day cefazolin (1 g intravenously before surgery and three more doses every 6 hr after surgery, 275 patients) prophylaxis. RESULTS: A total of 531 (267 patients in the single-dose group and 264 in the 1-day group) completed the study. Only one of 267 (0.37%) patients in the single-dose group developed a trocar wound infection and one of 264 (0.37%) patients in the 1-day group developed a vaginal cuff infection. Had a single dose of prophylactic antibiotics been administered to all patients, the antibiotic cost would have been reduced by 75-80%. CONCLUSIONS: The use of single-dose preoperative cefazolin prophylaxis was as effective as four doses of cefazolin for preventing serious infectious morbidity among our patients. Shortening the duration of antibiotics prophylaxis also reduced medical costs and microorganism resistance.     

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.