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.     

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.     

Evaluation of the improvement of cephems on the prophylaxis of pelvic infection after radical hysterectomy.

Antibiotics, especially cephems, have been improved remarkably in the last 20 years. In order to evaluate the improvement of antibiotics used for the prophylaxis of infections after radical hysterectomy, two groups of patients (group A, 1978-1979, n = 54; group B, 1985-1987, n = 55) were examined in regard to bacteriological and clinical effects. In spite of the improvement of antibiotics, the positive rate of bacteriological analysis had increased from 44.4 to 76.4%. Obvious decrease of gram-negative bacilli and increase of gram-positive cocci (GPC), e.g. Enterococcus, were observed. In contrast, fever index and febrile morbidity of group B decreased significantly more than those of group A. These results indicate that the improvement of antibiotics has brought more effective prophylaxis in the postoperative infection in spite of the high positive rate of GPC.     

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.     

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.     

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%).     

Infection after radical abdominal hysterectomy and pelvic lymphadenectomy: prevention of infection with a two-dose peri-operative antibiotic prophylaxis

Surgical site-related infections occurred in 21% of 87 consecutive patients undergoing radical hysterectomy with pelvic lymphadenectomy (RHPL) without planned peri-operative prophylaxis. A prospective, randomized double-blind, placebo-controlled study was conducted in 68 consecutive RHPL patients. In the 32 available patients with two-dose cefuroxime and metronidazole prophylaxis no surgical site-related infections developed as opposed to a rate of 14% in the 28 patients in the placebo group ( P < 0.05). In a prospective, randomized double-blind study two two-dose antibiotic prophylactic regimens were compared in 105 consecutive patients. Surgical site-related infections developed in one (2%) patient in the cefuroxime plus metronidazole group, and in six (12%) patients in the moxalactam group. This difference did not achieve statistical significance. The mean length of the postoperative hospital stay of the patients with scheduled surgical prophylaxis was significantly shorter ( P < 0.01) than that of the patients operated on without surgical prophylaxis. A two-dose antibiotic regimen is recommended, because levels of antibiotics assayed in samples collected during the course of the operation indicated a rapid clearance of the antibiotics from the operative site, most likely due to the high volume of peri-operative blood loss.     

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.     

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.     

Pharmacodynamics of antibiotic penetration of tissue and surgical prophylaxis

The morbidity and mortality of infection in surgical treatment remains substantial. Many principles for the prevention and treatment of surgical infections have been established. Proper selection and preparation of patients and meticulous operative techniques are of primary importance in the prevention of surgical infections. Surgical antibiotic prophylaxis is also beneficial when an adequate tissue level is present before and throughout the duration of the procedure. The level attained in the tissues is dependent on many factors that affect the pharmacokinetics of antibiotic distribution and excretion. One factor is protein binding, which alters the fraction of free drug available for diffusion into tissues. However, the singular importance of this effect on the concentration of antibiotics in tissues is minimal. In surgical prophylaxis, the maintenance of antibiotic tissue activity at the sites of potential infection for the duration of the operation is crucial. Failure to provide persistent antibiotic tissue activity throughout the entire procedure results in an increased number of surgical infections. The pharmacokinetics of distribution and the half-life of antibiotics in the serum are directly related to the duration of activity of antibiotic in the tissue. Antibiotics with longer half-lives maintain levels in the tissues for longer periods than do antibiotics with shorter half-lives. The maintenance of the levels of a given antibiotic is similar for all tissues. The application of the pharmacokinetic properties of antibiotics to surgical prophylaxis can provide the surgeon with certainty that adequate coverage and protection with antibiotics are achieved before and throughout the operation.     

Role of antibiotic prophylaxis in retropubic surgery for stress urinary incontinence

The effectiveness of prophylactic antibiotics was studied prospectively in 26 women undergoing retropubic urethropexy for genuine stress incontinence. Each of the 14 patients in the antibiotic prophylaxis group received three 1-g doses of intravenous cefazolin administered before, during, and 6-8 hours after surgery. Twelve women served as a control group and did not receive prophylactic antibiotics. Postoperative febrile morbidity and hospital stay were significantly less (P less than .01 and P less than .05, respectively) in patients who received prophylactic antibiotics.     

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.     

Effectiveness of perioperative preventive use of antibiotics with ampicillin/gentamycin or cefotiam in abdominal cesarean section

To prove the effectiveness of perioperative antibiotics prophylaxis (pabp) in prevention of postoperative infections after caesarean section the efficiency of a Ampicillin/Gentamycin combination was compared with that of Cefotiam (Halospor). The infectious morbidity after both prophylactic antibiotic regimes was compared to that of an untreated sectioned group. The feverish standard morbidity (fsm) of all caesarean sections (between 1. 7. 1986-30. 6. 1988; n = 354) decreased by selective pabp from 25.3% to 16.7%. Compared with untreated patients (no infectional risk; fsm: 22.4%) the infectional morbidity after caesarean section was reduced by Ampicillin/Gentamycin (fsm: 10.0%; p less than 0.05) and also by Halospor (fsm: 13.7; p greater than 0.05). Uterine (14.5%) and urinary tract infections (6.6%) were the most frequent causes of fever during puerperium. After pabp the frequency of this causes decreased evidently. The rate of postoperative antibiotics therapies went down from 26.3% without pabp to 13.3% (p less than 0.05) with Ampicillin/Gentamycin respectively 13.7% (p less than 0.05) with Cefotiam. It is concluded, that the feverish standard morbidity was reduced by a selective papb both with Ampicillin/Gentamycin and Halospor. As a consequence of our results we are performing the pabp with a single dose of 2 g Halospor combined with 0.5 g Metronidazol in all sections generally.     

A randomised controlled trial of antibiotic prophylaxis for vesico-vaginal fistula repair

Objective To test the hypothesis that intravenous antibiotics given intra-operatively reduce the failure rate of vesico-vaginal fistula repair.
Design A single blind, randomised controlled trial.
Setting A district hospital in Benin, West Africa.
Population Seventy-nine women undergoing repair of an obstetric vesico-vaginal fistula by a single surgeon at Hopital Evangelique; two women had repeat operations.
Methods Participants in the treatment group (  n = 41  ) received ampicillin 500 mg intra-operatively. Controls (  n = 40  ) received no prophylactic antibiotics.
Main outcome measures Failure of fistula closure and objective incontinence (a positive pad test) at hospital discharge. Secondary outcomes included febrile morbidity, other antibiotic use and urinary infection.
Results Antibiotic prophylaxis did not reduce the odds of failed repair (OR 2.1 95% CI 0.75–6.1) or of objective incontinence (OR 1.9; 95% CI 0.72–5.1). The women in the antibiotic prophylaxis group received less post-operative antibiotics and had less urinary infections at day 10.
Conclusions Prophylactic antibiotics should not be used in vesico-vaginal fistulae repair in the developing world outside randomised controlled trials.     

Prevention of postoperative complications following vaginal hysterectomy

In a prospective study on infectious morbidity after vaginal hysterectomy we examined the clinical symptoms of an infection and partly also the microbial conditions of the vaginal wound. With a group of 49 patients without antibiotic prophylaxis we tried to find out if the type of vaginal occlusion might have any influence on the microbial situation and the healing process. The results of this first group were compared to those of a second group consisting of 31 patients, who had received antibiotic prophylaxis before the operation with a cephalosporin. Though it was not possible to make any microbial analyses in the second group, the clinical evaluation showed distinctly that antibiotic prophylaxis is an important contribution to the prevention of infections after vaginal hysterectomy. The careful consideration of septic-surgical precautions, however, and this was proved by the first part of the study, contributes as well to the prevention of infections.     

A randomized prospective trial comparing the value of intravenous and preincisional cefamandole in reducing postoperative sepsis after operations upon the gastrointestinal tract

A prospective randomized trial comparing prophylaxis with a single dose of cefamandole given intravenously and preincisionally with no antibiotics in patients who underwent elective and emergency operations upon the gastrointestinal tract has shown a significant reduction in the frequency of wound infections in patients receiving preincisional antibiotics over both control and intravenous groups. Fewer postoperative infections of the chest occurred in patients receiving antibiotics by either route, with hospital stay also being significantly reduced for patients who received prophylactic antibiotics before emergency operations. Preincisional cefamandole is effective in reducing postoperative sepsis after operations upon the gastrointestinal tract.     

Prospective randomized controlled study of prophylaxis with cefamandole in high risk patients undergoing operations upon the biliary tract

In this study, 52 high risk patients who underwent operations upon the biliary tract were assigned to receive either antibiotic prophylaxis or no treatment with antibiotics. Twenty-seven patients were given 2 grams of cefamandole intramuscularly 30 minutes before operation and 2 grams every eight hours for two days postoperatively. The remaining patients were in the control group and did not receive antibiotics. Surgical wounds were inspected daily by a surgeon while the patients were in the hospital and a follow-up revision was done four weeks after discharge from the hospital. Samples of exudate or pus were taken when the wound appeared infected and cultures of aerobic and anaerobic organism done. Chi-square affinity test with Yate's correction was used for statistical results; only p values more than or equal to 0.5 were considered significant. Seven patients (28 per cent) in the control group had complications develop postoperatively; seven surgical wound infections, one of which included a subphrenic abscess. Postoperatively, there were no septic complications in the group who received cefamandole as a prophylaxis. The incidence of infection was higher for females than males. The organisms most frequently isolated were Escherichia coli and Klebsiella; only in one instance was Clostridum sporogenes found. Polymicrobial infections accounted for 42.8 per cent of the infections. No incidences were reported with the use of cefamandole in those patients who were treated prophylactically. In view of these results, we believe that cefamandole is an ideal antibiotic to be used in the prophylactic treatment of infections of high risk patients who undergo operations upon the biliary tract.     

Short-term prophylactic antibiotic for elective abdominal hysterectomy: how short?

A prospective double-blind study was conducted in order to evaluate the effect of antibiotic prophylaxis on patients undergoing elective abdominal hysterectomy. In the first stage of the study, 116 patients received, on call to the operating room and subsequently 8 and 16 h post-operatively, cefazolin sodium or placebo. In the second stage of the study, 90 patients received the same antibiotics, but treatment was extended to 6 doses, 8 h apart. Of the 53 women who received placebo, 27 (50.9%) became morbid, while only 15 of the 63 (23.8%) who received 24 h prophylaxis were classified as morbid (p less than 0.005). By extending the prophylactic treatment to 48 h further reduction of the morbidity was achieved. Of the 90 patients only 11 (12.2%) became morbid (P less than 0.005). When morbidity rates were compared between different ethnic groups, over-weight and normal weight patients, pre- and post-menopausal women, it was not possible to define a group which is at a higher risk for post-operative morbidity. It was thus concluded that prophylactic antibiotics should be administered routinely to all patients undergoing abdominal hysterectomy, preferably for 48 h.     

Preoperative hot conization of the cervix: a possible method to reduce postoperative febrile morbidity following vaginal hysterectomy.

Laboratory results indicate that the endocervix may be a source of bacterial contamination when vaginal hysterectomy is performed. In a series of 160 consecutive vaginal hysterectomies in premenopausal women, hot conization of the cervix was performed prior to the scrub with an iodophore. No preoperative antibiotics were used in this series. The postoperative febrile morbidity rate was 4.3 per cent and the average stay was 4.5 days. These results are compared with those of three other groups: (1) patients who received a three-dose parenteral prophylactic antibiotic course with the first dose two hours prior to surgery had a febrile morbidity rate of 8.6 per cent. (2) In patients who had prophylactic antibiotics for five days with the first dose given intraoperatively, the febrile morbidity rate was 10.1 per cent. (3) The febrile morbidity rate in the group with no antibiotic prophylaxis or hot conization was 49.1 per cent. Laboratory and clinical data suggest that preoperative conization may be effective in the reduction of postoperative febrile morbidity.