Antibiotic Pharmacodynamics in Surgical Prophylaxis: an Association between Intraoperative Antibiotic Concentrations and Efficacy A score system for evaluating random control clinical trials of prophylaxis of abdominal surgical wound infection Antibiotic prophylaxis in clean surgical cases and the role of community surveillance. Use of prophylactic antimicrobial drugs to prevent postoperative wound infections. Antibiotic prophylaxis with two doses of cephalosporin in patients managed with internal fixation for a fracture of the hip. The effect of a quality improvement collaborative to improve antimicrobial prophylaxis in surgical patients: a randomized trial. De-implementation of expensive blood saving measures in hip and knee arthroplasties: study protocol for the LISBOA-II cluster randomized trial Use of prophylactic antibiotic in clean surgical cases--a prospective trial of various regimens. Indirect comparison in evaluating relative efficacy illustrated by antimicrobial prophylaxis in colorectal surgery. Effectiveness of an information technology intervention to improve prophylactic antibacterial use in the postoperative period A tale of 2 hospitals: a staggered cohort study of targeted interventions to improve compliance with antibiotic prophylaxis guidelines. Routine use of antibiotic prophylaxis in low-risk laparoscopic cholecystectomy is unnecessary: a randomized clinical trial. Comparative review of the test design Tentative Final Monograph (TFM) and EN 12791 for surgical hand disinfectants. Trials on trial. A review of trials of antibiotic prophylaxis. A new approach to the problem of surgical wound infections in clean operations. A comparison between single and double dose intravenous timentin for the prophylaxis of wound infection in elective colorectal surgery A selective antibiotic prophylaxis policy for laparoscopic cholecystectomy is effective in minimising infective complications.
ABSTRACT The objective of this study was to characterize the relationship between gentamicin concentrations during surgery and the development of wound infection following colorectal operations . Despite decades of research in surgical prophylaxis , the relationship between intraoperative antibiotic concentrations and postoperative infection and the concentrations required for effective prophylaxis have not been established . A pharmacodynamic analysis was conducted using data from a previous prospect i ve , r and omized , double-blind clinical study which compared two dosage regimens of gentamicin plus metronidazole for prophylaxis in connection with elective colorectal surgery . Univariate and multivariate analyses of risk factors for postoperative wound infection were conducted , and the relationship between intraoperative gentamicin concentrations and surgical outcome was characterized . The gentamicin concentration at the time of surgical closure was one of the strongest independent risk factors for infection ( P = 0.02 ) , along with the presence of diabetes mellitus ( P = 0.02 ) , stoma ( P = 0.04 ) , and advanced age ( P = 0.05 ) . Gentamicin concentrations at closure of less than 0.5 mg/liter were associated with an infection rate of 80 % ( representing 8 of 10 patients with concentrations below that level ) ( P = 0.003 ) . Receiver operating characteristic curve analysis identified a critical closure concentration of 1.6 mg/liter for effective surgical prophylaxis ( P = 0.002 ; sensitivity , 70.8 % ; specificity , 65.9 % ) . This study provides new and important information on antibiotic pharmacodynamics in surgical prophylaxis . It demonstrates the critical effect of the antibiotic concentration at closure on wound infection and suggests a significant association between the concentration and other well-established risk factors , like the timing of preoperative antibiotic administration and surgery duration We devised 33 rules for the evaluation of  r and om control trials ( RCT ) and used them to assess 56 RCTs listed in Index Medicus during 1980–82 on antibiotic prophylaxis of surgical wound infection . We asked 15 questions about design and conduct , 10 about analysis and 8 about presentation . Out of a maximum score of 100 only 16 papers scored over 70 , the highest being 89 and the lowest 34 . Defects in presentation were not common , and 17 papers scored over 90 per cent . Defects in analysis included the incorrect use of statistical tests and ignoring the Type II error in ‘ negative ’ trials ; only 13 papers scored over 70 per cent . Defects in design and conduct included transgressions of ethical principles , inappropriate regimens , ill‐defined end points and biased r and omization or assessment ; only 20 papers scored over 70 per cent . We conclude that there is room for improvement in the performance of RCT and that the application of the 33 rules would be helpful not only to research ers but also to editors and referees of scientific journals , and to their readers In an ongoing prospect i ve study of clean surgical procedures , patients have been examined by specialist research nurses on a minimum of three occasions during the postoperative period to determine the incidence of wound complications . Whereas a previous retrospective audit suggested a wound infection rate of 2 % , this community surveillance programme revealed the true rate as at least fourfold greater ( p less than 0.001 ) . Of these complications , more than 70 % were detected only by the surveillance programme . Immediate benefit was obtained by a reduction in all complications . Despite these improvements , a core of postoperative sepsis remained , particularly in high-risk cases . Thus , a prospect i ve , controlled , prophylactic antibiotic trial has been undertaken , in an attempt to reduce the infection rate still further . An antibiotic regimen of teicoplanin , 400 mg i.v . , given as a single dose , was chosen because of the excellent activity of this agent against staphylococci and streptococci , and also because of the long half-life which renders it suitable for single-dose administration Abstract From March 1 , 1966 through March 31 , 1967 , 525 patients on the General Surgery Service of Brooke General Hospital underwent abdominal surgery during which the gastrointestinal or the biliary tracts were open . In three ( 1.5 per cent ) of 189 patients who received prophylactically a combination of penicillin G , chloramphenicol , and methicillin before , during , and immediately after operation wound infections developed , whereas wound infections occurred in thirty-seven of 336 control patients . The difference in incidence of infection between these two groups of patients is highly significant ( p Specific groups of patients in whom the incidence of wound infections apparently was reduced significantly by prophylactic administration of antibiotics included those who underwent cholecystectomy , emergency gastric surgery for bleeding , elective gastric surgery , and emergency colostomies . In view of the high degree of statistical significance in the difference in incidence of wound infection in the totals of treated and control patients , the lack of statistically significant difference in incidence of wound infections between treated and control subgroups of patients undergoing other abdominal operations probably can be attributed to the small number of patients in these groups A prospect i ve , r and omized , double-blind study was performed to evaluate the effects of antibiotic prophylaxis on the development of a wound infection in 239 patients who had immediate stabilization of a fracture of the proximal part of the femur with a dynamic hip screw . The effects of two perioperative doses of cefotiam , given twelve hours apart , were compared with those of two doses of a placebo .  Sixteen perioperative risk factors were evaluated to determine whether it was possible to identify patients who were at risk for a wound infection . All patients were followed for a minimum of six weeks . Antibiotic prophylaxis significantly reduced the prevalence of wound infection ( p < 0.05 ) : the rate of major wound infection decreased from 5 to 1 per cent and the rate of minor wound infection , from 11 to 4 per cent . The most powerful predictors of major wound infection were the duration of the operation , the interval between the accident and admission to the hospital , and the duration of postoperative urinary catheterization . The preoperative level of serum albumin and the absolute lymphocyte count were significant predictors ( p < 0.05 ) of minor wound infection and systemic infection , respectively BACKGROUND Quality improvement collaboratives are used to improve health care quality , but their efficacy remains controversial . OBJECTIVE To assess the effects of a quality improvement collaborative on preoperative antimicrobial prophylaxis . DESIGN Longitudinal cluster r and omized trial , with the quality improvement collaborative as the intervention . SETTING United States . PARTICIPANTS 44 acute care hospitals , each of which r and omly sample d approximately 100 selected surgical cases ( cardiac , hip or knee replacement , and hysterectomy ) at both the baseline and remeasurement phases . INTERVENTION All hospitals received a comparative feedback report . Hospitals r and omly assigned to the intervention group ( n = 22 ) participated in a quality improvement collaborative comprising 2 in-person meetings led by experts , monthly teleconferences , and receipt of supplemental material s over 9 months . MEASUREMENTS Change in the proportion of patients receiving at least 1 antibiotic dose within 60 minutes of surgery ( primary outcome ) and change in the proportions of patients given any antibiotics , given antibiotics for 24 hours or less , given an appropriate drug , and given a single preoperative dose and receipt of any of the 5 measures ( secondary outcome ) . RESULTS The groups did not differ in the change in proportion of patients who received a properly timed antimicrobial prophylaxis dose ( -3.8 percentage points [ 95 % CI , -13.9 to 6.2 percentage points ] ) after adjustment for region , hospital size , and surgery type . Similarly , the groups did not differ in individual measures of antibiotic duration ; use of appropriate drug ; receipt of a single preoperative dose ; or an all-or-none measure combining timing , duration , and selection . LIMITATIONS Hospitals volunteered for the effort , thereby result ing in selection for participants who were motivated to change . Implementation of the surgical infection prevention measure reporting requirements by the Centers for Medicare & Medicaid Services and The Joint Commission may have motivated improvement in prophylaxis performance . CONCLUSION At a time of heightened national attention toward measures of antimicrobial prophylaxis performance , the trial did not demonstrate a benefit of participation in a quality improvement collaborative over performance feedback for improvement of these measures Background Despite evidence that erythropoietin and intra- and postoperative blood salvage are expensive techniques considered to be non-cost-effective in primary elective total hip and knee arthroplasties in the Netherl and s , Dutch medical professionals use them frequently to prevent the need for allogeneic transfusion . To actually change physicians ’ practice , a tailored strategy aim ed at barriers that hinder physicians in ab and oning the use of erythropoietin and perioperative blood salvage was systematic ally developed . The study aims to examine the effectiveness , feasibility and costs of this tailored de-implementation strategy compared to a control strategy . Methods / Design A cluster r and omized controlled trial including an effect , process and economic evaluation will be conducted in a minimum of 20 Dutch hospitals . R and omisation takes place at hospital level . The hospitals in the intervention group will receive a tailored de-implementation strategy that consists of four components : interactive education , feedback in educational outreach visits , electronically sent reports on hospital performance ( all aim ed at orthopedic surgeons and anesthesiologists ) , and information letters or emails aim ed at other involved professionals within the intervention hospital ( transfusion committee , OR-personnel , pharmacists ) . The hospitals in the control group will receive a control strategy ( i.e. , passive dissemination of available evidence ) . Outcomes will be measured at patient level , using retrospective medical record review . This will be done in all hospitals at baseline and after completion of the intervention period . The primary outcome of the effect evaluation is the percentage of patients undergoing primary elective total hip or knee arthroplasty in which erythropoietin or perioperative blood salvage is applied . The actual exposure to the tailored strategy and users ’ experiences will be assessed in the process evaluation . In the economic evaluation , the costs of the tailored strategy and the control strategy in relation to the difference in their effectiveness will be compared . Discussion This study will show whether a systematic ally developed tailored strategy is more effective for de-implementation of non-cost-effective blood saving measures than the control strategy . This knowledge can be used in national and international initiatives to make healthcare more efficient . It also provides more generalized knowledge regarding de-implementation strategies . Trial registration This trial is registered at the Dutch Trial Register NTR4044 In a r and omised controlled prospect i ve trial , different antibiotic regimens were evaluated as prophylaxis in wound infection following elective surgical procedures . Four hundred and four consecutive cases were divided in four groups . Two groups were allotted two different conventional postoperative antibiotic regimens while the fourth group received short term perioperative antibiotic ; group one served as control . A higher frequency of postoperative wound infection was observed in the controls . Results showed reduction in gross infection in only group III where short term perioperative antibiotic was used . Combination of penicillin and streptomycin  were not found effective , and low infection rate was observed with Cephamendole used perioperatively This paper aims to explore the potential usefulness and limitations of indirect comparisons in evaluating the relative efficacy of interventions . From a systematic review of antimicrobial prophylaxis in colorectal surgery , we identified 11 sets of r and omized trials that can be used to compare antibiotics both directly and indirectly . The discrepancy between the direct and the indirect comparison is defined as the absolute value of difference in log odds ratio . The adjusted indirect comparison has the advantages that the prognostic factors of participants in different trials can be partially taken into account and more uncertainty be incorporated into its result by providing a wider confidence interval . However , considerable discrepancies exist between the direct and the adjusted indirect comparisons . When there is no direct comparison , the adjusted indirect method may be used to obtain some evidence about the relative efficacy of competing interventions , although such indirect results should be interpreted with great caution . Further empirical and method ologic research is needed to explore the validity and generalizability of the adjusted indirect comparison for evaluating different interventions BACKGROUND A 2005 report from the Centers for Medicare and Medicaid Services and the Centers for Disease Control Surgical Infection Prevention program indicated that only 41 % of prophylactic antibacterials were correctly stopped within 24 h of the end of surgery . Electronic order sets have shown promise as a means of integrating guideline information with electronic order entry systems and facilitating safer , more effective care . OBJECTIVE The aim was to study the effectiveness of a computer-based antibacterial order set on increasing the proportion of patients who have antibacterial wound prophylaxis discontinued in the appropriate time frame . DESIGN The authors conducted a quasi-experimental interrupted time-series analysis over an 8-month study period with the implementation of a computer-based order system design ed to prevent excessive duration of surgical prophylaxis antibacterials . MEASUREMENT The primary outcome was the proportion of surgeries with antibacterials discontinued in the appropriate time frame . Additionally , we evaluated the percent of surgeries after implementation of the electronic intervention with chart documentation of infection  among surgeries where the prescriber indicated the reason for antibacterial therapy was treatment . RESULTS The computer-based order intervention significantly improved the proportion of surgeries with timely discontinuation of antibacterials from 38.8 % to 55.7 % ( p < 0.001 ) in the intervention hospital , while the control hospital remained at 56 - 57 % ( p = 0.006 for the difference between treated and control hospitals ) . In surgeries after intervention implementation where a prescriber indicated the reason for antibacterial therapy was treatment , the prevalence of chart documented infection was only 14 % . CONCLUSIONS A computer-based electronic order set intervention increased timely discontinuation of postoperative antibacterials BACKGROUND The purpose of this prospect i ve study was to determine the effectiveness of targeted interventions to improve compliance with  antibiotic prophylaxis guidelines ( timing , spectrum , and discontinuation ) at 2 university-affiliated hospitals . METHODS Based on barriers identified previously , hospital-specific interventions were developed such as educational conferences , st and ardized forms , an extended time-out , and feedback . Guideline compliance and surgical site infection ( SSI ) data were recorded on all patients who underwent elective laparotomies for colorectal procedures , vascular operations , and hysterectomies during four 6-month study periods . Pre study data from July to December 2006 served as a baseline . One year later , a prospect i ve cohort study was performed . The interventions were introduced to the 2 hospitals in a staggered fashion with 2-month implementation periods before reassessing compliance during the 6-month study periods . General linear modeling was performed ( P < .05 significant ) . RESULTS Compliance with all 3 guidelines combined improved during the year preceding the study , after attention only , at both hospitals . Hospital-specific differences were found in the effectiveness of the intervention package on individual guidelines . Hospital 2 but not 1 improved in timing after the interventions ; both hospitals improved in spectrum , and neither hospital improved in discontinuation . Overall compliance with all 3 antibiotic prophylactic measures was greater at hospital 1 , but hospital 2 had lower SSI rates . CONCLUSION Simply increasing attention to a quality problem can result in a significant and sustained improvement . Quality improvement interventions should be evaluated rigorously for effectiveness given hospital-specific differences in effectiveness and for correlation of guideline compliance with outcome BACKGROUND Laparoscopic cholecystectomy uses smaller incision and trocars that lessen the contamination and exposure of wound , result ing in less infection . However , the antibiotic prophylaxis is still widely practice d , like in our institute , a continuation of the era of open surgery . Recent studies reveal no advantage of routine use of antibiotic , and there is growing consensus against it . Besides cost , antibiotic increases emergence of multidrug resistance . Because of the controversies , we conducted this clinical trial . METHODS This r and omized clinical trial , conducted from October 1 , 2009 to September 31 , 2010 at Patan Hospital , included 154 patients in prophylactic antibiotic group ( GrAP ) with cefazolin 1 g IV  as per existing practice and 156 in  no antibiotic group ( GrAPn ) . Symptomatic laparoscopic cholecystectomy patients of American Society of Anesthesiologist ( ASA ) 1 and 2 ( without diabetes ) were included . Patients with complicated gall stones ( cholangitis , choledocholithiasis , and pancreatitis ) and who required conversion were excluded . Wound was observed during follow-up within 1 week . Data on patient characteristics , use of antibiotic , bile spillage , and postoperative wound infection were entered in pre design ed proforma . Microsoft Excel was used to analyze the data . RESULTS In total , 310 patients were eligible for analysis , 154 in GrAP and 156 in GrAPn . Both groups were comparable in patient demographic and clinical characteristics such as average age ( 40.3 vs. 41.6 years ) and sex ( female 77.6 % vs. 78.6 % ) .  Overall wound infection occurred in 4.8 % ( 15/310 ) . There was no significant difference in wound infections among the two groups ( p = 0.442 ) : GrAP 3.9 % and GrAPn 5.8 % . There was no mortality in this series . CONCLUSION Routine preoperative antibiotic prophylaxis is not necessary in low-risk symptomatic gallstone patients undergoing laparoscopic cholecystectomy Preoperative antiseptic treatment of the h and s of the surgical team is a st and ard procedure used worldwide in order to reduce the risk of surgical site infection . Two different types of antiseptics are available : alcohol-based h and rubs and antimicrobial liquid detergents ( " soaps " ) . St and ards have been developed to determine the antimicrobial efficacy of such preparations : the European norm EN 12971 , finally issued in 2005 , and the Tentative Final Monograph ( TFM ) for health care antiseptic products from 1994 , which is the corresponding document in the USA . Although both methods use the reduction of resident h and flora as a quantitative parameter for antimicrobial efficacy , there are major differences concerning the test design . Whereas the European method is carried out following a r and omized , reference-controlled crossover design , the US method can be characterized as a r and omized , blinded parallel arm design . While both st and ards aim at immediate as well as sustained efficacy of the procedure , according to the EN the test product must not be significantly less effective than the reference procedure , whereas the TFM requires absolute reduction of > or = 1 , > or = 2 , and > or = 3 log10 per h and on days 1 , 2 , and 5 , respectively . Results from various studies demonstrated that meeting the criteria defined by both st and ards may happen , but meeting the specifications of one st and ard does not necessarily mean that the same product will pass the requirements of the other . Missing accordance may be due to a number of considerable differences between both test methods . For a number of reasons the European method seems to be closer to clinical practice and to provide higher patient safety than the US method . However , available study data do neither allow for evaluation of the clinical impact of surgical h and disinfection as such nor of the effect of a particular product on postoperative wound infection rates The ability of a small-scale r and om-control clinical trial comprising less than 500 patients to disclose clinical ly important differences between treatment groups depends on the event rate in the control group . The high rate of wound infection after abdominal operations has attracted many trials of methods of antibiotic prophylaxis . We review ed all of the pertinent English literature recorded in Index Medicus in 1980 and 1981 . We examined 45 articles for defects in design , analysis , and presentation . Of the 45 articles , 25 reported statistically significant differences between treatment groups and 20 , no significant differences . Unsatisfactory methods of r and omization were used in four trials , ethics were question able in 22 , statistical methods were incorrect in 31 , and presentation was inadequate in 40 . We concluded that there is room for improvement in the conduct of clinical trials A study was made of the risk factors causing a high incidence of  surgical wound infections in clean operations . Identification of these factors in the preoperative stage allows the patients to be divided into two categories : a high risk ( about 10 % of patients for surgery ) and low risk . By giving antibiotic prophylaxis only to patients at high risk , the incidence of postoperative infections can be reduced , decreasing the number of extra days in hospital and consequently lowering costs . This is a new approach to the problem of surgical wound infections since not only is it based on the usual classification of operations into clean , clean-contaminated , contaminated and dirty , but it also takes into account the defensive capacity of the target of the infection : the patient A prospect i ve , r and omized , single-blind , controlled clinical trial was undertaken to determine whether two doses of systemic Timentin provided superior prophylaxis against postoperative sepsis in elective colorectal surgery compared with a single dose of the same antibiotic . Timentin , a combination of ticarcillin and clavulanic acid was administered intravenously ( 3.1 g ) at the commencement of operation to all patients , and this was repeated after 2 hours in those patients r and omized to receive a second dose . The wound infection rate was 11 percent in the 143 patients completing follow-up and receiving a single dose , and 13 percent in the 128 patients receiving two doses of Timentin ( P>0.05 ) . The rates of postoperative septicemia 3vs.4 percent and intra-abdominal abscess 5vs.8 percent were similar . Multivariate analysis of the factors likely to affect postoperative wound infection rate demonstrated an association with the type of hospital , public or private , wound infection rate 16 and 6 percent , respectively ( P<0.01 ) , and the surgeon group defined by the number of patients contributed greater than 25 or less than 25 , wound infection rate 6 and 18 percent , respectively ( P<0.05 ) . We concluded that a single dose of intravenous Timentin was as effective as two doses for prophylaxis against surgical infection and that the surgeon group and the hospital in which the operation took place were statistically significant predictors of postoperative wound infection INTRODUCTION It has been demonstrated previously that the identification of bactibilia during cholecystectomy is associated with the presence of one or more risk factors : acute cholecystitis , common duct stones , emergency surgery , intraoperative findings and age > 70 years . Current evidence -based guidance on antibiotic prophylaxis during  laparoscopic cholecystectomy ( LC ) is based on elective procedures and does not take into account these factors . The aim of this study was to assess the effectiveness of a selective antibiotic prophylaxis policy limited to high risk patients undergoing LC with the development of port site infections as the primary endpoint . METHODS One hundred consecutive patients undergoing LC under the care of a single consultant surgeon during a one-year period were studied prospect ively . Data collected included patient demographics ( age , sex ) as well as details of the history of gallstone disease to determine those with complex disease and risk factors for bactibilia . A single dose of antibiotics ( second generation cephalosporin and metronidazole ) was administered on induction to patients with a risk factor present . Information relating to all radiologically or microbiologically confirmed infections was documented . RESULTS Eighty-four of the patients were female and the mean age was 47.7 ±16.0 years . Nineteen LCs were performed as emergencies and the remainder were elective procedures . A risk factor for bactibilia was present in 35 patients . A wound infection was identified in four cases , two of which were Staphylococcus aureus ( one methicillin resistant ) , one was a coagulase negative Staphylococcus and one wound cultured a mixed anaerobic growth . Three of the infections occurred in patients receiving prophylaxis ( 2 staphylococcal and 1 anaerobic ) at intervals of 7 , 14 and 19 days respectively . One patient with a body mass index of 32kg/m² in the ' no prophylaxis ' group developed a coagulase negative staphylococcal infection at 10 days . No intra or extra-abdominal abdominal infections were identified . CONCLUSIONS This study has demonstrated that restricting antibiotic prophylaxis to high risk patients has no detrimental effects in terms of increasing the rate of infections in those with no risk factors . Furthermore , the act of not prescribing to low risk patients will limit costs and the risk of adverse events . It will also reduce the risk of resistance and clostridial infections in this cohort
However , there was no real evidence supporting the second hypothesis that the relative risk of wound infection would substantially vary over different levels of surgery cleanliness .
: As well as antibiotic prophylaxis being a generally effective intervention for preventing postoperative wound infection , the level of this effectiveness would appear to be reasonably independent of what type of surgery is being considered .
In particular , perhaps a sensible philosophy would be to assume that antibiotic prophylaxis is effective in reducing the risk of wound infection for all types of surgery , even ones where no clinical trial data exists and make exceptions to this rule if , for certain types of surgery , it can be proved to the contrary
CONTEXT While the main focus of a meta- analysis is often to assess the effectiveness of a particular intervention in managing or curing a specific condition , there exists a substantial amount of information within published systematic review s that could be used to assess the validity of a generic hypothesis about the effectiveness of an intervention across a range of different but related conditions .
OBJECTIVE To systematic ally search for and then collate the results of meta-analyses for the effectiveness of antibiotic prophylaxis in preventing postoperative wound infection across various types of surgery in order to assess generic hypotheses about the effectiveness of this intervention in surgery as a whole .
With the relative risk of wound infection used as the measure of clinical effectiveness , the hypotheses to be assessed were first that antibiotic prophylaxis would be an effective intervention for preventing wound infection over a broad range of different surgical procedures , and second that there would be a substantial difference in the effectiveness of antibiotic prophylaxis between " clean " and " contaminated " surgical procedures .