Inappropriate surgical chemoprophylaxis and surgical site infection rate at a tertiary care teaching hospital.
As Sir Alexander Fleming predicted in his Nobel Lecture, "Antimicrobials, since their introduction have been pivotal in the prevention and treatment of infections. However, the increasing use of antimicrobials has led to a situation of appropriate and inappropriate use." (1) A surgical site infection (SSI) (2) is an infection that occurs after surgery in the part of the body where the surgery took place. Surgical site infections remain among the main causes of post-operative morbidity, prolonging hospitalization and increasing the cost of medical treatment in surgical units. (3-4) Antimicrobials play an important role in preventing and treating surgical site infections. Surgical chemoprophylaxis is an important measure before any surgery to prevent SSI. Various guidelines (5-8) are available for the use of antimicrobials for surgical chemoprophylaxis. However it is observed that they are not always followed. (9,10) This has led to a worldwide emergence of antimicrobial resistance, a major public health problem and has significant impact on treatment and outcomes. To produce the desired effect, antimicrobials have to be safe, efficacious and have to be used rationally. Several studies have evaluated pattern of use of antimicrobials as surgical chemoprophylaxis, but there are very limited studies in recent years on evaluation of rationality. Kunin's criteria are rationality based evaluation of use of antimicrobials. This methodology is based on local prescribing patterns and allows for individual evaluation of each prescription as opposed to developing general criteria/categories of infections and appropriate antimicrobial use to evaluate the quality of prescribing by audits. In the past, the classification was mainly based on the authority of infectious diseases specialists who performed the evaluation. (11) Several studies have reported SSI rate or pattern of surgical chemoprophylaxis but have not correlated SSI rates with pattern of surgical chemoprophylaxis. (12-17)
This study was undertaken to evaluate the pattern and rationality of antimicrobial drug prescribing by surgeons in perioperative patients using Kunin's criteria. (11) SSI rate was calculated and difference among patients with appropriate and inappropriate surgical chemoprophylaxis was also analyzed. The aim of this study was to evaluate the current pattern of surgical chemoprophylaxis among patients undergoing surgical procedures in a tertiary care hospital and its impact on SSI rate.
Objectives of study
1. To assess the current pattern of surgical chemoprophylaxis and its rationality assessment based on Kunin's criteria (11) and Scottish Intercollegiate Guidelines Network (SIGN) (6) core indicators for auditing antimicrobial use in surgical chemoprophylaxis.
2. To evaluate surgical site infection rate and difference in SSI rate if any between appropriate and inappropriate prescriptions.
Materials and methods
Two hundred and twenty prescriptions of patients admitted in the General Surgery wards of a tertiary teaching hospital were collected prospectively between June 2010 and May 2011. The study protocol, pro-forma, and other documents like patient information sheet and informed consent form in English and local vernacular language were approved by Institutional Ethics Committee. All patients undergoing surgery irrespective of their age and gender were included. Patients who were not willing to give information were excluded from the study. Case records of enrolled patients, admitted for any operative procedures were recorded in the pro-forma containing demographic details, chief complaints, diagnosis, details of operative procedures and drug details during the hospital stay. Class of operation was decided in consultation with operating surgeons and was based on US National Research Council group criteria. (18) SSI rate was calculated as defined by CDC, (2) rationality assessment was done according to the Kunin's criteria (11) shown in Table 1 based on CDC 1999 Guidelines (5) as reference standard and also surgical audit based on SIGN guideline criteria. (6) The analysis was done based on CDC guidelines because of unavailability of national or local guidelines. The generic names of drugs, generic contents of each formulation were obtained from the patient's pharmacy bills. Drugs and formulations which were not mentioned in the bills were obtained from local pharmacy stores and commercial publications like Indian Drug Review 2010 and 2011.
Data were analyzed by using SPSS 20.0 demo version[R]. Fisher's exact test (two tailed) was used to determine the significance of SSI positive rates among different variables and unpaired t-test was used to determine the difference between the inappropriate and appropriate prescription groups. Value of p < 0.05 was considered as statistically significant.
A total of 220 patients were enrolled in the study of which 141 (64.1%) were males. The age ranges from 13 to 78 years; with mean age 38.88 [+ or -] 14.18 (mean [+ or -]S.D.). About 90% (197) underwent elective surgeries the rest being emergency surgeries. Most of the operative procedures were open 207 (94%) and the rest were laparoscopic. General anesthesia was used in 8 patients and in the rest either spinal or local anesthesia was used. Herniorrhaphy (27.3%) and appendectomy (20.5%) remained the most frequently performed operative procedures. Class I, i.e., clean surgeries 105 (47.73%) were most frequent, followed by class II, i.e., clean-contaminated 53 (24.09%), class III-contaminated 38 (17.27%), and class IV-dirty 24 (10.91%) as shown in Table 2. Mean hospital stay was 8.67 [+ or -] 5.17 days (mean [+ or -] S.D.).
All the patients undergoing operative procedures received single intravenous dose of antimicrobial 30 min before the surgery, followed by post-operative intravenous therapy and further oral therapy with antimicrobial. Mean duration for preoperative intravenous antimicrobial therapy was 0.75 [+ or -] 0.45 days. Mean duration of post-operative intravenous antimicrobial therapy was 3.33 [+ or -] 2.24 while post-operative oral antimicrobial therapy was 4.58 [+ or -] 3.34 days. None of the operative procedures exceeded more than 4h duration.
A total of 2294 drugs were prescribed out of which 840 (36.61%) were antimicrobials. Ceftriaxone was the most frequently used antimicrobial pre-operatively (50.64%) and post-operatively (36.93%) as shown in Fig. 1.
Out of 220 patients, 28 had suspected SSI. Nineteen patients out of 28 had microbiologically confirmed SSI, Escherichia coli (9) and Staphylococcus aureus (7) being the common pathogens. SSI rate was highest in class IV (41.66%) followed by in class III (7.69%), II (7.54%), and was least in class I (1.92%). SSI rate was significantly higher in patients who presented with diabetes mellitus (p < 0.0001) and hypertension (p = 0.0048) as shown in Table 3. SSI positive rate in 61 hernia patients was 2 (1.63%) while in 45 appendectomy patients the rate was 1 (2.22%). In these patients E. coli was the most common isolate. Mean age of SSI positive patients was found significantly higher as compared to SSI negative patients (p < 0.001) which is depicted in Table 3. Patients with age above 40 years showed significant higher SSI positive rate as compared to patients less than 40 years. There was no significant difference for SSI rate between gender, types of anesthesia and between open and laproscopic surgery, while emergency surgery showed significantly higher SSI rate in comparison with elective surgery (p = 0.0073). Mean hospital stay for SSI negative patients was 7.81 [+ or -] 4.1 and that for SSI positive patient was 17.79 [+ or -] 6.41, which shows a significant increase in mean hospital stay by 9.98 days (p < 0.0001). Patients with hospital stay greater than a week had significantly higher rate (p < 0.0001) of SSI positivity. Mean drugs prescribed in SSI negative were 7.43 [+ or -] 1.74 and that in SSI positive patient was 11 [+ or -] 2 yielding a significant (p < 0.0001) increase of 3.57 drugs.
Antimicrobial prescriptions were categorized as appropriate (I and II)--105(47.7%) and inappropriate (III, IV, and V) 115 (52.3%) based on Kunin's criteria (11) as shown in Table 4. SSI rate was significantly higher (p <0.05), in inappropriate group (13.04%) in comparison with appropriate group (3.8%) as shown in Table 4. Out of 61 hernia patients, 19 prescriptions were inappropriate out of which 2 patients had SSI (p = 0.0934). Out of 45 appendectomy patients 35 prescriptions were inappropriate and one patient has SSI (p = 1). Rate of SSIs in patients who receive inappropriate prophylaxis (as defined by CDC guideline (5)) compared with rate of this infection in patients who receive appropriate prophylaxis, expressed as a ratio was found to be 3.43. Table 5 depicts the process measures and outcome measures according to SIGN guidelines. (6)
This study was aimed to evaluate the current prescribing pattern along with rationality, its impact on SSI rate and on hospital stay and number of extra drugs needed. Previous study from Pakistan (12) reported 55.7% males lower compared to ours 64%, mean age of the patients was 35 [+ or -] 17 years, and somewhat less compared to our study, i.e., 38.8%.
In our study SSI rate was 8.64% which was similar to previous studies. (13) In our study E. coli was most commonly isolated pathogen, followed by S. aureus which is in accordance with previous Indian study. (19) SSI rate for two most commonly performed surgeries herniorrhaphy and appendectomy is comparable to an earlier study carried out in India (14) and a worldwide meta analysis study. (20) There is no significant difference in SSI rate between genders, this finding is similar to a previous study reported in Iran in 2006. (21) SSI rate increases with age above 40 years, which was statistically significant at p < 0.0001 and was similar to study reported from India. (22) SSI rate among patients receiving general anesthesia in our study was 16.67% as compared to other modes (7.92%), which is in accordance with previous study done in UK. (23) SSI rate was higher in emergency surgery than in elective and is comparable to another Indian study. (14) In our study SSI rate was significantly higher in diabetic and hypertensive patients which was also seen in a previous Indian study. (22) In our study there was no difference in SSI rate between laproscopic and open surgery. A study by Jawien et al. (15) reported less SSI rate in laproscopic surgery than in open surgery. SSI led to significantly extended hospital stay (9.98 days) which is similar to a European study (1998)24 which reported 9.8 days.
In our study a single pre-operative dose of antimicrobial therapy was given before the operative procedure which is in accordance with the various standard guidelines and previous studies also showed that single dose prophylaxis is not associated with increased rate of SSI when compared to multiple dose regimens. (25) In our study mean duration of preoperative intravenous therapy was 0.75 [+ or -] 0.45 days, followed by mean post-operative intravenous therapy for 3.33 [+ or -] 2.24 and post-op oral therapy for 4.58 [+ or -] 3.34 days. However timing of administration of first dose of antimicrobial pre-operatively was in compliance with the CDC guidelines. (5) Mean duration of post-operative antimicrobial use was 7.88 days which is longer than reported by previous study from India, i.e., 5 days (16) which may be due to differences in prevalent practices. All patients received antimicrobials, in both the pre-operative and post-operative period, and no antimicrobial was given in the intra-operative period. Most commonly used drug group for prophylaxis was third generation cephalosporins, followed by metronidazole, and penicillin group similar to an Indian study. (17) In our study none of the patients received cefazolin as recommended by various guidelines. (5-8)
For surgical prophylaxis it is important to select an antimicrobial with narrowest antibacterial spectrum to reduce the emergence of resistance, secondly the antimicrobial antibiotic must be active against the most likely contaminating microorganisms for that type of surgery, the first-generation cephalosporins are excellent agents for skin and soft tissue infections owing to Streptococcus pyogenes and methicillinsusceptible S. aureus. Hence a single dose of cefazolin just before surgery is the preferred prophylaxis for procedures in which skin flora are the likely pathogens. For patients undergoing clean operative procedure for herniorrhaphy, a clean procedure a single dose of cefazolin 1 g preoperatively and for appendectomy, a clean contaminated surgery single preoperative intravenous dose of either cefotetan or cefoxitin 1 g is recommended. (5-8) Therefore, it is recommended that the use of third generation cephalosporins such as ceftriaxone and cefotaxime be avoided in surgical prophylaxis as it may be required later if patient develops serious sepsis For herniorrhaphy use of cefazolin is appropriate, while in case of appendectomy third generation cephalosporins have been used as substitute for cefotetan and cefoxitin in our study as in India cefazolin is available while cefotetan and cefoxitin are not marketed. (26) However this is not justified, as third generation cephalosporins have to be spared for therapeutic purpose. Better option would be an alternative like cefuroxime. Dirty and contaminated surgeries required broad spectrum antimicrobials coverage. Drugs like piperacillin, tazobactum, linezolid were used mainly after diagnosis of SSI for therapeutic purpose.
In our study 52% patients received inappropriate chemoprophylaxis according to Kunin's criteria. (11) This finding is in accordance with earlier studies that showed 51.5% (11) and 65.6% (27) respectively. Most of the antimicrobials were broad spectrum, prescribed for longer duration which was unwarranted. Inappropriate prophylaxis was associated with higher culture positive (SSI positive) rates (13.04%) as compared to the appropriate prophylaxis (3.8%).
To our knowledge this study is first of its kind in India. Strength of this study was the assessment of rationality of chemoprophylaxis based on Kunin's criteria (11) and SIGN guideline (6) as well as comparison of SSI rate in patients receiving appropriate and inappropriate chemoprophylaxis. One of the limitations of our study is cross-sectional design of the study. Also there was no patient follow up after discharge up to 30 days which is required according to CDC definition of SSI and hence some cases of SSI after discharge from hospital may be missed. Patient post-discharge questionnaire was not used and further analysis based on quality of life could be done. Further studies with larger sample size can be planned including additional cost borne by the patient because of inappropriateness. In depth sub analysis into various types of surgeries and various drug regimens and infections can be done to select a proper and rational regimen for an individual surgery using other guidelines. Kunin's criteria (11) is a preliminary evaluation of appropriateness, a further in-depth analysis of antimicrobial prescription can be done according to the Modified Kunin's criteria, (25) Giessen score, (28) and by SWABs score. (29) Evaluation based on the combined scores from both the surgical wound judgment and prescription analysis can also be done.
Inappropriate chemoprophylaxis as evident in this study is associated with higher SSI rate leading to prolongation of hospital stay and increased number of drugs usage. Adoption of international standard and formulation of locally feasible guidelines can help overcome this situation. However this is a single center study and results of this study may not be generalized.
Received 4 August 2012
Accepted 6 September 2012
Available online 1 January 2013
Conflict of interest
The authors have no conflict of interest to declare.
The authors would like to express their thanks to Dr. Pankaj R. Patel, Dean, Smt. NHL Medical College and Dr. M.H. Makwana, Superintendent, V.S. Hospital for permitting them to do this work in V.S. Hospital. The authors also express gratitude to surgery department for support.
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Devang Ashwinkumar Rana *, Supriya Deepak Malhotra, Varsha Jitendra Patel
Department of Pharmacology, Smt. N.H.L Muni, Medical college, Ahmedabad, Gujarat, India
* Corresponding author. Tel.: +91 9426418842/079 27622834.
E-mail addresses: email@example.com (D.A. Rana), firstname.lastname@example.org (S.D. Malhotra), email@example.com (V.J. Patel).
Table 1--Kunin's criteria (11) for rationality assessment of antimicrobial prescriptions. Category I: Agree with the use of antimicrobial therapy/prophylaxis, the program is appropriate Category II: Agree with the use of antimicrobial therapy/prophylaxis, but a potentially fatal bacterial infection cannot be ruled out or prophylaxis is probably appropriate, advantages derived remain controversial Category III: Agree with the use of antimicrobial therapy/prophylaxis, but a different (usually less expensive or toxic) antimicrobial is preferred Category IV: Agree with the use of antimicrobial therapy/prophylaxis, but a modified dose is recommended Category V: Disagree with the use of antimicrobial therapy/prophylaxis, administration is preferred Category VI: data cannot be judged because of missing information Table 2--Distribution of surgeries according to class (18) and surgical site infection (SSI) (2) rate. Operative SSI positive Class procedures % patients % Clean (I) 104 47.27 2 1.92 Clean contaminated (II) 53 24.09 4 7.54 Contaminated (III) 39 17.72 3 7.69 Dirty (IV) 24 10.91 10 41.66 Total 220 100 19 8.64 Table 3--Surgical site infection (SSI) rates (2) and variables. SSI negative SSI positive (n = 201) (n = 19) Mean age 37.71 [+ or -] 13.44 51.26 [+ or -] 16.21 [greater than or equal to] 40 years 134 6 >40 years 67 13 Gender Male 131 10 Female 70 9 Days of hospital stay 7.81 [+ or -] 4.1 17.79 [+ or -] 6.41 [less than or equal 118 1 to] 7 days >7 days 83 18 No. of drugs given 7.43 [+ or -] 1.74 11 [+ or -] 2 Type of anesthesia General 15 3 Other SA and LA 186 16 Mode of operation Elective 184 13 Emergency 17 6 Open 188 19 Laproscopic 13 0 Co-morbid conditions (b) Diabetes mellitus 2 9 Hypertension 10 5 Total (n = 220) p value (a) Mean age 38.88 [+ or -] 14.19 <0.0001 [greater than or equal to] 40 years 140 0.0047 >40 years 80 Gender Male 141 0.32 Female 79 Days of hospital stay 8.67 [+ or -] 5.17 <0.0001 [less than or equal 119 to] 7 days >7 days 101 No. of drugs given 10.42 [+ or -] 3.37 <0.0001 Type of anesthesia General 18 0.193 Other SA and LA 202 Mode of operation Elective 197 0.0073 Emergency 23 Open 207 0.60 Laproscopic 13 Co-morbid conditions (b) Diabetes mellitus 11 <0.0001 Hypertension 15 0.0048 Using Fischer's exact two tailed test and unpaired t-test. (a) p < 0.005. (b) Four patients presented with both diabetes and hypertension. Table 4--Appropriateness of surgical prophylaxis based on Kunin's criteria11 and surgical site infection rate (n = 220). Appropriate therapy SSI SSI Category I Category II Subtotal positive negative 2(0.91%) 103(46.81%) 105(47.72%) 4 101 Inappropriate therapy Category III Category Category V 108(49.09%) IV 0(0%) 7(3.19%) Inappropriate therapy SSI SSI Subtotal positive negative 115(52.28%) 15 100 Fishers exact test, p = 0.0165, significant. Table 5--Core indicators for surgical audit based on SIGN guidelines. (6) (a)Process measures 1 Was prophylaxis given for an operation No local guideline included in local guidelines? available 2 If prophylaxis was given for an Justification was operation not included in local not recorded in the guidelines, was a clinical justification case note for prophylaxis recorded in the case notes? 3 Was the first dosage of prophylaxis Yes given within 30 min of the start of surgery? 4 Were the choice, dosage and route of Consistent without administration consistent with local guideline guidelines for that procedure? 5 Was the prescription written in the Not applicable "once-only" section of the drug prescription chart? 6 Was the duration of prophylaxis greater Yes then 24h? (b)Outcome measures 1 Surgical site infection rate = number of 19/220 = 0.0864 SSIs occurring postoperatively/total (8.64%) number of operative procedures 2 Rate of SSIs occurring postoperatively 13.04/3.8 = 3.43 in patients who receive inappropriate prophylaxis (as defined in guideline) compared with rate of this infection in patients who receive appropriate prophylaxis, expressed as a ratio 3 Rate of Clostridium difficile infections No culture recorded occurring postoperatively in patients Clostridium who receive inappropriate prophylaxis difficile infection (as defined in guideline) compared with rate of this infection in patients who receive appropriate prophylaxis, expressed as a ratio
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|Title Annotation:||Original article|
|Author:||Rana, Devang Ashwinkumar; Malhotra, Supriya Deepak; Patel, Varsha Jitendra|
|Publication:||The Brazilian Journal of Infectious Diseases|
|Date:||Jan 1, 2013|
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