Analysis of antibiotic usage for surgical prophylaxis in a tertiary care hospital in Bangalore, Karnataka, India

Analysis of antibiotic usage for surgical prophylaxis in a tertiary care hospital in Bangalore, Karnataka, India Shashikala N.1, Manasa S.2*, Vikram HCV.3 DOI: https://doi.org/10.17511/jopm.2020.i04.08 1 Shashikala N., Infection Control Department, Sagar Hospital Banashankari, Bangalore, Karnataka, India. 2* Manasa S., Infection Control Department, Sagar Hospital Banashankari, Bangalore, Karnataka, India. 3 Venkatesh Vikram H.C., Medical Director, Sagar Hospital Banashankari, Bangalore, Karnataka, India.


Introduction
Prophylaxis is indicated for all procedures not classified as clean. As previously qualified, certain risk factors justify the use of prophylaxis for clean procedures as well. The following recommendations are provided for specific procedures. A recent quality standards report that further qualifies the strength of recommendations based on the quality of available supporting evidence is also useful.

Results
The medical charts were reviewed for demographic (age, sex) data, clinical data of patients were also collected.
Our records search showed that the mean age of the patients who underwent surgeries was 39 years and that 56% were females and 44% were males.
In the surgeries audited, cardiac was 38%, gastrointestinal surgeries were 26%, orthopedic and neurological cases were 10% each, and urology and OBG surgeries were 8% each. Out of 100 surgeries that were audited only 4% were clean, 84% were clean-contaminated, 4% were contaminated and 8% were dirty.
The present study had more number of cleancontaminated surgeries than the clean in our hospital.

Fig-2: Surgical wound classification as per the CDC.
In the 100 cases, pre-surgical prophylaxis was given for 92% of cases and in 8% of cases, it was not followed.
The three parameters tested for adherence showed individual compliance of 92% for appropriate selection of antibiotics, 85% for the appropriate administration, and 56% for the appropriate duration of antibiotics respectively.
Most of the surgeries the antibiotic was initiated at induction accounting to 41% of the total surgeries.
Out of 100 post-surgical case files, two antibiotics were most commonly used as pre-surgical prophylaxis accounting to 48%, closely followed by one antibiotic accounting to 44%. Pre-surgical prophylaxis was not used for 8% cases.  During the audit, it was observed that only 56% of Consultant surgeons have adhered to hospital antibiotic policy.

Discussion
The best timing for the surgical antimicrobial administration is based on a theoretical principle: the peak of antibiotic concentration at the surgical site should be reached at the time of incision. Thus, the timing depends on the pharmacokinetics of each antibiotic.
Guidelines provide divergent duration comprised between 30 and 60 min before incision. The administration of vancomycin and fluoroquinolones should be a starter within 120 minutes before surgical incision due to the prolonged infusion times required for these drugs [20].
However, the relation between the timing of the surgical antimicrobial prophylaxis and the incidence of surgical site infection remains unclear.
In a randomized clinical trial, Weber et al. administered 1.5 g of cefuroxime early (30-75 min before scheduled incision) in the anesthesia room or late in the operating room (0-30 min before scheduled incision) to 5,580 patients who were followed for a 30-day duration [21].
The antibiotic was given 42 min before incision in the early group and 16 min before incision in the late group. The rate of surgical site infection was 5.1%. It did not significantly differ in the early group and the late group. This finding was confirmed in each population: surgical division, wound class, immunosuppressive drugs, body mass index, diabetes, and age. This randomized clinical trial is pragmatic, clear, and well-conducted. An impressive number of patients Were included. The result, which does not support the "old theoretical model of pharmacokinetics?, is confirmed in each subgroup of patients, even those considered at high risk for surgical site infection.
This study is a model for future studies: its pragmatic design makes it possible to clearly respond to a critical clinical question.
One of the limitations is probably the follow-up duration that was limited to 30 days, while surgical site infection in patients with prosthetic material should have been observed for 1 year. Can it really be believed that this limitation would change the main finding? Another limitation is that surgical antimicrobial prophylaxis represents one step of a series of measures aiming at preventing surgical site infection.
The WHO guidelines include 9 preoperative recommendations, 13 preoperative and/or intraoperative measures, and 3 postoperative measures 18. Thus, one can suggest that it would be surprising that a few minutes in the administration of antibiotics play a major role in terms of outcome.
In the present study, due to its design and the research constraints, the practices were probably optimal in the two groups.
In addition, the definition and surveillance of surgical site infections are not as consensual as they can first appear [22,23]. Finally, the authors tested the use of cefuroxime as surgical antimicrobial prophylaxis. The current study does not provide observations related to the results which could have been similar to other antibiotics.
In an observational study, the same group of authors suggested that the infection risk enhanced when surgical antimicrobial prophylaxis was administrated in the last 30 minutes before incision compared with a 31-60 minutes interval [24].
Another observational study concluded, at variance, that risk of surgical site infection was reduced when antimicrobial prophylaxis was infused in the last 30 minutes before incision [25]. Using an unadjusted model, a large study including 32,459 patients found higher rates of surgical site infection for timing more than 60 min prior to incision.
When the model was adjusted for patient, procedure, and antibiotic variables, no association was identified between antibiotic timing and surgical site infection [26]. In conclusion, a large scale randomized clinical trial and a well-conducted observational study showed that timing, if the deviation remains reasonable, i.e., between 30 and 60 min, is not critical for the prevention of surgical site infection. However, once again, in those studies, no major Deviation, as prolonged delay or administration after surgical incision, was reported. He current study agrees with this pragmatic conclusion. The study results do not allow deviating from current WHO guidelines, which suggested randomized controlled trials to clarify the optimal timing of surgical antimicrobial prophylaxis.
However, the research agenda around the prevention of surgical site infection still require future investigations. In the intensive care unit, a continuous infusion of beta-lactams, after an initial bolus, is used to optimize the efficiency of antimicrobial treatments.
The time above the minimal inhibitory concentration of the causative pathogen is a critical determinant for its clearance. A meta-analysis showed a positive effect on the outcome of patients [27].
If this strategy was transferred to the operating room, at least for high-risk procedures, it would partly resolve the issue related to the timing of surgical antimicrobial prophylaxis administration.
Elsewhere, the long-term ecological effect of the surgical antimicrobial prophylaxis was never clearly assessed, which is a major bias in the era of increasing antimicrobial resistance.
The study of Weber et al. raises two comments. The first comment is the relevance of control quality studies. The timing between surgical antimicrobial prophylaxis and incision has been used as a surrogate for guideline adherence [28,29].
Depending on the study, a timing different from either 30 or 60 min was considered as an optimal practice. In a Dutch survey, the timing of the first dose was not in compliance with guidelines in 50% Of cases [30], which can be penalizing in some circumstances. In addition, in routine practice, the timing between surgical antimicrobial prophylaxis and surgical incision appears difficult to control for all the operating room team. The present results raise questions about the interest of such quality criteria.
This suggests that audit should preferentially focus on end-points that were confirmed in randomized clinical trials. The second comment is the value of randomized clinical trials.
The theoretical translation of concepts at the bedside did not often result in clinical success. Observational studies include inherent bias that makes their findings uncertain. International, national, and institutional organizations should support the use of randomized clinical trials in an attempt to improve the practices.
In conclusion, Weber et al. show that the timing of surgical antimicrobial prophylaxis does not affect the incidence of surgical site infection if its administration occurs in a reasonable range. One should keep in mind that surgical antimicrobial prophylaxis is a single element of a large bundle for the prevention of surgical site infection. This study also shows that randomized clinical trials remain mandatory in an attempt to confirm (or not) theoretical concepts.
The effectiveness of preoperative antibiotic prophylaxis is well established. Despite this, surveys have shown that optimal practice isn't achieved in many hospitals [31].
In the present study, the majority (92%) of patients received antibiotic prophylaxis prior to surgery. This figure is comparable to those reported in previous studies from Turkey, Israel, and Greece. Among the study participants, 58% received antimicrobial combinations [32][33].
Potentially harmful aspects of such inappropriate antibiotic combinations include the emergence of resistant bacteria, super-infection, the risks of toxic and allergic reactions, and increased cost of therapy.

Conclusion
Surgical antimicrobial prophylaxis is the most common indication for antimicrobial use in hospitals.
However, it is associated with high rates of inappropriate use Effective use of antimicrobials to prevent infection is essential to reduce risks associated with surgical procedures.