Use of single agent Cefotetan for Gustilo-Anderson type III open fracture prophylaxis.

INTRODUCTION: The prophylactic intravenous antibiotic regimen for Gustilo-Anderson Type III open fractures traditionally consists of cefazolin with an aminoglycoside plus penicillin for gross contamination. Cefotetan, a second-generation cephalosporin, offers a wide spectrum of activity against both aerobes and anaerobes as well as against Gram-positive and Gram-negative bacteria. Cefotetan has not been previously established within orthopedic surgery as a prophylactic intravenous agent. PATIENTS AND METHODS: Cefotetan monotherapeutic prophylaxis versus any other antibiotic regimen (standard/literature-supported and otherwise) was studied for patient encounters between September 2010 and December 2019 within a single Level 1 regional trauma center. Patient comorbidities, preoperative fracture characteristics, and in-hospital/operative metrics (including length of stay [LOS], number of antibiotic doses, and antibiotic costs [US$]) were included for analysis. Postoperative outcomes up to 1 year included rates of surgical site infection (SSI), deep infection necessitating return to the operating room (OR), non-union, prescribed outpatient antibiotics, hospital readmissions, and related returns to the emergency department (ED). Sensitivity analyses were also conducted to include standard/literature-supported antibiotic regimens as a nested random factor within the non-cefotetan cohort. RESULTS: The nested variable accounting for standard/literature-supported antibiotic regimens had no significant effect in any model for any outcome (for each, P ≥ 0.302). Thus, 1-year data for 138 Type III open fractures were included, accounting for only the binary effect of cefotetan (n = 42) versus non-cefotetan cohorts. The cohorts did not differ significantly at baseline. The cefotetan cohort received fewer in-house dose/day antibiotics (P < 0.001), was less likely to receive outpatient antibiotics in the following year (P = 0.023), had decreased return to the OR (35.7% versus 54.2%, P = 0.045), and demonstrated non-union rates of 16.7% versus 28.1% (P = 0.151). When adjusted for length of stay (LOS), the dose/day total costs for antibiotics were $8.71/day more expensive for the cefotetan cohort (P = 0.002). Type III open fractures incurred overall rates of SSI reaching 16.7% in the cefotetan cohort and 14.7% for non-cefotetan (P = 0.773). Deep infections necessitating return to the OR were 9.5% and 11.6%, respectively (P = 0.719). CONCLUSION: Cefotetan alone may provide superior antibiotic stewardship with similar infectious sequalae compared to more traditional antibiotic prophylaxis regimens for Gustilo-Anderson Type III open long bone fractures. LEVEL OF EVIDENCE: Level III Retrospective Cohort Study.

Antibiotic prophylaxis for operative vaginal delivery.

BACKGROUND: Vacuum and forceps assisted vaginal deliveries are reported to increase the incidence of postpartum infections and maternal readmission to hospital compared to spontaneous vaginal delivery. Prophylactic antibiotics may be prescribed to prevent these infections. However, the benefit of antibiotic prophylaxis for operative vaginal deliveries is still unclear. This is an update of a review last published in 2017. OBJECTIVES: To assess the effectiveness and safety of antibiotic prophylaxis in reducing infectious puerperal morbidities in women undergoing operative vaginal deliveries including vacuum or forceps delivery, or both. SEARCH METHODS: For this update, we searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (5 July 2019), and reference lists of retrieved studies. SELECTION CRITERIA: All randomised controlled trials comparing any prophylactic antibiotic regimens with placebo or no treatment in women undergoing vacuum or forceps deliveries were eligible. Participants were all pregnant women without evidence of infections or other indications for antibiotics of any gestational age. Interventions were any antibiotic prophylaxis (any dosage regimen, any route of administration or at any time during delivery or the puerperium). DATA COLLECTION AND ANALYSIS: Two review authors assessed trial eligibility and risk of bias. Two review authors extracted the data independently using prepared data extraction forms. Any discrepancies were resolved by discussion and a consensus reached through discussion with all review authors. We assessed methodological quality of the two included studies using the GRADE approach. MAIN RESULTS: Two studies, involving 3813 women undergoing either vacuum or forceps deliveries, were included. One study involving 393 women compared the antibiotic intravenous cefotetan after cord clamping compared with no treatment. The other study involving 3420 women compared a single dose of intravenous amoxicillin and clavulanic acid with placebo using 20 mL of intravenous sterile 0.9% saline. The evidence suggests that prophylactic antibiotics reduce superficial perineal wound infection (risk ratio (RR) 0.53, 95% confidence interval (CI) 0.40 to 0.69; women = 3420; 1 study; high-certainty evidence), deep perineal wound infection (RR 0.46, 95% CI 0.31 to 0.69; women = 3420; 1 study; high-certainty evidence) and probably reduce wound breakdown (RR 0.52, 95% CI 0.43 to 0.63; women = 2593; 1 study; moderate-certainty evidence). We are unclear about the effect on organ or space perineal wound infection (RR 0.11, 95% CI 0.01 to 2.05; women = 3420; 1 study) and endometritis (average RR 0.32, 95% CI 0.04 to 2.64; 15/1907 versus 30/1906; women = 3813; 2 studies) based on low-certainty evidence with wide CIs that include no effect. Prophylactic antibiotics probably lower serious infectious complications (RR 0.44, 95% CI 0.22 to 0.89; women = 3420; 1 study; high-certainty evidence). They also have an important effect on reduction of confirmed or suspected maternal infection. The two included studies did not report on fever or urinary tract infection. It is unclear, based on low-certainty evidence, whether prophylactic antibiotics have any impact on maternal adverse reactions (RR 2.00, 95% CI 0.18 to 22.05; women = 2593; 1 study) and maternal length of stay (MD 0.09 days, 95% CI -0.23 to 0.41; women = 393; 1 study) as the CIs were wide and included no effect. Prophylactic antibiotics slightly improve perineal pain and health consequences of perineal pain and probably reduce costs. Prophylactic antibiotics did not have an important effect on dyspareunia (difficult or painful sexual intercourse) or breastfeeding at six weeks. Antibiotic prophylaxis may slightly improve maternal hospital re-admission and maternal health-related quality of life. Neonatal adverse reactions were not reported in any included trials. AUTHORS' CONCLUSIONS: Prophylactic intravenous antibiotics are effective in reducing infectious puerperal morbidities in terms of superficial and deep perineal wound infection or serious infectious complications in women undergoing operative vaginal deliveries without clinical indications for antibiotic administration after delivery. Prophylactic antibiotics slightly improve perineal pain and health consequences of perineal pain, probably reduce the costs, and may slightly reduce the maternal hospital re-admission and health-related quality of life. However, the effect on reduction of endometritis, organ or space perineal wound infection, maternal adverse reactions and maternal length of stay is unclear due to low-certainty evidence. As the evidence was mainly derived from a single multi-centre study conducted in a high-income setting, future well-designed randomised trials in other settings, particularly in low- and middle-income settings, are required to confirm the effect of antibiotic prophylaxis for operative vaginal delivery.

Use and Effectiveness of Peri-Operative Cefotetan versus Cefazolin Plus Metronidazole for Prevention of Surgical Site Infection in Abdominal Surgery Patients.

BACKGROUND: Current practice guidelines for antimicrobial prophylaxis in surgery recommend a cephamycin or cefazolin plus metronidazole for various abdominal surgeries. In February 2016, cephamycin drug shortages resulted in a change in The Johns Hopkins Hospital's (JHH) recommendation for peri-operative antibiotic prophylaxis in abdominal surgeries from cefotetan to cefazolin plus metronidazole. The primary objective of this study was to quantify the percentage of abdominal surgeries adherent to JHH peri-operative antibiotic prophylaxis guidelines. A sub-group analysis investigated whether prophylaxis with cefazolin plus metronidazole was associated with a lower rate of surgical site infections (SSIs) versus cefotetan. PATIENTS AND METHODS: This retrospective cohort study included adult inpatients who underwent an abdominal surgery at JHH in September 2015 (Study Period I: cefotetan) or February to March 2016 (Study Period II: cefazolin plus metronidazole). RESULTS: Two hundred abdominal surgery cases were included in the primary analysis. A subset of 156 surgical cases were included in the sub-group analysis. The overall adherence rate to JHH guidelines was 75% in Study Period I versus 17% in Study Period II (p < 0.001). The largest difference in adherence was attributed to pre-operative administration time (87% vs. 23%, p < 0.001), primarily because of the longer infusion time required for metronidazole. Surgical site infections occurred in 14% (12/83) of surgeries with cefotetan versus 8.2% (6/73) with cefazolin plus metronidazole for prophylaxis (p = 0.19). CONCLUSIONS: Adherence to an institution-specific peri-operative antibiotic prophylaxis guideline for abdominal surgeries was limited primarily by the longer infusion time required for pre-operative metronidazole. A higher percentage of SSIs occurred among abdominal surgeries with cefotetan versus cefazolin plus metronidazole for prophylaxis.

Antibiotic regimens for management of intra-amniotic infection.

BACKGROUND: Chorioamnionitis is a common infection that affects both mother and infant. Infant complications associated with chorioamnionitis include early neonatal sepsis, pneumonia, and meningitis. Chorioamnionitis can also result in maternal morbidity such as pelvic infection and septic shock.Clinical chorioamnionitis is estimated to occur in 1% to 2% of term births and in 5% to 10% of preterm births; histologic chorioamnionitis is found in nearly 20% of term births and in 50% of preterm births. Women with chorioamnionitis have a two to three times higher risk for cesarean delivery and a three to four times greater risk for endomyometritis, wound infection, pelvic abscess, bacteremia, and postpartum hemorrhage. OBJECTIVES: To assess the effects of administering antibiotic regimens for intra-amniotic infection on maternal and perinatal morbidity and mortality and on infection-related complications. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (1 October 2014), CENTRAL, MEDLINE, Embase, LILACS, and the WHO ICTRP (September 2014). We also searched reference lists of retrieved studies and contacted experts in the field. SELECTION CRITERIA: Randomized controlled trials (RCTs) that included women who experienced intra-amniotic infection. Trials were included if they compared antibiotic treatment with placebo or no treatment (if applicable), treatment with different antibiotic regimens, or timing of antibiotic therapy (intrapartum and/or postpartum). Therefore, this review assesses trials evaluating intrapartum antibiotics, intrapartum and postpartum antibiotic regimens, and postpartum antibiotics. Diagnosis of intra-amniotic infection was based on standard criteria (clinical/test), and no limit was placed on gestational age. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion and trial quality. Two review authors independently extracted data and checked them for accuracy. We assessed the quality of the evidence using the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach and included a 'Summary of findings' table. MAIN RESULTS: Our prespecified primary outcomes were maternal and neonatal mortality, maternal and neonatal severe infection, and duration of maternal and neonatal hospital stay.We included 11 studies (involving 1296 women) and assessed them as having low to moderate risk of bias - mainly because allocation concealment methods were not adequately reported, most studies were open, and outcome reporting was incomplete. The quality of the evidence was low to very low for most outcomes, as per the GRADE approach. The following antibiotics were assessed in the included trials: ampicillin, ampicillin/sulbactam, gentamicin, clindamycin, and cefotetan. During labor: meta-analysis of two studies found no clear differences in rates of neonatal sepsis (163 neonates; risk ratio (RR) 1.07, 95% confidence interval (CI) 0.40 to 2.86; I² = 9%; low quality of evidence), treatment failure (endometritis) (163 participants; RR 0.86, 95% CI 0.27 to 2.70; I² = 0%; low quality of evidence), and postpartum hemorrhage (RR 1.39, 95% CI 0.76 to 2.56; I² = 0%; low quality of evidence) when two different dosages/regimens of gentamicin were assessed. No clear differences between groups were found for any reported maternal or neonatal outcomes. The review did not identify data for a comparison of antibiotics versus no treatment/placebo. Postpartum: meta-analysis of two studies that evaluated use of antibiotics versus placebo after vaginal delivery showed no significant differences between groups in rates of treatment failure or postpartum endometritis. No significant differences were found in rates of neonatal death and postpartum endometritis when use of antibiotics was compared with no treatment. Four trials assessing two different dosages/regimens of gentamicin or dual-agent therapy versus triple-agent therapy, or comparing antibiotics, found no significant differences in most reported neonatal or maternal outcomes; the duration of hospital stay showed a difference in favor of the group of women who received short-duration antibiotics (one study, 292 women; mean difference (MD) -0.90 days, 95% CI -1.64 to -0.16; moderate quality of evidence). Intrapartum versus postpartum: one small study (45 women) evaluating use of ampicillin/gentamicin during intrapartum versus immediate postpartum treatment found significant differences favoring the intrapartum group in the mean number of days of maternal postpartum hospital stay (one trial, 45 women; MD -1.00 days, 95% CI -1.94 to - 0.06; very low quality of evidence) and the mean number of neonatal hospital stay days (one trial, 45 neonates; MD -1.90 days, 95% CI -3.91 to -0.49; very low quality of evidence). Although no significant differences were found in the rate of maternal bacteremia or early neonatal sepsis, for the outcome of neonatal pneumonia or sepsis we observed a significant difference favoring intrapartum treatment (one trial, 45 neonates; RR 0.06, 95% CI 0.00 to 0.95; very low quality of evidence). AUTHORS' CONCLUSIONS: This review included 11 studies (having low to moderate risk of bias). The quality of the evidence was low to very low for most outcomes, as per the GRADE approach. Only one outcome (duration of hospital stay) was considered to provide moderate quality of evidence when antibiotics (short duration) were compared with antibiotics (long duration) during postpartum management of intra-amniotic infection. Our main reasons for downgrading the quality of evidence were limitations in study design or execution (risk of bias), imprecision, and inconsistency of results.Currently, limited evidence is available to reveal the most appropriate antimicrobial regimen for the treatment of patients with intra-amniotic infection; whether antibiotics should be continued during the postpartum period; and which antibiotic regimen or what treatment duration should be used. Also, no evidence was found on adverse effects of the intervention (not reported in any of the included studies). One small RCT showed that use of antibiotics during the intrapartum period is superior to their use during the postpartum period in reducing the number of days of maternal and neonatal hospital stay.

Antibiotic prophylaxis for third- and fourth-degree perineal tear during vaginal birth.

BACKGROUND: One to eight per cent of women suffer third-degree perineal tear (anal sphincter injury) and fourth-degree perineal tear (rectal mucosa injury) during vaginal birth, and these tears are more common after forceps delivery (28%) and midline episiotomies. Third- and fourth-degree tears can become contaminated with bacteria from the rectum and this significantly increases in the chance of perineal wound infection. Prophylactic antibiotics might have a role in preventing this infection. OBJECTIVES: To assess the effectiveness of antibiotic prophylaxis for reducing maternal morbidity and side effects in third- and fourth-degree perineal tear during vaginal birth. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 August 2014) and the reference lists of retrieved articles. SELECTION CRITERIA: Randomised controlled trials comparing outcomes of prophylactic antibiotics versus placebo or no antibiotics in third- and fourth-degree perineal tear during vaginal birth. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed the trial reports for inclusion and risk of bias, extracted data and checked them for accuracy. MAIN RESULTS: We identified and included one trial (147 women from a pre-planned sample size of 310 women) that compared the effect of prophylactic antibiotic (single-dose, second-generation cephalosporin - cefotetan or cefoxitin, 1 g intravenously) on postpartum perineal wound complications in third- or fourth-degree perineal tears compared with placebo. Perineal wound complications (wound disruption and purulent discharge) at the two-week postpartum check up were 8.20% and 24.10% in the treatment and the control groups respectively (risk ratio (RR) 0.34, 95% confidence interval (CI) 0.12 to 0.96). However, the high failed-appointment rate may limit the generalisability of the results. The overall risk of bias was low except for incomplete outcome data. The quality of the evidence using GRADE was moderate for infection rate at two weeks' postpartum, and low for infection rate at six weeks' postpartum. AUTHORS' CONCLUSIONS: Although the data suggest that prophylactic antibiotics help to prevent perineal wound complications following third- or fourth-degree perineal tear, loss to follow-up was very high. The results should be interpreted with caution as they are based on one small trial.

Cefotetan versus conventional triple antibiotic prophylaxis in elective colorectal cancer surgery.

This study examined infectious outcomes in elective colorectal cancer surgery between cefotetan alone or conventional triple antibiotics. From January to December 2007, 461 consecutive primary colorectal cancer patients underwent elective surgery. Group A contained 225 patients who received conventional triple antibiotics (cephalosporin, aminoglycoside and metronidazole) for prophylaxis, and group B contained 236 patients who received cefotetan alone for prophylaxis. Treatment failure was defined as the presence of postoperative infection including surgical-site infection (SSI), anastomotic leakage, and pneumonia or urinary tract infection. The two groups were similar in terms of demographics, American Society of Anesthesiologists (ASA) score, tumour location, stage, surgical approach (conventional open vs. laparoscopy-assisted), and type of operation. The treatment failure rates were 3.1% in Group A and 3.4% in Group B (absolute difference, -0.3%; 95% confidence interval [CI], 0.39 to 3.07, P=0.866), with SSI being the most common reason for failure in both groups (2.7% in Group A and 3.0% in Group B [absolute difference, -0.3%; 95% CI, 0.37 to 3.37, P=0.846]). Cefotetan alone is as effective as triple antibiotics for prophylaxis in primary colorectal cancer patients undergoing elective surgery.

Cefotetan versus Conventional Triple Antibiotic Prophylaxis in Elective Colorectal Cancer Surgery

This study examined infectious outcomes in elective colorectal cancer surgery between cefotetan alone or conventional triple antibiotics. From January to December 2007, 461 consecutive primary colorectal cancer patients underwent elective surgery. Group A contained 225 patients who received conventional triple antibiotics (cephalosporin, aminoglycoside and metronidazole) for prophylaxis, and group B contained 236 patients who received cefotetan alone for prophylaxis. Treatment failure was defined as the presence of postoperative infection including surgical-site infection (SSI), anastomotic leakage, and pneumonia or urinary tract infection. The two groups were similar in terms of demographics, American Society of Anesthesiologists (ASA) score, tumour location, stage, surgical approach (conventional open vs. laparoscopy-assisted), and type of operation. The treatment failure rates were 3.1% in Group A and 3.4% in Group B (absolute difference, -0.3%; 95% confidence interval [CI], 0.39 to 3.07, P=0.866), with SSI being the most common reason for failure in both groups (2.7% in Group A and 3.0% in Group B [absolute difference, -0.3%; 95% CI, 0.37 to 3.37, P=0.846]). Cefotetan alone is as effective as triple antibiotics for prophylaxis in primary colorectal cancer patients undergoing elective surgery.

Impact of surgical site infections on length of stay and costs in selected colorectal procedures.

BACKGROUND: Length of stay (LOS) and inpatient costs for open-abdomen colorectal procedures have not been examined recently. The aim of this study was to determine LOS and costs for several colorectal procedures in the context of factors potentially associated with surgical site infection (SSI). METHODS: We used a large U.S. hospital database to identify the variables associated with longer LOS and higher costs for colorectal procedures from January 1, 2005, through June 30, 2006. The study population consisted of all patients >18 years, identified via International Classification of Disease, Ninth Revision, procedural codes for elective colorectal surgery. Patient demographics, surgical procedure, and a modified Study of the Efficacy of Nosocomial Infection Control (SENIC) infection risk score were examined using logistic regression as predictors of LOS >or=1 week and cost >or=$15,000. Patients given cefotetan as surgical prophylaxis were compared with patients given cefazolin/metronidazole. Superficial and deep SSIs were considered; intra-abdominal infection was not. RESULTS: The 25,825 patients were of average age 63 years, with 53% being female and 75% being Caucasian. The overall infection rate was 3.7%. The mean LOS was 7.25 days, and the mean +/- standard deviation total cost per patient $13,746 +/- $13,330. Rates of infection, LOS, and mean hospital costs were all greater for patients with a high SENIC score and increasing disease acuity. Values for these outcome variables were highest for procedures involving stoma formation, followed by operations on the small bowel and large bowel. Variables independently predictive of longer LOS were SSI (odds ratio [OR] 11.74; 95% confidence interval [CI] 9.67, 14.26), age >or=65 years (OR 1.90; 95% CI 1.81, 2.01), and high SENIC score (OR 1.79; 95% CI 1.67, 1.92), whereas Caucasian race (OR 0.86; 95% CI 0.81, 0.91) was predictive of a shorter LOS. Cefazolin/metronidazole was not predictive of a shorter LOS compared with cefotetan (OR 1.06; 95% CI 0.96, 1.17) but was associated with significantly more hospitalizations with costs >or=$15,000 (OR 1.39; 95% CI 1.23, 1.56). CONCLUSIONS: Length of stay and cost rise proportionally with SENIC score, disease acuity, and patient characteristics such as age. Surgical site infections are significantly and independently associated with LOS and cost and contribute to inpatient morbidity and expense. Cefotetan has limited availability, and substitutions are utilized increasingly. Although equally efficacious in elective colon procedures, cefotetan used as surgical prophylaxis was associated with lower hospitalization costs than cefazolin plus metronidazole.

Infection after elective colorectal surgery: bacteriological analysis of failures in a randomized trial of cefotetan vs. ertapenem prophylaxis.

BACKGROUND: A randomized study comparing single-dose cefotetan and ertapenem prophylaxis for elective colorectal surgery in 1,002 patients found ertapenem to be significantly more effective (p < 0.001). Failures of prophylaxis were thought to involve organisms resistant to both antimicrobial agents, isolated most often from deep or superficial incision sites. METHODS: Further testing and analysis of the microbial data was performed. Susceptibility results were correlated with the clinical outcomes reported previously. RESULTS: Of the 216 aerobes tested, 62.6% were resistant to cefotetan and 44% to ertapenem. Enterococci and methicillin-resistant Staphylococcus epidermidis were the aerobes recovered most frequently, and Bacteroides thetaiotaomicron, Clostridium innocuum, and Eubacterium lentum were the most frequent anaerobes. Enterococcus faecalis usually was associated in mixed culture with Bacteroides fragilis group species. Approximately one-half of the 158 anaerobes (50.7%), including all the species above, were resistant to cefotetan; most of these (61.4%) came from superficial incision sites. Only one anaerobe (Desulfovibrio fairfieldensis), found in a superficial incisional infection, was resistant to ertapenem, and no ertapenem-resistant enteric bacteria were recovered. In vitro resistance was associated with therapeutic failure. CONCLUSIONS: The in vitro activity of ertapenem was superior to that of cefotetan against all anaerobic and many aerobic bacteria isolated from postoperative cultures of patients who failed prophylaxis with these agents. Our findings help to elucidate the results of the clinical trial.

Definitive risk factors for anastomotic leaks in elective open colorectal resection.

HYPOTHESIS: Anastomotic leaks following elective colorectal resections increase morbidity, mortality, and the need for additional interventions. An accurate understanding of risk factors would potentially reduce anastomotic leaks and/or allow appropriate selection of patients for diverting stomas. DESIGN: Prospective review of patient and operative characteristics that contribute to anastomotic leaks. SETTING: Fifty-one sites within the United States (May 2002-March 2005). PATIENTS: Six hundred seventy-two patients who participated in a trial comparing preoperative antimicrobials in elective open colorectal surgery. MAIN OUTCOME MEASURES: Anastomotic leaks were diagnosed using clinical findings and were confirmed with imaging. We examined 20 variables possibly affecting anastomotic healing in univariate and multivariate analyses. RESULTS: There were 24 anastomotic leaks in 672 patients (3.6%) undergoing elective colorectal resection. There were 10 deaths (1.5%). A baseline albumin level of less than 3.5 g/dL (to convert to grams per liter, multiply by 10) (P = .04) and male sex (P = .03) were associated with anastomotic leaks in both univariate and multivariate analyses (adjusted odds ratios, 2.56 and 3.12, respectively). Increased duration of surgery (SD, 60 minutes; odds ratio, 1.53; 95% confidence interval, 1.06-2.22; P = .03) and steroid use at the time of surgery (odds ratio, 3.85; 95% confidence interval, 1.24-11.93; P = .02) were significant in univariate analysis. Surgical procedure with rectal resection; prophylaxis with ertapenem (vs cefotetan); or history of obesity, tobacco use, or diabetes was not associated with anastomotic leaks. CONCLUSIONS: Significant risk factors for anastomotic leaks include low preoperative serum albumin level, steroid use, male sex, and increased duration of surgery. Appreciation of risk factors provides a rational basis for temporary diversion.

Conservative management of postoperative Fever in gynecologic patients undergoing major abdominal or vaginal operations.

BACKGROUND: To develop a standardized protocol for management of postoperative fever in gynecology patients to decrease unnecessary diagnostic workups and empiric use of antibiotics. STUDY DESIGN: A prospective analysis of postoperative gynecology patients identified those who experienced fever (maximum temperature [T(max)] > 100.4 degrees F). Patients were triaged into low- and high-risk groups. High-risk patients were managed independent of the protocol. High-risk criteria included bowel operation, preoperative infection, immunodeficiency, indwelling vascular access, mechanical heart valves, and intensive care unit admissions. Low-risk patients were treated with observation and antipyretics. Patients with persistent or high fever, defined as T(max) > 101 degrees F for > 48 hours, were evaluated and treated based on physical examination findings. RESULTS: We evaluated 292 postoperative patients. Forty-seven percent of patients had a final diagnosis of malignancy. Sixty-four patients were high-risk and 33% of these patients experienced fever. Using the standardized protocol, 228 low-risk patients were managed. Thirty-seven of the 228 patients (16%) had fever postoperatively. Nineteen patients had low-grade fever (100.4 to 101 degrees F); none of these patients required antibiotics. Seventeen patients had fever (101.1 to 102 degrees F) and one patient had fever > 102 degrees F. Using the protocol, 6 of 37 patients (16%) were treated with antibiotics for an infectious diagnosis. CONCLUSIONS: Although postoperative fever is common in gynecologic patients, the incidence of infection is low (3%). A standardized postoperative fever protocol in low-risk gynecology patients decreases use of empiric antibiotics without compromising morbidity.

Comparative costs of ertapenem and cefotetan as prophylaxis for elective colorectal surgery.

BACKGROUND AND PURPOSE: The costs of treating surgical site infections can be considerable. There is a cost associated with the prophylactic use of antibiotics; however, the use of prophylactic agents may reduce infection rates and lengths of stay, thus offsetting the overall treatment cost and potentially generating cost savings to hospitals. This project was intended to determine the potential cost impact of using ertapenem 1 g vs. cefotetan 2 g as prophylaxis for elective colorectal surgery. METHODS: Cost analysis using efficacy data from the PREVENT clinical trial and drug acquisition and total hospital costs in 2005 dollars from Premier's Perspective Comparative Database in patients > or = 18 year of age, evaluable at four weeks after elective surgery of the colon or rectum and prophylactic treatment with ertapenem (n = 338) or cefotetan (n = 334). The primary outcome measures were the rate of prophylactic drug failure and the difference between the ertapenem and cefotetan groups in costs related to and total hospital stay. Prophylactic failure was defined as a surgical site infection, unexplained antibiotic use, or anastomotic leak. RESULTS: Prophylactic failure occurred in 28.1% of the patients receiving ertapenem and 42.8% of those receiving cefotetan (p < 0.05). The most common prophylactic failure was surgical site infection: 18.3% for ertapenem, 31.1% for cefotetan, difference (95% confidence interval) -13.0% (-19.5, -6.5%) (p < 0.05). The mean +/- standard deviation length of stay for all patients, including prophylactic successes and failures, was 7.6 +/- 6.6 days for ertapenem and 8.7 +/- 9.5 days for cefotetan. The mean per-patient cost of prophylactic drugs and hospital room and board was $15,245 with ertapenem and $17,428 cefotetan, a net difference of -$2,181. CONCLUSIONS: Ertapenem used in prophylaxis for elective colorectal operations results in a lower rate of surgical site infection and a shorter average length of stay than cefotetan. The calculated net difference in prophylactic antibiotic drug and hospital costs represents a saving of $2,181 per patient with ertapenem relative to cefotetan.

Effect of body mass index and ertapenem versus cefotetan prophylaxis on surgical site infection in elective colorectal surgery.

BACKGROUND: The effectiveness of prophylactic antibiotics in the prevention of surgical site infection (SSI) after elective colorectal surgery is dependent on many factors, including the body mass index (BMI) of the patient. In this study, the association of BMI and type of antibiotic prophylaxis with SSI was evaluated in patients undergoing elective colorectal surgery. METHOD: A post-hoc analysis was performed using data obtained from a multicenter randomized, double-blind study of 1,002 patients undergoing elective colorectal surgery who received prophylactic administration of ertapenem (1 g) or cefotetan (2 g). Among 650 evaluable patients, the effect of BMI and type of antibiotic prophylaxis on SSI rates was assessed four weeks after surgery. Mechanical bowel preparation was standardized, and no patient received oral antibiotics; intravenous antibiotics were not repeated during or after surgery. RESULTS: The majority of patients had a BMI between 18.5 and 39.9 kg/m2. Regardless of the type of prophylaxis, SSI rates were significantly higher in patients with a BMI > or = 30 kg/m2 than in those with a BMI < 30 kg/m2. However, failure, defined as SSI, was significantly less common after ertapenem than after cefotetan prophylaxis at both BMI < 30 kg/m2 (12.7% vs. 26.4%, respectively; difference -13.7; 95% confidence interval [CI] -21.0, -6.5) and BMI > or = 30 kg/m2 (26.7% vs. 41.9%, respectively; difference -15.3; 95% CI -28.2, -2.0). The most prevalent type of SSI was superficial incisional infection, which was more common with both treatments in patients with a BMI > or = 30 kg/m2; however, the incidence of superficial SSI was lower after ertapenem than cefotetan prophylaxis. CONCLUSION: In patients undergoing elective colorectal surgery, the incidence of SSI, specifically superficial incisional SSI, was higher in patients with a BMI > or = 30 kg/m2, regardless of the prophylactic antibiotic given. Ertapenem prophylaxis was more effective than cefotetan in the prevention of SSI at any BMI.

Polyethylene glycol versus sodium phosphate mechanical bowel preparation in elective colorectal surgery.

BACKGROUND: The type of mechanical bowel preparation (MBP) used before elective colorectal surgery remains controversial. METHODS: This post hoc analysis of a prospective randomized controlled antibiotic prophylaxis trial (ertapenem vs. cefotetan) evaluated the effect of polyethylene glycol (PEG) and sodium phosphate (SP) MBPs on the rates of postoperative surgical site infections (SSI). RESULTS: Good to excellent MBPs were observed in 281 of 303 (93%) evaluable patients for the PEG and 336 of 367 (92%) for the SP types. A higher rate of SSI was observed in the PEG (34%) than SP (24%) group (difference, 10%; 95% confidence interval, 3.4-17.2). The MBP type was a significant risk factor for SSI, with SP favored over PEG (odds ratio, .6; 95% confidence interval, .43-.85) in univariate analysis; multivariate analysis favored SP, but was not significant (odds ratio, .69; 95% confidence interval, .46-1.02). SSI was lowest with SP and ertapenem (19%) and highest with PEG and cefotetan (44%). CONCLUSIONS: SP, coupled with ertapenem antibiotic prophylaxis, may improve outcomes and reduce SSIs in patients undergoing elective colorectal surgery when compared with PEG coupled with cefotetan antibiotic prophylaxis.

Ertapenem versus cefotetan prophylaxis in elective colorectal surgery.

BACKGROUND: Ertapenem, a long-acting carbapenem, may be an alternative to the recommended prophylactic antibiotic cefotetan. METHODS: In this randomized, double-blind trial, we assessed the efficacy and safety of antibiotic prophylaxis with ertapenem, as compared with cefotetan, in patients undergoing elective colorectal surgery. A successful outcome was defined as the absence of surgical-site infection, anastomotic leakage, or antibiotic use 4 weeks postoperatively. All adverse events were collected until 14 days after the administration of antibiotic prophylaxis. RESULTS: Of the 1002 patients randomly assigned to study groups, 901 (451 in the ertapenem group and 450 in the cefotetan group) qualified for the modified intention-to-treat analysis, and 672 (338 in the ertapenem group and 334 in the cefotetan group) were included in the per-protocol analysis. After adjustment for strata, in the modified intention-to-treat analysis, the rate of overall prophylactic failure was 40.2% in the ertapenem group and 50.9% in the cefotetan group (absolute difference, -10.7%; 95% confidence interval [CI], -17.1 to -4.2); in the per-protocol analysis, the failure rate was 28.0% in the ertapenem group and 42.8% in the cefotetan group (absolute difference, -14.8%; 95% CI, -21.9 to -7.5). Both analyses fulfilled statistical criteria for the superiority of ertapenem. In the modified intention-to-treat analysis, the most common reason for failure of prophylaxis in both groups was surgical-site infection: 17.1% in the ertapenem group and 26.2% in the cefotetan group (absolute difference, -9.1; 95% CI, -14.4 to -3.7). In the treated population, the overall incidence of Clostridium difficile infection was 1.7% in the ertapenem group and 0.6% in the cefotetan group (P=0.22). CONCLUSIONS: Ertapenem is more effective than cefotetan in the prevention of surgical-site infection in patients undergoing elective colorectal surgery but may be associated with an increase in C. difficile infection. (ClinicalTrials.gov number, NCT00090272 [ClinicalTrials.gov].).

Radiation recall dermatitis with cefotetan: a case study.

Radiation recall dermatitis (RRD) is an inflammatory skin reaction that occurs in a previously irradiated body part following drug administration. This phenomenon may occur from days to years following exposure to ionizing radiation. The case of a 54-year-old Caucasian woman who was initially treated with external-beam radiation to the right thoracic region following the diagnosis of a poorly differentiated squamous cell carcinoma of the right lung is reported. She received four cycles of consolidated chemotherapy with docetaxel and carboplatin. Four months later, she was admitted to the hospital for acute cholecystitis and was placed on cefotetan. She developed a tender, erythematous rash on the posterior region of her right thorax 48 hours later. The drug was withdrawn, supportive care was instituted, and the patient subsequently improved. RRD should be suspected in patients who develop an erythematous rash in a previously irradiated region. To our knowledge this entity has not been associated with cefotetan previously.

Fitz-Hugh-Curtis syndrome: a diagnosis to consider in women with right upper quadrant pain.

Fitz-Hugh-Curtis syndrome--inflammation of the liver capsule associated with genital tract infection--occurs in up to one fourth of patients with pelvic inflammatory disease (PID). Classically presenting as sharp, pleuritic right upper quadrant pain, usually but not always accompanied by signs of salpingitis, it can mimic many other common disorders such as cholecystitis and pyelonephritis.

Antibiotics in tactical combat casualty care 2002.

Care of casualties in the tactical combat environment should include the use of prophylactic antibiotics for all open wounds. Cefoxitin was the antibiotic recommended in the 1996 article "Tactical Combat Casualty Care in Special Operations." The present authors recommend that oral gatifloxacin should be the antibiotic of choice because of its ease of carriage and administration, excellent spectrum of action, and relatively mild side effect profile. For those casualties unable to take oral antibiotics because of unconsciousness, penetrating abdominal trauma, or shock, cefotetan is recommended because of its longer duration of action than cefoxitin.

Randomized clinical trial of extended spectrum antibiotic prophylaxis with coverage for Ureaplasma urealyticum to reduce post-cesarean delivery endometritis.

OBJECTIVE: To determine if extended spectrum prophylactic antibiotic treatment (with efficacy against Ureaplasma urealyticum) reduces post-cesarean delivery clinical endometritis. METHODS: After cord clamping at cesarean delivery, subjects received prophylaxis with cefotetan. Subjects were then simultaneously randomized (double blind) to receive doxycyline plus azithromycin versus placebo. Post-cesarean delivery endometritis was defined clinically as fever of 100.4F or higher with one or more supporting clinical signs or a physician diagnosis of endometritis plus the absence of a nonpelvic source of fever. RESULTS: A total of 597 women were enrolled, 301 in the doxycycline/azithromycin group and 296 in the placebo group. The study population was 56% black, 25.5 +/- 6.2 years of age, and 43% nulliparous. The groups were similar (P >.05) for black race, parity, maternal age, and most risk factors for post-cesarean delivery endometritis. The frequency of post-cesarean delivery endometritis (16.9% versus 24.7%, P =.020), wound infections (0.8% versus 3.6%, P =.030), and a combination of these two outcomes (19.0% versus 27.8%, P =.019) were significantly lower in the doxycycline/azithromycin group compared with the placebo-treated group. The doxycycline/azithromycin versus placebo groups were dissimilar for maternal leukocytosis (24.9% versus 12.5%, P =.042) and frequency of classic uterine incision (7.6% versus 12.5%, P =.048). Adjusting for these factors did not alter the risk ratio for post-cesarean delivery endometritis in the active versus placebo-treated group (relative risk 0.65, 95% confidence interval 0.43, 0.98). Length of stay was longer in the placebo group overall (104 +/- 56 versus 95 +/- 32 hours, P =.016) and among women with endometritis (146 +/- 52 versus 127 +/- 46 hours, P =.047). CONCLUSION: Extended spectrum prophylactic antibiotic treatment (with presumed efficacy against U urealyticum) given to women undergoing cesarean delivery at term shortens hospital stay and reduces the frequency of post-cesarean delivery endometritis and wound infections.