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Drug Utilization Evaluation of Antimicrobials used in Surgery Department in a Tertiary Care Hospital

Philip Jacob, Arul Balasubramanian*, Kothai Ramalingam

Department of Pharmacy Practice, Vinayaka Mission’s College of Pharmacy, Vinayaka Mission’s Research Foundation (Deemed to be University)

Salem – 636008, Tamil Nadu, India.

* Corresponding Author Name: Dr. ArulBalasubbramanian

Email: [email protected] Contact: +91-9944117022

ABSTRACT

Drug Use Evaluation (DUE) or Drug Utilization Evaluation is the management of continuous, precise, criteria-based assessments of the use of drugs, which will warrant that the drugs are being used relevantly, which is at the discretion of the patient. The aim of the study is to determine the drug utilization evaluation of Antimicrobials used in the surgery department at a tertiary care hospital; to assess the culture sensitivity with various antimicrobials and identify the most effective antimicrobial against the organism isolated. A prospective observational study was used for the assessment. A sample size of 181 patients who had undergone the respective surgeries and antimicrobial treatment were selected for this study.

On analyzing the study sample receiving antimicrobials, it was found that 84.53% of the population in pre-operative and 35.35% in post-operative conditions received only antibiotics. 15.46% and 64.65 % received a combination of antibiotic and anti-protozoal as pre-operative and post-operative medications respectively.

Analyzing the use of antibiotics on the sample reveals that the majority of patients received Cephalosporins both in pre and post-operative conditions as 70.78% and 82.32%

respectively. In the study of isolation of organisms, it was found that 67.46% were Gram – ve and 27.71% Gram + ve organisms. But it was also found that 4.81% were Gram +ve and Gram –ve organisms.

Keywords: Drug Utilization Evaluation; Antimicrobials; Surgery; Culture sensitivity Test.

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INTRODUCTION

Drug Use Evaluation (DUE) or Drug Utilization Evaluation is the management of continuous, precise, criteria-based assessments of the use of drugs, which will warrant that the drugs are being used relevantly, which is at the extent of the patient (1). Drug use evaluation is a necessary element of the drug use quality refinement procedure. It is an execution enhancement technique to optimize patient outcomes (2). The DUE studies have a promising impact both locally and internationally as they are relentlessly used as an indicator of the healthcare system. Prescribing patterns frequently utilize techniques to assess the agreement of doctors who prescribe according to standard treatment guidelines as well as rational prescribing practices(3–5). Inappropriate use of the drug can also result in a hike in medical cost, development of antimicrobial resistance, ADR, and mortality of patients.

Therefore, drug utilization (DUE) studies become one of the impending tools in the assessment of the health program(6,7).

Antimicrobials are agents which are used to eradicate or edge the growth of microorganisms. These microbials are accountable for the root cause of infectious diseases.

The main mechanisms for the devastation of microbes by the antimicrobials are the effect of drug molecules on the cell structure, the effect of metabolic steps which are not usually found in the host body, or the attraction of microbes to the biomolecules(8). Antibiotics are the agents obtained from one of the microorganisms and these agents are confirmed in their efficacy on other microorganisms at a fixed-dose. Depending on the activity of the microbes, they are classified as bacteriostatic and bactericidal. In surgery, the uses of antibiotics are to treat the established infections and also thwart infections post-surgery (9).

An increase in the rate of morbidity and mortality can be barred with the help of judicious use of antibiotics. At the same time, one of the prime factors for the increase of antibiotic resistance isthe overuse and underuse of antibiotics. In India, negligence of treatment guidelines and dearth of information regarding the proper use of medications are some other reasons behind the increase of antimicrobial resistance (10). Various studies have reported that there are deficient treatment plans especially in the selection of molecules, setting of frequency, and duration in the prophylactic antibiotic treatment. (11).

Administration ofantibiotics in patients on surgical procedures are:

● To reduce the occurrence of surgical site infection

● Precise application of antibiotics to warrant the effectiveness

● Safeguard the normal flora of the patient in the use of antibiotics.

● Avert the change of host’s defense mechanism

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● Minimize the possible adverse effects of antibiotics (9).

It has been found that surgical site infections are complications in post-operative departments, which play an important role in nosocomial infections. Several studies revealed that this type of infection is the second most nosocomial infection. In the US, it has been found that one-quarter of 2 million hospital-acquired infections annually (12).

To avoid postoperative complications, the use of antibiotics is inevitable (13). The importance of antimicrobial sensitivity checking are:

● To check the efficacy of given antibiotics against the isolated organisms

● To reduce the overuse of antibiotics

● To ensure optimization in the selection of antibiotics

● To verify the trends in the change of antibiotic therapy (14).

Most commonly, empirical therapy is effective over some microbes because they show no resistance to the pathogens (15).

The study aims to determine the drug utilization evaluation of Antimicrobials used in the surgery department at tertiary care hospital. This study also aims to assess the culture sensitivity with various antimicrobials and to identify the most effective antimicrobial against the organism isolated.

METHODOLOGY

A prospective observational study was conducted at the general surgery ward for six months. For this study, 181 patients were considered based on the inclusion and exclusion criteria. All the patients, who had undergone the respective surgeries and undergone antimicrobial treatment were included and selected for this study. Patients were included with their consent or willingness to participate in the study. Patients, who discontinued their treatment and expressed their non-willingness to participate in the study, were excluded.

All subjects were provided with a brief introduction regarding the study and confidentiality of the data. A written informed consent printed in their understandable language was obtained from the patient or caregiver. Relevant information was collected according to the approved pre-designed data collection form. Data of each subject was individually screened to assess the drug utilization pattern of antimicrobials used in both pre- operative and post-operative periods. The culture and sensitivity reports were also collected to identify the most effective antimicrobial against the isolated organism. The data was then statistically analyzed.

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The data collected was entered as well as analyzed using Microsoft Excel (2010 version) and the results are presented below in tabular form as absolute numbers and percentages supplemented with graphs for easy interpretation.

RESULTS

The study result showed that 50.27% of the patients are male and 49.72% are femaleand it was found that 8.83% of the surgeries performed on patients within the age group of fewer than 20 years, followed by 13.8% in the age group of 20-40 years, 32.59% in the age group of 41-60 years, 40.88% in the age group of 61-80 years and 3.86% in the age group 80 years and above.

In the study, on analyzing the type of surgeries undergone, it is noted that the most common surgery was incision and drainage with a percentage of 23.2%, followed by hernioplasty 15.46%, Fistulectomy 9.39%, Appendectomy 8.28%, Haemorrhoidectomy 8.28%, Breast Lump Excision 8.28%, slough excision 7.73%, Cholecystectomy 7.18%, Thyroidectomy 6.07%, Circumcision 4.41% and Lipoma excision 1.65%. The distribution of patients based on the surgical procedure is shown in Table 1.

On analyzing the study sample receiving antimicrobials, it was found that 84.53% of the population in pre-operative and 35.35% in post-operative conditions received only antibiotics. 15.46% and 64.65 % received a combination of antibiotic and anti-protozoal as pre-operative and post-operative medications respectively. None of the patients received any anti-fungal and anti-viral medications.The type of antimicrobials used in pre-operative and post-operative conditions is shown inTable 2.

Analyzing the use of antibiotics in pre-operative sample reveals that 70.7% of the patients received only Cephalosporins, 8.2% received Penicillins, 0.55% received Fluoroquinolones, 3.31% received both Cephalosporins and Penicillin, 1.65% received a combination of Cephalosporins and Fluoroquinolones, and none of the patients received Sulphonamides, Aminoglycosides, macrolides, and tetracyclines.The type of antibiotics used in pre-operative conditions is shown in Table 3.

On analyzing the pre-operative use of Cephalosporins on the sample it is found that 71.53% of the patients had been administered with a combination of Cefoperazone and Sulbactam, followed by 12.40% with Ceftriaxone, 8.75% with Cefpirome, and 7.30% with a combination of Ceftriaxone and Tazobactum.The cephalosporin used under pre-operative conditions is shown in Table 4.

On analyzing the use of Cephalosporins in each surgical procedure, it was found that in Appendectomy, out of 15 surgical cases, 8 received a combination of Cefoperazoneand

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Sulbactam, 2 received Ceftriaxone, 1 received cefpirome, and 2 received a combination of Ceftriaxone and Tazobactum. In Breast Lump Excision, out of 15 surgical cases 11 received a combination of Cefoperazoneand Sulbactam, 2 received Ceftriaxone, 2 received cefpirome and none of the patients received a combination of Ceftriaxone and Tazobactum. In Cholecystectomy out of 13 surgical cases 4 received a combination of Cefoperazoneand Sulbactam, 1 received Ceftriaxone, 1 received cefpirome, and 3 received a combination of Ceftriaxone and Tazobactum.

In Circumcision out of 8 surgical cases, 2 received a combination of Cefoperazoneand Sulbactam, 1 received Ceftriaxone, none of the patients received cefpirome and 1 received a combination of Ceftriaxone and Tazobactum.In Fistulectomy out of 17 surgical cases, 10 received a combination of Cefoperazoneand Sulbactam, 1 received Ceftriaxone, 2 received Cefpirome and 1 received a combination of Ceftriaxone and Tazobactum.

In Haemorrhoidectomy out of 15 surgical cases, 5 received a combination of Cefoperazoneand Sulbactam, 2 received Ceftriaxone, 1 received cefpirome and none of the patients received a combination of Ceftriaxone and Tazobactum.In Hernioplasty out of 28 surgical cases, 16 received a combination of Cefoperazoneand Sulbactam, 3 received Ceftriaxone, 1 received cefpirome and 1 received a combination of Ceftriaxone and Tazobactum

In Incision & Drainage, out of 42 surgical cases; 30 received a combination of Cefoperazoneand Sulbactam, 2 received Ceftriaxone, 2 received cefpirome and none of the patients received the combination of Ceftriaxone and Tazobactum.In Lipoma excision, out of 3 surgical cases; 1 received a combination of Cefoperazoneand Sulbactam, 1 received Ceftriaxone, 1 received cefpirome and none of the patients received a combination of Ceftriaxone and Tazobactum.

In Thyroidectomy, out of 11 surgical cases; 5 received a combination of Cefoperazoneand Sulbactam, 2 received Ceftriaxone, 1 received Cefpirome and 1 received a combination of Ceftriaxone and Tazobactum.In Slough Excision, out of 14 surgical cases; 6 received a combination of Cefoperazoneand Sulbactam, none of the patients received Ceftriaxone, none of the patients received cefpirome and 2 received a combination of Ceftriaxone and Tazobactum.

In the assessment of the study sample receiving the antimicrobials after surgery, it was found that 64.65% of patients received a combination of antibiotics with Antiprotozoal and 35.35% received only antibiotics. On the usage of antibiotics, it was found that 82.32%

received Cephalosporins only, followed by 6.62% receiving Penicillins, 3.31%

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Cephalosporins and Fluoroquinolones, 2.76% Fluoroquinolones, 1.65% Oxazolidinone, 1.65% Tetracyclines, 1.10% Fluoroquinolones, and Oxazolidinone, 0.55% Carbapenems and none of the patients received sulphonamides, aminoglycosides, and macrolides.The type of antibiotics used in post-operative conditions is shown in Table 3.

On analyzing the sample receiving Cephalosporins post-operatively, it was found that 51.93% of the sample have been treated with a combination of Cefoperazone and Sulbactam, followed by 25.41% with Ceftriaxone, 6.07% with Cefpirome, and 2.20% Cefuroxime.The cephalosporin used under post-operative conditions is shown in Table 4.

On analyzing the use of Cephalosporins in post-operative surgery, it was found that, in Appendectomy, out of 15 surgical cases, 8 received a combination of Cefoperazoneand Sulbactam, 5 received Ceftriaxone, 1 received cefpirome and none of the patients received Cefuroxime.In Breast Lump Excision, out of 15 surgical cases; 8 received a combination of Cefoperazoneand Sulbactam, 3 received Ceftriaxone, 2 received cefpirome,and 1 received Cefuroxime.

In Cholecystectomy out of 13 surgical cases, 4 received a combination of Cefoperazone +Sulbactam, 4 received Ceftriaxone, 1 received cefpirome,and 1 received Cefuroxime. In Circumcision out of 8 surgical cases, 2 received a combination of Cefoperazoneand Sulbactam, 4 received Ceftriaxone, none of the patients received cefpirome and none of the patients received cefuroxime.In Fistulectomy out of 17 surgical cases, 10 received a combination of Cefoperazoneand Sulbactam, 4 received Ceftriaxone, 1 received cefpirome and none of the patients received Cefuroxime.

In Haemorrhoidectomy out of 15 surgical cases; 5 received a combination of Cefoperazoneand Sulbactam, 5 received Ceftriaxone, 1 received cefpirome,and 1 received Cefuroxime.In Hernioplasty out of 28 surgical cases; 16 received a combination of Cefoperazoneand Sulbactam, 6 received Ceftriaxone, 1 received cefpirome and none of the patients received Cefuroxime.

In Incision & Drainage, out of 42 surgical cases; 28 received a combination of Cefoperazoneand Sulbactam, 8 received Ceftriaxone, 2 received cefpirome and none of the patients received Cefuroxime.In Lipoma excision, out of 3 surgical cases; 1 received a combination of Cefoperazoneand Sulbactam, none of the patients received Ceftriaxone, 1 received cefpirome and none of the patients received Cefuroxime.

In Thyroidectomy, out of 11 surgical cases; 6 received a combination of Cefoperazoneand Sulbactam, 3 received Ceftriaxone, 1 received cefpirome and none of the patients received Cefuroxime.In Slough Excision, out of 14 surgical cases; 6 received a

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combination of Cefoperazoneand Sulbactam, 4 received Ceftriaxone, none of the patients received cefpirome,and 1 received Cefuroxime.

The study sample was assessed with a Culture and Sensitivity test and it was found that 64.08% of the patients performed the test, but 35.91% did not perform the culture and sensitivity test.The results of the culture and sensitivity study show that in 65.51% of the cases wound swab specimens were used, followed by 29.31% where pus and 5.17% where blood was used as a specimen.In the study of isolation of organisms, it is found that 67.46%

were Gram – ve and 27.71% Gram + ve organisms. However, it was also found that 4.81%

wereGram +ve and Gram –ve organisms.

In this study, different strains of organisms were isolated from a patient's specimen for culture. 28.44% of the test had no growth when the culture test was performed. Among the isolated organisms 20.68% were Staphylococcus aureus, 18.96% were E. coli, 6.89%

Streptococcus pneumonia, 6.03% were Klebsiella spp, 5.17% were Pseudomonas spp, 4.31%

were Proteus mirabilis, 3.44% were Candida Species, 2.58% were Monrgrenella morganii, 1.72% were Monrgrenella morganii and E. coli and S. aureus.

Antibiotic susceptibility showed that most of the E.coli strains are sensitive to the combination of Cefoperazone and Sulbactam, followed by ceftriaxone. Streptococcus aureus was found sensitive to a combination of Piperacillin and Tazobactum followed by Cefoperazone and Sulbactam. Candida species are sensitive to Linezolid. Klebsiella spp was found sensitive to Cefoperazone and Sulbactam and ceftriaxone. Proteus mirabilis was found sensitive to ceftriaxone and cefpirome. Streptococcus pneumonia was found sensitive to Piperacillin and Tazobactum, followed by a combination of Cefoperazone and Sulbactam and Ceftriaxone.

DISCUSSION

The study was conducted to evaluate the drug use pattern of antimicrobials used in pre-operative and post-operative patients admitted in the general surgery department at Tertiary care hospital, Pathanamthitta District, Kerala. This study also aims for the assessment of culture and sensitivity with several antimicrobials and to identify the most effective antimicrobial agent against the isolated organisms.

Age-wise distribution was analyzed and found that most of the patients who underwent surgeries were in the age group of 61-80 years followed by 41-60 years which agrees with the common concept of the need for surgery is related to age, chronic illness, worsening of body function, which is the same in many countries. The study was conducted by assessing the case reports of 181 patients, which revealed that the study population was

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predominantly male (50.27%) while females made (49.72%) of the sample studied. This can be attributed to the fact that in Kerala, the educational status of the patients in the state plays a key role in utilizing the facilities related to health care.

In this study, it was arrived at that the most commonly performed surgical procedure was Incision &Drainage (23.2%) followed by Hernioplasty (15.46%). Further, it was found that pre-operative prophylaxis was mostly done with the use of antibiotics (84.53%) or a combination of antibiotic and anti-protozoal medications (15.46%). Almost all patients received antibiotics intravenously. None of the antifungal or antiviral drugs were used for prophylaxis. All antimicrobials started one day before the surgery.Also found in the study was that the most commonly prescribed antimicrobial agent was Cephalosporins (70.7%).

Among cephalosporins, the most predominantly used antibiotic was a combination of Cefoperazone and Sulbactam(71.53%) followed by Ceftriaxone (12.40%). Our study correlates with the study conducted by Aiswarya et al. ((16,17)

As per the WHO 2016 guidelines, the use of antimicrobials in post-operative surgery is not recommended unless there is an active infection. Extended use of antibiotics may lead to an increased hospital stay, which inturn may lead to an increase in the cost of treatment and most importantly increased antimicrobial resistance. In this study, one of the objectives was to assess the use of antimicrobials in post-operative surgery in the study sample.

In this study, it was found that 64.65% of the patients received a combination of antibiotic and antiprotozoal agents. Among these, the most frequently used antibiotic was Cephalosporins (82.32%). On analyzing the use of Cephalosporins in post-operative surgery, it was found that 51.93% of the patients were been treated with a combination of Cefoperazone and Sulbactam, followed by ceftriaxone (25.41%).

Observing the use of Antimicrobial sensitivity is very crucial to provide the treatment effectively and also reduces the spread of resistance of the microorganisms. In this study, an effort had been made to assess the surgical site microorganism responsible for infection and sensitivity to the antimicrobials(18).

In this study, a culture and sensitivity test was performed in 64.08% of specimens and in 35.91% it was not done. Out of 116 collected specimens for culture and sensitivity testing, 76 samples were wound swabs and 34 were pus specimens. Out of 83 culture-positive tests, 67.46% were Gram-negative organisms were 27.71% gram-positive and 4.81% were both gram-positive and gram-negative organisms.

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A large percentage of the microorganism isolated was Staphylococcus aureus (20.68%) followed by E. coli (18.96%). This study gives an insight into the microbial pattern isolated from post-operative patients in the tertiary care hospital.

Out of 83 culture-positive cases, 79 showed the growth of a single organism while only 4 cases unveiled the growth of more than one species. Single organisms were shown rather than multiple growths.

The drug of choice according to culture and sensitivity plays an important role. The precision of the selection of an antibiotic is very important in their effective therapy. Failure in the selection shows resistance to the particular pathogen. In this study,S. aureus was most sensitive to the combination of Piperacillin and Tazobactum (9 cases) followed by a combination of cefoperazone and Sulbactam (8 cases). E. coli was more sensitive to a combination of cefoperazone and Sulbactam (8 cases) followed by ceftriaxone (5 cases).

On antimicrobial susceptibility testing, Cefoperazone and Sulbactam were found to be the most effective drug due to the sensitivity of the majority of the isolated organism. The next most effective antibiotics were a combination of Piperacillin and Tazobactum followed by ceftriaxone.

CONCLUSION

The precision of prescribing is determined by the accessibility, safety, effectiveness, value range of sensitivity, specific site action, tiniest resistance, and hypersensitivity to the patient population. Drug utilization review of antimicrobials is an important tool among health care professionals to identify the effective use of antibiotics. This study concludes that, in pre-operative patients, antibiotics were administered most commonly as a prophylaxis treatment. It was followed by a combination of Antibiotics and Anti-protozoal agents. These agents were administered intravenously.

Post-operative patients were mostly administered with a combination of antibiotics and anti-protozoal agents than with antibiotics alone. The most widely used antibiotics were third-generation cephalosporins, that is, Cefperazone- Sulbactam combination and ceftriaxone and Penicillins, a combination of Piperacillin and tazobactam. The most frequently used antiprotozoal drug was Metronidazole.

The majority of the sample underwent culture and sensitivity test, where wound swab was the most commonly used specimen and mostly isolated organisms were gram-negative organisms. Among gram-negative organisms, S. aureus was the most abundantly isolated organism followed by E. coli. Cefoperazone and Sulbactam combination was the most effective drug because the majority of the organisms were sensitive to these drug

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combinations.Resistance wasobserved with Chloramphenicol and ofloxacin. The continuous assessment of prescription patterns of antibiotics is important to enhance the decision of the prescribers to be most beneficial for the patients. By evaluating the prescribing pattern continuously, health providers can improve the effectiveness of the treatment, thus resulting in improved patient contentment by fulfilling the positive therapeutic outcome.

REFERENCES

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clinical pharmacology. Elsevier; 2012. p. 383–94.

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6. Kothai R, Manivannan E, Arul B, Sabu S, Shajinimol N, John SM. Drug usage pattern of analgesics among intraoperative patients in a tertiary care hospital. Int J Res Pharm Sci. 2018;9(4):1077–80.

7. Shalini S, Ravichandran V, Saraswathi R, Mohanty BK, Dhanaraj SK. Drug Utilization Studies – An Overview. Int J Pharm Sci Nanotechnol [Internet]. 2010 May

31;3(1 SE-Review Articles). Available from:

https://www.ijpsnonline.com/index.php/ijpsn/article/view/470

8. Tripathi KD. Essentials of Medical Pharmacology. 7th ed. New Delhi: Jaypee Brothers Medical Publishers (P) Ltd; 2013. 816–835 p.

9. Sane RM, Shahani SR, Kalyanshetti AA. Antibiotic Prescription Pattern in Surgical Wards of MGM Hospital, Kamothe. Int J Infect [Internet]. 2018;5(1):e57914.

Available from: https://sites.kowsarpub.com/iji/articles/57914.html

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10. Sharma P, Goel D. Utilization Assessment of antimicrobial prophylaxis in surgical patients at tertiary care teaching hospital. Saudi J Heal Sci. 2018 Apr 1;7(1):23–7.

11. Khan A K A, P V M, Rashed MR, Banu G. A Study on the Usage Pattern of Antimicrobial Agents for the Prevention of Surgical Site Infections (SSIs) in a Tertiary Care Teaching Hospital. J Clin Diagn Res [Internet]. 2013/02/27. 2013 Apr;7(4):671–

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14. Jorgensen JH, Ferraro MJ. Antimicrobial susceptibility testing: a review of general principles and contemporary practices. Clin Infect Dis an Off Publ Infect Dis Soc Am. 2009 Dec;49(11):1749–55.

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Table 1: Distribution of Patients based on surgical procedures

Type of surgery Frequency (n=181) Percentage (%)

Appendectomy 15 8.28

Breast Lump Excision 15 8.28

Cholecystectomy 13 7.18

Circumcision 8 4.41

Fistulectomy 17 9.39

Haemorrhoidectomy 15 8.28

Hernioplasty 28 15.46

Incision & Drainage 42 23.2

Lipoma excision 3 1.65

Thyroidectomy 11 6.07

Slough Excision 14 7.73

Table 2: Assessment of the type of Antimicrobial used in pre and postoperative conditions

Type of Antimicrobial used

Pre-operative Post-operative Frequency

(n=181)

Percentage Frequency (n=181)

Percentage

Antibiotics 153 84.53 64 35.35

Antibiotic & Anti- protozoal

28 15.46 117 64.65

Anti-fungal - - - -

Anti-viral - - - -

Table 3: Assessment of Pre and Post-operative use of Antibiotics Antibiotics Pre-operative Post-operative

Frequency (n=181)

Percentage Frequency (n=181)

Percentage

Carbapenems - - 1 0.55

Cephalosporins 128 70.7 149 82.32

Fluoroquinolones 1 0.55 5 2.76

Oxazolidinone -0 - 3 1.65

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Penicillins 15 8.2 12 6.62

Tetracyclines 0 0 3 1.65

Cephalosporins &Fluoroquinolones 3 1.65 6 3.31

Cephalosporins &Penicillins 6 3.31 - -

Fluoroquinolones+ Oxazolidinone - - 2 1.10

Table 4: Assessment of Pre and post-operative use of Cephalosporins

Antibiotics Pre-operative Post-operative

Frequency (n=181)

Percentage Frequency (n=155)

Percentage

Cefoperazone&Sulbactam 98 71.53 94 51.93

Ceftriaxone 17 12.40 46 25.41

Cefpirome 12 8.75 11 6.07

Ceftriaxone &Tazobactum 10 7.30 - -

Cefuroxime - - 4 2.20

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