Consensus development of quality standards.
Explore the source record for details and available documents.
Consensus Statements as Topic↗
Biomedical subjects
E P Dellinger
Publications and source records attributed to E P Dellinger.
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
Anti-Bacterial Agents↗
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.
Anti-Bacterial Agents↗
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.
Cross Infection↗
Purpose of quality standards for infectious diseases. Infectious Diseases Society of America.
Explore the source record for details and available documents.
Humans↗
Quality standard for antimicrobial prophylaxis in surgical procedures. 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 in conjunction 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 weighted 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 diseases and 10 experts in surgical infectious diseases 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 Diseases Society of America (IDSA) developed the standard. The subcommittee was composed of representatives of the IDSA (P.A.G. and J.E.M.), the Society for Hospital Epidemiology of America (R.P.W.), the Surgical Infection Society (E.P.D.), the Pediatric Infectious Diseases Society (P.J.K.), the Centers for Disease Control and Prevention (W.J.M.), the Obstetrics and Gynecology Infectious Diseases Society (R.L.S.), and the Association of Practitioners of Infection Control (T.
Anti-Bacterial Agents↗
Quality standard for the treatment of bacteremia. 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%-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 that is 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 cases of bacteremia 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 for 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 (P.A.G. and J.E.M.), the Society for Hospital Epidemiology of America (R.P.W.), the Surgical Infection Society (E.P.D.), the Pediatric Infectious Diseases Society (P.J.K.), the Centers for Disease Control and Prevention (W.J.M.), the Obstetrics and Gynecology Infectious Diseases Society (R.L.S.), and the Association of Practitioners of Infection Control (T.L.B.). Funding was provided by the IDSA and the other cooperating organizations. The standard is endorsed by the IDSA.
Anti-Bacterial Agents↗
Quality standard for assurance of measles immunity among health care workers. 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 vaccine 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 from the fields of 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 vaccinees 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 the 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 (P.A.G. and J.E.M.), the Society for Hospital Epidemiology of America (R.P.W.), the Surgical Infection Society (E.P.D.), the Pediatric Infectious Diseases Society (P.J.K.), the Centers for Disease Control and Prevention (W.J.M.), the Obstetrics and Gynecology Infectious Diseases Society (R.L.S.), and the Association of Practitioners of Infection Control (T.L.B.). Funding was provided by the IDSA and the other cooperating organizations. The standard is endorsed by the IDSA.
Cross Infection↗
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.
Abdomen↗
Perioperative antibiotic prophylaxis and wound infection following breast surgery.
The effectiveness of perioperative antibiotic prophylaxis against wound infections following breast surgery was investigated by meta-analysis of published data from a randomized clinical trial and an observational data set, which included a total of 2587 surgical procedures, including excisional biopsy, lumpectomy, mastectomy, reduction mammoplasty and axillary node dissection. There were 98 wound infections (3.8%). Prophylaxis was used for 44% (1141) of these procedures, cephalosporins accounted for 986 (86%) of these courses of antibiotics. Prophylaxis prevented 38% of infections, after controlling for operation type, duration of surgery and participation in the randomized trial (Mantel-Haenszel Odds Ratio = 0.62, 95% confidence interval = 0.40-0.95, P = 0.03). There was no significant variation in efficacy according to operation type or duration. We conclude that antibiotic prophylaxis significantly reduces the risk of postoperative wound infection following these commonly performed breast procedures.
Anti-Bacterial Agents↗
Acute ethanol intoxication increases the risk of infection following penetrating abdominal trauma.
Acute alcohol (ETOH) intoxication as a risk factor for infection in trauma victims to our knowledge has not been previously reported. To determine if ETOH intoxication increases infection risk we examined data from 365 patients with penetrating abdominal trauma who were enrolled in a multi-center antibiotic study. Ninety-four patients sustained an injury to a hollow viscus. To separate acute from chronic ETOH effects, infections were divided into two categories: (1) trauma related; infections caused by bacterial contamination at the time of injury, while blood alcohol level (BAL) was elevated. (2) nosocomial; infections caused by bacteria acquired during hospital stay, after BAL had normalized. A BAL > or = 200 mg/dL was associated with a 2.6-fold increase in trauma-related infections. There was no association between BAL and subsequent nosocomial infection. Since infection rates for intoxicated patients were not higher after BAL had normalized, acute rather than chronic effects of ETOH appear to be responsible.
Abdominal Injuries↗
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.
Abdomen↗
Prophylaxis against wound infection following herniorrhaphy or breast surgery.
The effect of perioperative antibiotic prophylaxis on definite wound infections was assessed for 3202 herniorrhaphies or selected breast surgery procedures. Patients were identified preoperatively and monitored for greater than or equal to 4 weeks. Thirty-four percent of patients (1077/3202) received prophylaxis at the discretion of the surgeon; 86 definite wound infections (2.7%) were identified. Prophylaxis recipients were at higher risk for infection, with a higher proportion of mastectomies, longer procedures, and other factors. Patients who received prophylaxis experienced 41% fewer definite wound infections (odds ratio [OR], 0.59; 95% confidence interval [CI], 0.35-0.99; P = .04) and 65% fewer definite wound infections requiring parenteral antibiotic therapy (OR, 0.35; 95% CI, 0.15-0.88; P = .02) after adjustment for duration of surgery and type of procedure. Additional adjustment for age, body mass index, the presence of drains, diabetes, and exposure to corticosteroids did not change the magnitude of this effect meaningfully. The effect of prophylaxis was similar for all procedures studied. In the absence of formal guidelines, surgeons at these institutions administered prophylaxis preferentially to patients at highest risk.
Anti-Bacterial Agents↗
Antibiotic prophylaxis of wound infections in skin surgery. Is 4 days too much?
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Cefazolin↗
Design and evaluation of clinical trials of antimicrobial agents in surgery.
Comparative trials of antibiotic therapy must be properly designed to produce meaningful results. Trials in the treatment of intra-abdominal infections are especially difficult to perform. Problems include finding adequate samples of comparable patients, establishing objective criteria by which to assess outcomes and controlling for the effects of nonexperimental factors. These difficulties are among the reasons many comparative trials of antibiotic therapy for intra-abdominal infection fail to find a difference in efficacy between the experimental regimens. Those trials that do demonstrate a therapeutic difference usually compare an adequate regimen against one that is clearly deficient; for example, one that lacks coverage of anaerobic organisms. For hospital acquired or surgical infections, the treatment regimen with the most extensive published support is the combination of an aminoglycoside and clindamycin. Single agent therapy for intra-abdominal infections may also be appropriate. Further clinical studies are needed, but two of the most promising agents are ticarcillin and clavulanic acid and imipenem and cilastatin.
Abdomen↗
Perioperative antibiotic prophylaxis for herniorrhaphy and breast surgery.
We assessed the efficacy of perioperative antibiotic prophylaxis for surgery in a randomized, double-blind trial of 1218 patients undergoing herniorrhaphy or surgery involving the breast, including excision of a breast mass, mastectomy, reduction mammoplasty, and axillary-node dissection. The prophylactic regimen was a single dose of cefonicid (1 g intravenously) administered approximately half an hour before surgery. The patients were followed up for four to six weeks after surgery. Blinding was maintained until the last patient completed the follow-up and all diagnoses of infection had been made. The patients who received prophylaxis had 48 percent fewer probable or definite infections than those who did not (Mantel-Haenszel risk ratio, 0.52; 95 percent confidence interval, 0.32 to 0.84; P = 0.01). For patients undergoing a procedure involving the breast, infection occurred in 6.6 percent of the cefonicid recipients (20 of 303) and 12.2 percent of the placebo recipients (37 of 303); for those undergoing herniorrhaphy, infection occurred in 2.3 percent of the cefonicid recipients (7 of 301) and 4.2 percent of the placebo recipients (13 of 311). There were comparable reductions in the numbers of definite wound infections (Mantel-Haenszel risk ratio, 0.49), wounds that drained pus (risk ratio, 0.43), Staphylococcus aureus wound isolates (risk ratio, 0.49), and urinary tract infections (risk ratio, 0.40). There were also comparable reductions in the need for postoperative antibiotic therapy, non-routine visits to a physician for problems involving wound healing, incision and drainage procedures, and readmission because of problems with wound healing. We conclude that perioperative antibiotic prophylaxis with cefonicid is useful for herniorrhaphy and certain types of breast surgery.
Bacterial Infections↗
Pathogenicity of the enterococcus in surgical infections.
The enterococcus has been relegated to a position of unimportance in the pathogenesis of surgical infections. However the increasing prevalence and virulence of these bacteria prompt reconsideration of this view, particularly because the surgical patient has become increasingly vulnerable to infectious morbidity due to debility, immunosuppression, and therapy with increasingly potent antibiotics. The enterococcus is a versatile opportunistic nosocomial pathogen, causing such diverse infections as wound, intra-abdominal, and urinary tract infections; catheter-associated infection; suppurative thrombophlebitis; endocarditis; and pneumonia. Although surgical drainage remains the cornerstone of therapy for enterococcal infections involving a discrete focus, in the circumstances typified by the compromised surgical patient, specific antibacterial therapy directed against the enterococcus is warranted. Recent evidence indicates that parenteral antibiotic therapy for enterococcal bacteremia is mandatory and that appropriate therapy clearly reduces the number of deaths.
Cross Infection↗
Results of a multicenter trial comparing imipenem/cilastatin to tobramycin/clindamycin for intra-abdominal infections.
We designed a multicenter study to compare tobramycin/clindamycin to imipenem/cilastatin for intra-abdominal infections. We included the Acute Physiology and Chronic Health Evaluation (APACHE II) index of severity and excluded patients without established infection. Two hundred ninety patients were enrolled, of whom 162 were evaluable. Using logistic regression to analyze both outcome at the abdominal site of infection and outcome as mortality, we found a significant correlation for both with APACHE II score (p less than 0.0001 for both). Next we analyzed the residual effect of treatment assignment and found a significant improvement in outcome for imipenem/cilastatin-treated patients (p = 0.043). The differences in outcome were explained by a higher failure rate for patients with gram-negative organisms for tobramycin/clindamycin-treated patients (p = 0.018). This was reflected in a significantly higher incidence of fasciitis requiring reoperation and prosthetic fascial replacement. Maximum peak tobramycin levels were analyzed for 63 tobramycin/clindamycin patients harboring gram-negative organisms. For failures the maximum peak was 6.4 +/- 1.9 micrograms/mL, and time to maximum peak was 4.6 +/- 5.2 days. For successes the maximum peak was 6.1 +/- 1.7 micrograms/mL, occurring at 3.8 +/- 2.6 days. This study supports inclusion of severity scoring in statistical analyses of outcome results and supports the notion that imipenem/cilastatin therapy improves outcome at the intra-abdominal site of infection as compared to a conventionally prescribed amino-glycoside-based regimen.
Abscess↗