The effects of an aviation-style computerised pre-induction anaesthesia checklist on pre-anaesthetic set-up and non-routine events.

This prospective, observational study compared the proportion of cases with missing critical pre-induction items before and after the implementation of an aviation-style computerised pre-induction anaesthesia checklist. Trained observers recorded the availability of critical pre-induction items and evaluated the characteristics of the pre-induction anaesthesia checklist performance including provider participation and distraction level, resistance to the use of the checklist and the time required for completion. Surgical cases that met the criteria for inclusion in the National Surgical Quality Improvement Program at a single academic hospital were selected for observation. A total of 853 cases were observed before and 717 after implementation of the checklist. The proportion of cases with failure to perform all pre-induction steps decreased from 10.0% to 6.4% (p = 0.012). There was also a significant decrease in the proportion of cases with non-routine events from 1.2% cases before to none after checklist implementation (p = 0.003). In 17 cases, the checklist alerted the anaesthesia provider to correct a mistake in pre-induction preparation.

Meta-analysis of lower perioperative blood glucose target levels for reduction of surgical-site infection.

BACKGROUND: There is a clear association between hyperglycaemia and surgical-site infection (SSI). Intensive glucose control may involve a risk of hypoglycaemia, which in turn results in potentially severe complications. A systematic review was undertaken of studies comparing intensive versus conventional glucose control protocols in relation to reduction of SSI and other outcomes, including hypoglycaemia, mortality and stroke. METHODS: PubMed, Embase, CENTRAL, CINAHL and WHO databases from 1 January 1990 to 1 August 2015 were searched. Inclusion criteria were RCTs comparing intensive with conventional glucose control protocols, and reporting on the incidence of SSI. Meta-analyses were performed with a random-effects model, and meta-regression was subsequently undertaken. Targeted blood glucose levels, achieved blood glucose levels, and important adverse events were summarized. RESULTS: Fifteen RCTs were included. The summary estimate showed a significant benefit for an intensive compared with a conventional glucose control protocol in reducing SSI (odds ratio (OR) 0·43, 95 per cent c.i. 0·29 to 0·64; P < 0·001). A significantly higher risk of hypoglycaemic events was found for the intensive group compared with the conventional group (OR 5·55, 2·58 to 11·96), with no increased risk of death (OR 0·74, 0·45 to 1·23) or stroke (OR 1·37, 0·26 to 7·20). These results were consistent both in patients with and those without diabetes, and in studies with moderately strict and very strict glucose control. CONCLUSION: Stricter and lower blood glucose target levels of less than 150 mg/dl (8·3 mmol/l), using an intensive protocol in the perioperative period, reduce SSI with an inherent risk of hypoglycaemic events but without a significant increase in serious adverse events.

[Determinant-based classification of acute pancreatitis severity. International multidisciplinary classification of acute pancreatitis severity: the 2013 German edition]. / Einteilung des Schweregrads der akuten Pankreatitis. Internationale, multidisziplinäre klinische Klassifikation auf Basis pathogenetischer Determinanten: Deutsche Version 2013.

OBJECTIVE: The aim of this study was to develop a new international classification of acute pancreatitis severity on the basis of a sound conceptual framework, comprehensive review of published evidence, and worldwide consultation. BACKGROUND: The Atlanta definitions of acute pancreatitis severity are ingrained in the lexicon of pancreatologists but suboptimal because these definitions are based on empiric descriptions of occurrences that are merely associated with severity. METHODS: A personal invitation to contribute to the development of a new international classification of acute pancreatitis severity was sent to all surgeons, gastroenterologists, internists, intensive medicine specialists, and radiologists who are currently active in clinical research on acute pancreatitis. The invitation was not limited to members of certain associations or residents of certain countries. A global Web-based survey was conducted and a dedicated international symposium was organised to bring contributors from different disciplines together and discuss the concept and definitions. RESULT: The new international classification is based on the actual local and systemic determinants of severity, rather than descriptions of events that are correlated with severity. The local determinant relates to whether there is (peri)pancreatic necrosis or not, and if present, whether it is sterile or infected. The systemic determinant relates to whether there is organ failure or not, and if present, whether it is transient or persistent. The presence of one determinant can modify the effect of another such that the presence of both infected (peri)pancreatic necrosis and persistent organ failure have a greater effect on severity than either determinant alone. The derivation of a classification based on the above principles results in 4 categories of severity - mild, moderate, severe, and critical. CONCLUSIONS: This classification is the result of a consultative process amongst pancreatologists from 49 countries spanning North America, South America, Europe, Asia, Oceania, and Africa. It provides a set of concise up-to-date definitions of all the main entities pertinent to classifying the severity of acute pancreatitis in clinical practice and research. This ensures that the determinant-based classification can be used in a uniform manner throughout the world.

Does Isolation of Enterococcus Affect Outcomes in Intra-Abdominal Infections?

BACKGROUND: Enterococci are isolated frequently as pathogens in patients with intra-abdominal infections (IAIs) and may predict poor clinical outcomes. It remains controversial whether enterococci warrant an altered treatment approach with regard to antimicrobial treatment. PATIENTS AND METHODS: The study population was derived from the Study to Optimize Peritoneal Infection Therapy (STOP-IT) trial database. Through post hoc analysis subjects were stratified into two groups based on isolation of Enterococcus. Fifty subjects of the cohort (n = 518) had Enterococcus isolated. Uni-variable and multi-variable analyses were conducted to determine whether isolation of Enterococcus constituted an independent predictor of the pre-defined STOP-IT composite outcome (surgical site infection, recurrent IAI, or death) and the individual components of the composite outcome. RESULTS: From the cohort of 50 subjects, we identified 52 isolates of Enterococcus spp. with a predominance of Enterococcus faecalis (40%) followed by other Enterococcus spp. (37%) and Enterococcus faecium (17%). Baseline demographic characteristics were statistically similar between the two groups. Antibiotic utilization distribution remained balanced between the Enterococcus and no Enterococcus groups with the majority receiving piperacillin-tazobactam (62% and 54%, respectively). The groups had comparable infection characteristics including setting of acquisition (>50% community acquired) and origin of infection (predominantly colon or rectum). Individual and composite clinical outcomes were not different statistically between the Enterococcus and no Enterococcus groups: surgical site infection (10% vs. 7.5%; p = 0.53), recurrent IAI (20% vs. 14.1%; p = 0.26), death (2% vs. 1%; p = 0.40), and composite of all three (30% vs. 20.9%; p = 0.14], respectively. Multi-variable analysis revealed that isolation of Enterococcus did not predict independently the incidence of the composite outcome (odds ratio [OR] 1.53 [95% confidence interval {CI} = 0.78-3.01]; p = 0.22; c-statistic = 0.65; goodness of fit, p = 0.71). CONCLUSIONS: Enterococcus was not a more common pathogen in health-care-associated IAIs and was not an independent risk factor for the composite outcome. The isolation of Enterococcus from IAIs may not warrant an alternative treatment approach but larger studies are needed to validate these findings.

Age and Its Impact on Outcomes with Intra-Abdominal Infection.

BACKGROUND: Age has been shown to play a significant role in the etiology of complicated intra-abdominal infections (cIAIs), but the correlation between age and outcomes after therapy was not investigated in the Study to Optimize Peritoneal Infection Therapy (STOP-IT) trial. PATIENTS AND METHODS: Data were obtained by post hoc analysis of the STOP-IT trial database. Patients were stratified by age <65 or ≥65 years. Primary outcomes were surgical site infection (SSI), recurrent IAI (recIAI), and death. Multivariable analysis was performed to identify independent predictors of outcomes. RESULTS: There were 398 subjects <65 and 120 ≥ 65 years. Overall baseline characteristics of the two groups were similar. The site of infection was similar between groups except: Colon or rectum (48.3% vs. 29.9%, p = 0.0002) and biliary tree (16.7% vs. 9.1%, p = 0.02), which were more common in the older group, whereas small intestine (6.7% vs. 16.3%, p = 0.008) and appendix (4.2% vs.17.1%, p = 0.0004) were more common in the younger group. Among the primary outcomes, only death was significantly different between the age groups and was more prevalent in the ≥65 years group (4 [3.3%] vs. 1 [0.3%], p = 0.01). Surgical site infection (9.2% vs. 7.3%, p = 0.50), recIAI (15.8% vs. 14.4%, p = 0.69), and a composite outcome (26.7% vs. 20.4%, p = 0.14) were statistically similar between the age groups, and this remained true when controlling for other co-variables. Multivariable analyses did not reveal age as an independent predictor of the composite or individual outcomes. CONCLUSION: Patients with a more advanced age demonstrated variable sources of infection relative to the younger cohort, yet received similar treatments. Patient age was not an independent predictor of the undesired cIAI outcomes. These findings suggest that advanced age itself does not play a significant role in predicting these adverse outcomes for cIAIs and does not necessitate an altered treatment tactic.

Impaired esophageal function in morbidly obese patients with gastroesophageal reflux disease: evaluation with multichannel intraluminal impedance.

BACKGROUND: Morbid obesity is associated with gastroesophageal reflux disease (GERD), and both have an independent association with motility disorders. Impaired esophageal function is thought to play a role in the development of dysphagia after fundoplication and bariatric procedures (especially restrictive procedures). The authors aimed to define both the physiology and the underlying pathophysiology of swallowing using a novel technique, multichannel intraluminal impedance (MII), which can accurately determine the clearance of a swallowed bolus through the esophagus, in combination with traditional manometry, which can measure peristalsis. METHODS: Simultaneous MII, manometry, and pH monitoring were performed for 10 asymptomatic subjects, 22 consecutive nonobese patients with GERD (GERD), and 22 consecutive morbidly obese patients with GERD (MO-GERD) who were under evaluation for antireflux and bariatric surgery at the University of Washington. In this study, MII was defined as abnormal if less than 80% of swallowed liquid boluses cleared the esophagus completely. RESULTS: All GERD and MO-GERD patients had abnormal pH monitoring. The manometric findings were similar for the GERD and MO-GERD patients. All the asymptomatic subjects had normal manometry and impedance test results. Abnormal manometry would have predicted that approximately 23% of GERD and MO-GERD patients had defective emptying. However, when measured with impedance, esophageal clearance was found to be defective in two times as many GERD and nearly three times as many MO-GERD patients. CONCLUSIONS: In patients with GERD, impedance often detects impairments in esophageal motility not identified by manometry. Morbidly obese patients with GERD have a higher incidence of impaired esophageal motility than nonobese patients with GERD. This may have implications for bariatric procedures, especially those that are restrictive.

Inclusion of Vancomycin as Part of Broad-Spectrum Coverage Does Not Improve Outcomes in Patients with Intra-Abdominal Infections: A Post Hoc Analysis.

BACKGROUND: Management of complicated intra-abdominal infections (cIAIs) includes broad-spectrum antimicrobial coverage and commonly includes vancomycin for the empiric coverage of methicillin-resistant Staphylococcus aureus (MRSA). Ideally, culture-guided de-escalation follows to promote robust antimicrobial stewardship. This study assessed the impact and necessity of vancomycin in cIAI treatment regimens. PATIENTS AND METHODS: A post hoc analysis of the Study to Optimize Peritoneal Infection Therapy (STOP-IT) trial was performed. Patients receiving piperacillin-tazobactam (P/T) and/or a carbapenem were included with categorization based on use of vancomycin. Univariate and multivariable analyses evaluated effects of including vancomycin on individual and the composite of undesirable outcomes (recurrent IAI, surgical site infection [SSI], or death). RESULTS: The study cohort included 344 patients with 110 (32%) patients receiving vancomycin. Isolation of MRSA occurred in only eight (2.3%) patients. Vancomycin use was associated with a similar composite outcome, 29.1%, vs. no vancomycin, 22.2% (p = 0.17). Patients receiving vancomycin had (mean [standard deviation]) higher Acute Physiology and Chronic Health Evaluation II scores (13.1 [6.6] vs. 9.4 [5.7], p < 0.0001), extended length of stay (12.6 [10.2] vs. 8.6 [8.0] d, p < 0.001), and prolonged antibiotic courses (9.1 [8.0] vs. 7.1 [4.9] d, p = 0.02). After risk adjustment in a multivariate model, no significant difference existed for the measured outcomes. CONCLUSIONS: This post hoc analysis reveals that addition of vancomycin occurred in nearly one third of patients and more often in sicker patients. Despite this selection bias, no appreciable differences in undesired outcomes were demonstrated, suggesting limited utility for adding vancomycin to cIAI treatment regimens.

Cimetidine clearance in the obese.

Six subjects with normal weight (mean weight = 62 kg) and six obese subjects (mean weight = 140 kg) were given a single intravenous cimetidine infusion of 600 mg over 10 to 15 minutes. Both groups of subjects had normal serum creatinine levels and were matched with respect to age, desirable body weight, height, renal function, and sex. Compared with subjects of normal weight, obese subjects had higher cimetidine systemic (1147 and 637 ml/min) and renal (808 and 318 ml/min) clearances. Volume of distribution at steady state was of the same order for the two groups (82 and 84 L), but the t 1/2 was shorter in the obese group (1.2 and 1.9 hr). Obese subjects had lower cimetidine sulfoxide serum concentrations and greater cimetidine sulfoxide renal clearance (856 and 509 ml/min). Cimetidine systemic clearance and cimetidine sulfoxide renal clearance values were of the same order in the two groups when normalized by the value of weight raised to the 0.76 and 0.5 powers. Under the assumptions of an average weight of 70 kg and that average serum concentrations produced by cimetidine, 300 mg iv every 6 hours, are appropriate, people with normal renal function and body weight usually receive 48 mg/day/weight0.76. This same dosage in obese individuals with normal serum creatinine values should result in the same average steady-state serum concentrations. In our obese subjects, the mean cimetidine dose would have been approximately 500 mg iv every 6 hours.

Quality standard for the treatment of bacteremia. The Infectious Diseases Society of America.

OBJECTIVE: The objective of this quality standard is to optimize the treatment of bacteremia in hospitalized patients by ensuring that the antibiotic given is appropriate in terms of the blood culture susceptibility of the pathogen. Although this standard may appear to be minimal in scope, it is needed because appropriate antimicrobial treatment is not given in 5% to 17% of cases. To implement the standard, physicians, pharmacists, and microbiologists will need to devise a coordinated strategy. OPTIONS: We considered criteria for appropriate dosing, most cost-effective selection, proper antibiotic levels in serum, least toxicity, narrowest spectrum, specific clinical indications, and optimal duration of treatment. All these criteria were rejected as the basis for the standard because they were too controversial and too difficult to be applied by a nonphysician chart reviewer. In contrast, the selection of an antibiotic to which the pathogen is sensitive is a noncontroversial criterion and easy for a chart reviewer to apply. OUTCOMES: The standard is designed to reduce the incidence of adverse outcomes of septicemia such as renal failure, prolonged hospitalization, and death. EVIDENCE: Several well-designed clinical trials without randomization as well as case-controlled studies have confirmed the benefit of using an antibiotic that is appropriate in light of the susceptibility of the isolate in blood culture. Prospective, randomized, placebo-controlled trials are not available. VALUES: Our premise is that the presence of bacteremia is a risk factor for serious adverse outcomes. We also believe that the administration of antibiotics must always be guided by the susceptibility report for the pathogen(s) obtained from blood cultures. This concern is more critical for pathogens from the blood than for those from most other body sites. We had evidence that susceptibility reports for pathogens from positive blood cultures were not always used properly. We used group discussion to reach a consensus among the members of the Quality Standards Subcommittee. BENEFITS, HARMS, AND COSTS: Through the implementation of this standard, at least 5% of bacteremias could be treated more appropriately. An unknown number of deaths would likely be prevented, and mortality from bacteremia treated inappropriately would probably be reduced. The primary undesirable feature of the standard is an increased workload of pharmacists and microbiologists. RECOMMENDATIONS: Treatment of bacteremia with an antibiotic that is appropriate in terms of the pathogen's blood-culture susceptibility is a minimal standard of care for all patients. VALIDATION: We consulted more than 50 experts in infectious diseases from the fields of medicine, surgery, pediatrics, obstetrics and gynecology, nursing, epidemiology, pharmacology, and government. In addition, the methods for its implementation were reviewed by the American Society of Hospital Pharmacists and were tested by one of the members of the Quality Standards Subcommittee. SPONSORS: The Quality Standards Subcommittee of the Clinical Affairs Committee of the Infectious Diseases Society of America (IDSA) developed the standard. The subcommittee was composed of representatives of the IDSA (Drs. Gross and McGowan), the Society for Hospital Epidemiology of America (Dr. Wenzel), the Surgical Infection Society (Dr. Dellinger), the Pediatric Infectious Diseases Society (Dr. Krause), the Centers for Disease Control and Prevention (Dr. Martone), the Obstetrics and Gynecology Infectious Diseases Society (Dr. Sweet), and the Association of Practitioners of Infection Control (Ms. Barrett). Funding was provided by the IDSA and the other cooperating organizations. This standard is endorsed by the IDSA.

Quality standard for antimicrobial prophylaxis in surgical procedures. The Infectious Diseases Society of America.

OBJECTIVE: The objectives of this quality standard are 1) to provide an implementation mechanism that will facilitate the reliable administration of prophylactic antimicrobial agents to patients undergoing operative procedures in which such a practice is judged to be beneficial and 2) to provide a guideline that will help local hospital committees formulate policies and set up mechanisms for their implementation. Although standards in the medical literature spell out recommendations for specific procedures, agents, schedules, and doses, other reports document that these standards frequently are not followed in practice. OPTIONS: We have specified the procedures in which the administration of prophylactic antimicrobial agents has been shown to be beneficial, those in which this practice is widely thought to be beneficial but in which compelling evidence is lacking, and those in which this practice is controversial. We have examined the evidence regarding the optimal timing of drug administration, the optimal dose, and the optimal duration of prophylaxis. OUTCOMES: The intended outcome is more uniform and reliable administration of prophylactic antibiotics in those circumstances where their value has been demonstrated or their use has been judged by the local practicing medical community to be desirable. The result should be a reduction in rates of postoperative wound infection with a limitation on the quantities of antimicrobial agents used in circumstances where they are not likely to help. EVIDENCE: Many prospective, randomized, controlled trials comparing placebo with antibiotic and comparing one antibiotic with another have been conducted. In addition, some trials have compared the efficacy of different doses or methods of administration. Other papers have reported on the apparent efficacy of administration at different times and on actual practice in specific communities. Only a small group of relevant articles found through 1993 are cited herein. When authoritative reviews are available, these--rather than an exhaustive list of original references--are cited. VALUES: We assumed that reducing rates of postoperative infection was valuable but that reducing the total amount of antimicrobial agents employed was also worthwhile. The cost of and morbidity attributable to postoperative wound infections should be weighed against the cost and potential morbidity associated with excessive use of antimicrobial agents. BENEFITS, HARMS, AND COSTS: More reliable administration of antimicrobial agents according to recognized guidelines should prevent some postoperative wound infections while lowering the total quantity of these drugs used. No harms are anticipated. The costs involved are those of the efforts needed on a local basis to design and implement the mechanism that supports uniform and reliable administration of prophylactic antibiotics. RECOMMENDATIONS: All patients for whom prophylactic antimicrobial agents are recommended should receive them. The agents given should be appropriate in light of published guidelines. A short duration of prophylaxis (usually < 24 hours) is recommended. VALIDATION: More than 50 experts in infectious disease and 10 experts in surgical infectious disease and surgical subspecialties reviewed the standard. In addition, the methods for its implementation were reviewed by the American Society of Hospital Pharmacists. SPONSORS: The Quality Standards Subcommittee of the Clinical Affairs Committee of the Infectious Disease Society of America (IDSA) developed the standard. The subcommittee was composed of representatives of the IDSA (Drs. Gross and McGowan), the Society for Hospital Epidemiology of America (Dr. Wenzel), the Surgical Infection Society (Dr. Dellinger), the Pediatric Infectious Disease Society (Dr. Krause), the Centers for Disease Control and Prevention (Dr. Martone), the Obstetrics and Gynecology Infectious Diseases Society (Dr. Sweet), and the Association of Practitioners of Infection Contr

Quality standard for assurance of measles immunity among health care workers. The Infectious Diseases Society of America.

OBJECTIVE: The objective of this quality standard is to prevent nosocomial transmission of measles by assuring universal measles-mumps-rubella (MMR) vaccination of all health care workers who lack immunity to measles. Although the primary emphasis is on health care workers in hospitals, those at other sites, such as clinics, nursing homes, and schools, are also included. It will be the responsibility of designated individuals at these institutions to implement the standard. OPTIONS: We considered advocating the use of measles vaccine rather than MMR but chose the latter because it also protects against mumps and rubella and because it is more readily available. OUTCOMES: The desired outcome is a reduction in the nosocomial transmission of measles. EVIDENCE: Although direct comparative studies are lacking, nosocomial outbreaks of measles have been reported (as recently as 1992) in institutions where measles immunization of nonimmune health care workers is not universal, whereas such outbreaks have not been reported in institutions with universal immunization. VALUES AND VALIDATION: We consulted more than 50 infectious-disease experts in epidemiology, government, medicine, nursing, obstetrics and gynecology, pediatrics, and surgery. In light of disagreement regarding the implementation of the standard, we used group discussions to reach a consensus. BENEFITS, HARMS, AND COSTS: The consequences of the transmission of measles (and of mumps and rubella) in a health care institution include not only the morbidity and mortality attributable to the disease, but also the significant cost of evaluating and containing an outbreak and the serious disruption of regular hospital routines when control measures are instituted. The potential harm to health care workers after the implementation of the standard consists of untoward effects of MMR vaccine, although the reactions of vaccines should be minimal with adherence to recommended vaccination procedures. Implementation of the standard should entail no expense to health care workers; the precise cost to institutions is unknown, but the expense would be mitigated by prevention of measles outbreaks. RECOMMENDATIONS: We recommend MMR vaccination of all health care workers who lack immunity to measles. SPONSORS: The Quality Standards Subcommittee of the Clinical Affairs Committee of the Infectious Diseases Society of America (IDSA) developed the standard. The subcommittee was composed of representatives of the IDSA (Drs. Gross and McGowan), the Society for Hospital Epidemiology of America (Dr. Wenzel), the Surgical Infection Society (Dr. Dellinger), the Pediatric Infectious Diseases Society (Dr. Krause), the Centers for Disease Control and Prevention (Dr. Martone), the Obstetrics and Gynecology Infectious Diseases Society (Dr. Sweet), and the Association of Practitioners of Infection Control (Ms. Barrett). Funding was provided by the IDSA and the other cooperating organizations. The standard is endorsed by the IDSA.

Definition of the role of enterococcus in intraabdominal infection: analysis of a prospective randomized trial.

BACKGROUND: The role of enterococcus in intraabdominal infection is controversial. This study examines the contribution of enterococcus to adverse outcome in a large intraabdominal infection trial. METHODS: A randomized prospective double-blind trial was performed to compare two different antimicrobial regimens in combination with surgical or percutaneous drainage in the treatment of complicated intraabdominal infections. A total of 330 valid patients was enrolled from 22 centers in North America. RESULTS: In 330 valid patients, 71 had enterococcus isolated from the initial drainage of an intraabdominal focus of infection. This finding was associated with a significantly higher treatment failure rate than that of patients without enterococcus (28% versus 14%, p < 0.01). In addition, only Acute Physiology and Chronic Health Evaluation II score and presence of enterococcus were significant independent predictors of treatment failure when stepwise logistic regression was performed (p < 0.01 and < 0.03). Risk factors for the presence of enterococcus include age, Acute Physiology and Chronic Health Evaluation II, preinfection hospital length of stay, postoperative infections, and anatomic source of infection. There was no difference between the clinical trial treatment regimens with regard to overall failure, failure associated with enterococcus, or frequency of enterococcal isolation. CONCLUSIONS: This study is the first to report enterococcus as a predictor of treatment failure in complicated intraabdominal infections. This trial also identifies several significant risk factors for the presence of enterococcus in such infections.

Leukocytosis at termination of antibiotic therapy: its importance for intra-abdominal sepsis.

Postoperative outcomes of 31 afebrile patients who had responded to treatment for intra-abdominal sepsis were compared based on the presence or absence of leukocytosis (WBC count greater than 10,000/cu mm) at the conclusion of antibiotic therapy. In 68% of the patients who had leukocytosis, postoperative septic complications developed within two months of their operation. In patients without leukocytosis, complications developed in only 8.3%. Afebrile patients who exhibit leukocytosis but have responded clinically to treatment are at risk for postoperative infection and multisystem failure.

Design and conduct of antibiotic trials. A report of the Scientific Studies Committee of the Surgical Infection Society.

Several recent publications have identified important methodologic problems in the design and conduct of antimicrobial trials in surgery. Developed by consensus of the members of the Scientific Studies Committee of the Surgical Infection Society, this report provides broad guidelines for the construction of antimicrobial trials. The central issues identified include pretrial definition of study purpose, entry criteria, assignment device, and statistical analysis. These issues are fundamental in designing studies with an acceptable likelihood of finding differences among those antimicrobial regimens at least risk to the study subjects. The importance of stratifying patients on the basis of background condition, disease, and severity of illness is stressed. The inclusion in a study of variables that enhance the statistical power and, therefore, the believability of this study is stressed as an important means of clarifying substantial differences between therapies.

Hand infections. Bacteriology and treatment: a prospective study.

In a prospective, double-blind study, 193 patients hospitalized for established hand infections were randomized to receive either cefamandole intravenously followed by cephalexin by mouth or methicillin intravenously followed by dicloxacillin by mouth. Careful aerobic and anaerobic cultures were performed. Multiple organisms grew in cultures from 84% of the patients (over three isolates per infection on average). Human bite wounds contained anaerobes 43% of the time compared with 12% for other wounds. The majority of wounds (72%) required operative treatment. In 128 patients assessable for treatment outcome, results were unsatisfactory in 11 (9%). There was no difference in outcome between cefamandole (6/59, 10%) and methicillin (5/59, 8%). The presence of anaerobes, Eikenella corrodens, human bites, or an increasing number of organisms was associated with an unsatisfactory response. The presence of Staphylococcus aureus and/or beta-hemolytic streptococci was associated with a favorable response. The incidence of antibiotic-resistant isolates did not correlate with outcome.

Efficacy of short-course antibiotic prophylaxis after penetrating intestinal injury. A prospective randomized trial.

Infection is the leading cause of morbidity and mortality occurring more than 48 hours after penetrating abdominal injury. Antibiotics are routinely administered to patients with penetrating intestinal injuries and are usually given for five days or more. We randomized 116 patients with confirmed penetrating injuries of the colon and/or small bowel to receive either 12 hours or five days of antibiotics. Age, sex, weapon, severity of injury, and other risk factors were evenly distributed between groups. Twenty-one patients (18%) developed trauma-related infections, 28 (24%) any infection, and three (2.6%) died. There were no significant differences between groups in any category of outcome. For patients with penetrating intestinal or colonic injury, a 12-hour course of antibiotics is as effective as a five-day course and has the advantage of lower cost and, theoretically, fewer side effects.

Surgical Infection Society intra-abdominal infection study. Prospective evaluation of management techniques and outcome.

This prospective, open, consecutive, nonrandomized trial examined management techniques and outcome in severe peritonitis. A total of 239 patients with surgical infection in the abdomen and an APACHE (acute physiology and chronic health evaluation) II score greater than 10 were studied. Seventy-seven patients (32%) died. Reoperation had a 42% mortality rate (35 of 83 patients died) compared with a 27% mortality rate (42 of 156 died) in patients who did not undergo reoperation. Forty-six patients underwent one reoperation; 15, two reoperations; 10, three reoperations; five, four reoperations; and seven, five reoperations, with mortality rates of 43%, 40%, 30%, 40%, and 57%, respectively. There was no significant difference in mortality between patients treated with a "closed-abdomen technique" (31% mortality) and those treated with variations of the "open-abdomen" technique (44% mortality). Logistic regression analysis showed that a high APACHE II score, low serum albumin level, and high New York Heart Association cardiac function status were significantly and independently associated with death. Low serum albumin level, youth, and high APACHE II score were significantly and independently associated with reoperation.

Guidelines for clinical care: anti-infective agents for intra-abdominal infection. A Surgical Infection Society policy statement.

Several antibiotics have been marketed for therapeutic use in intra-abdominal infection. Often, these agents do not provide a sufficient spectrum activity against both facultative and obligate anaerobic gram-negative organisms, or have certain toxic effects that would not otherwise support their use. Guidelines have been developed for selection of antibiotic therapy for intra-abdominal infections and are presented as a statement of the Surgical Infection Society endorsed by the Executive Council. These guidelines are restricted to infections derived from the gastrointestinal tract and deal with those microorganisms commonly seen in such infections. The recommendations are based on in vitro activity against enteric bacteria, experience in animal models, and documented efficacy in clinical trials. Other concerns regarding pharmacokinetics, mechanisms of action, microbial resistance, and safety were also used in the formation of these guidelines. For community-acquired infections of mild to moderate severity, single-agent therapy with cefoxitin, cefotetan, or cefmetazole or ticarcillin-clavulanic acid is recommended. For more severe infections, single-agent therapy with carbapenems (imipenem/cilastatin) or combination therapy with either a third-generation cephalosporin, a monobactam (aztreonam), or an aminoglycoside plus clindamycin or metronidazole is recommended. Regimens with little or no activity against facultative gram-negative rods or anaerobic gram-negative rods are not considered acceptable.

Risk of infection after open fracture of the arm or leg.

Two hundred forty consecutive patients admitted for operative treatment of an open fracture of the arm or leg were followed up prospectively for the development of fracture infection. The independent risk of fracture infection was increased in patients with grade IIIB or IIIC fractures, internal or external fixation, lower-leg fracture, any blood transfusion, or injuries resulting from motorcycle accidents or motor vehicle-pedestrian accidents. By stepwise multivariate logistic regression, the most significant risk factors were the grade of the fracture, internal or external fixation, and fractures of the lower leg. These risk factors all represent local wound characteristics, and we conclude that the most important actions by the surgeon to prevent infection involve local wound care. There was no relation between the timing of antibiotic administration or duration of antibiotic therapy and infection risk.

Failure of cimetidine prophylaxis in the critically ill.

Stress ulcers with subsequent hemorrhage are a well-recognized cause of morbidity and mortality in patients hospitalized for other serious illnesses. In 39 critically ill patients, cimetidine was used as a prophylaxis against stress ulcers with the intent to keep the gastric pH level above 4. In 11 of the 39 patients, cimetidine alone did not effect consistent elevation of the gastric pH level above 4. Of the 11 patients, nine had positive blood cultures or clinical infection and five also developed renal failure. Five comatose patients never had pH greater than 4 on cimetidine alone. The mortality for those whose conditions failed to respond to cimetidine was five times greater than for those whose conditions responded to cimetidine. These data imply that a high-risk group of patients can be identified whose conditions may not respond to cimetidine treatment and whose gastric pH must be regularly monitored.