|Year : 2018 | Volume
| Issue : 1 | Page : 13-18
Adherence to surgical antibiotic prophylaxis guidelines in an Indian tertiary care hospital
Namita Jaggi, Pushpa Nirwan, Meenakshi Chakraborty
Department of Infection Control, Artemis Hospitals, Gurgaon, Haryana, India
|Date of Web Publication||6-Aug-2018|
Dr. Namita Jaggi
Artemis Hospitals, Sector 51, Gurgaon - 122 001, Haryana
Source of Support: None, Conflict of Interest: None
Introduction: The surgical antibiotic prophylaxis guidelines are developed to provide surgeons with a standardised approach to the rational, safe and effective use of antimicrobial agents for the prevention of surgical-site infections based on international, national and local recommendations. However, despite the availability of these guidelines, the adherence to the set protocols is a challenge. This study was carried out to evaluate the adherence to presurgical antibiotic prophylaxis in a tertiary care hospital.
Materials and Methods: The antibiotic audit was prospectively carried out for 29 months January 2014—May 2016 for randomly selected clean and clean-contaminated surgeries. Measurable parameters for each selected case were choice of antibiotic, timing of administration and duration. The results were statistically analysed (Minitab 17.0 software).
Results: A total of 1549 surgeries were audited. Out of this, 1501 (96.9%) surgeries fulfilled the inclusion criteria and 76.8% were clean. Mean age of the patients was 42.9 ± 18 years with the majority being females 52.5%. The most commonly used antibiotics were amikacin 32.5%, cefuroxime 29.5% and cefazolin 22.9%. The three parameters tested for adherence showed individual compliance of 87.3% for appropriate selection of antibiotic, 85.3% for appropriate administration and 34.9% for appropriate duration of antibiotic, respectively. Overall adherence to presurgical antibiotic prophylaxis guidelines by the surgeons showed significant results (69.2%, P < 0.05).
Conclusion: The present study highlights the adherence and challenges faced in transforming hospital-specific guidelines into practice. The adherence to SAP protocols by surgeons was found comparable with that of the developed countries. This is due to their involvement in the formulation of antibiotic guidelines.
Keywords: Antibiotic usage, surgical antimicrobial prophylaxis compliance audit, Surgeons' adherence to surgical antimicrobial prophylaxis, surgical antibiotic prophylaxis
|How to cite this article:|
Jaggi N, Nirwan P, Chakraborty M. Adherence to surgical antibiotic prophylaxis guidelines in an Indian tertiary care hospital. J Patient Saf Infect Control 2018;6:13-8
|How to cite this URL:|
Jaggi N, Nirwan P, Chakraborty M. Adherence to surgical antibiotic prophylaxis guidelines in an Indian tertiary care hospital. J Patient Saf Infect Control [serial online] 2018 [cited 2019 Oct 18];6:13-8. Available from: http://www.jpsiconline.com/text.asp?2018/6/1/13/238598
| Introduction|| |
Surgical site infections (SSIs) are the second most frequent cause of healthcare-associated infections (HAIs) and are mainly responsible for the post-operative illness leading to increased morbidity and mortality. Recently updated guidelines define an SSI as an infection that occurs at or near a surgical incision within 30 days of the procedure or within 90 days if an implant is left in place.,
In developed countries, SSIs contribute to 14%—16% of the estimated 2-million HAIs reporting the SSI rate of 1.9%. They occur in 2%—5% of patients after clean extraabdominal operations and in up to 20% of patients undergoing intraabdominal procedures. However, in developing nations like India, the SSI rate ranges from 1.7% to 8.3% (Mean-4.2%). SSIs are associated with substantial economic costs. In India, where an estimated 72% of healthcare expense is out-of-pocket, the additional cost associated with SSI (e.g. additional treatment and loss of ability to work) represents a potentially significant burden to patients and their families.
About one-third of the SSI could be prevented by taking appropriate infection control measures in the pre-, intra- and post-operative period. Surgical antimicrobial prophylaxis (SAP) which is an initial administration of short course of an antimicrobial agent before surgery is a proven effective measure in the pre-operative period. SAP is critical in preventing infections that may lead to sepsis, organ failure and death during hospital stay.
Surgical care improvement project has identified three primary SAP performance measures: Appropriate antibiotic selection, administration of antibiotics within 1 h of incision (exceptions are vancomycin and fluoroquinolones) and discontinuation of prophylactic antibiotics within 24 h of surgery end time. Bratzler et al. in 2005 reported baseline results from the national surgical infection prevention campaign indicating that surgeon's selection of an appropriate antibiotic was correct in 92.6% of cases. However, only 55.7% of patients the SAP was administered within 1 h before incision and in 40.7% patients it was discontinued within 24 h of surgery. In India, not much data are available on the pattern of use of prophylactic antibiotics. Judicious and appropriate use of presurgical antibiotic prophylaxis would not only contribute to the prevention of SSI but would also prevent the antimicrobial resistance by avoiding the unnecessary and incorrect administration of antibiotics sometimes beyond 24 h. There is a need to generate baseline data on the pattern of use of prophylactic antibiotics as regards to Inappropriate choice, time of administration, duration of use and dosage of antibiotic and the present study aims at measuring surgeons compliance to all the three parameters.
| Materials and Methods|| |
The present study was carried out prospectively from January 2014 to May 2016 in a 380 bedded tertiary care private healthcare setting.
The study included the randomly selected clean and clean-contaminated surgeries that were audited based on the hospital guidelines. Patient details such as demographics (patient gender, age, allergy to antibiotic and history of chronic illness) and course of treatment were obtained from electronic hospital information system.
Contaminated and dirty surgeries were excluded as they involve antibiotic administration as part of their treatment regimen. Patients with confirmed microbiological testing indicative of infections were also excluded from the study.
An uninfected operative wound in which no inflammation is encountered and the respiratory, alimentary, genital or uninfected urinary tracts are not entered. In addition, clean wounds are primarily closed and if necessary drained with closed drainage. Operative incisional wounds that follow non-penetrating (blunt) trauma should be included in this category if they meet the criteria.
Operative wounds in which the respiratory, alimentary, genital or urinary tracts are entered under controlled conditions and without unusual contamination. Specifically, operations involving the biliary tract, appendix, vagina and oropharynx are included in this category, provided no evidence of infection or major break in technique is encountered.
Hospital surgical antimicrobial prophylaxis guidelines
SAP guidelines were prepared and released by the hospital antibiotic stewardship committee wherein the inputs from surgeons were obtained and incorporated in the policy. The hospital SAP guidelines briefly recommended the following criteria:
Important points for surgical antimicrobial prophylaxis administration
- The prophylactic agent chosen should have activity against the most common surgical wound pathogens
- Prophylaxis is unnecessary if the patient is already receiving antibiotics that cover the likely pathogens
- Patients receiving therapeutic antimicrobials for a remote infection before surgery to ensure adequate serum and tissue levels of antimicrobials with activity against likely pathogens for the duration of the operation
- Intravenous administration is ideal because it produces reliable and predictable serum and tissue concentrations
- Administration of first dose of antimicrobial should be done within 60 min before surgical incision
- Vancomycin and fluoroquinolones should be administered 120 min before surgery as they require prolonged infusion times
- In caesarean sections, the antimicrobials should be administered pre-incision or after cord clamping. This should be done as close to the incision as practically possible
- Antimicrobial-specific pharmacokinetic and pharmacodynamic properties and patient factors must be considered when selecting a dose
- Dosing is based on the patient's actual body weight. If the patient's actual weight is more than 20% above ideal body weight (IBW), the dosing weight (DW) can be determined using the formula DW = IBW + 0.4 (actual weight — IBW)
- Intraoperative re-dosing is needed if the duration of the procedure exceeds 2 half-lives of the drug or if there is excessive blood loss during the procedure (i.e., >1500 ml)
- Post-operative antimicrobial administration is not necessary for most procedures. Duration of antimicrobial prophylaxis should be <24 h (within 48 h for cardiothoracic surgery) for surgical procedures.
Surgical antimicrobial prophylaxis adherence audit tool
The SAP audit tool was designed to incorporate all required details of the selected case such as demographic details of the patient, surgery type (Start time and end time), ASA score, surgeons' name, anaesthesiologist, pre-surgical antibiotic used, time of administration, post-surgical antibiotic used and antibiotic stopped after 24 h (72 h in cardiac cases) of surgery SAP audit was carried out by the clinical pharmacists in the hospital using this tool.
Parameters assessed for each selected surgical case were choice of antibiotic, time of administration and duration for which antibiotic was used.
Statistical method used
The Kolmogorov—Smirnov test was performed to assess normality. The continuous data have been reported as mean ± standard deviation. Parametric data were analysed with student's t-test/Z-test. Non-parametric data were analysed with the Mann—Whitney U-test. Categorical data were compared using Pearsons Chi-square test. The statistical analysis of data was performed using Ms-Excel and Minitab (version 17.0) software (Minitab, Inc.).
| Results|| |
A total of 1549 surgeries have been selected, out of which 1501 (96.9%) fulfilled the inclusion criteria. The remaining 48 cases were excluded because of inappropriate type of surgeries (contaminated and dirty). The demographic details showed that majority of patients were females (52.5%) with mean age of 42.9 ± 18 years [Table 1]. Majority of the surgeries selected were clean (76.8%). There were 11 categories of surgeries evaluated for compliance to SAP guidelines. They included ortho implants, coronary artery bypass grafting (CABG), lap cholecystectomy, lower segment caesarean section, neurosurgery, urosurgery, organ transplant, general surgeries, orthosurgeries, gynae surgeries and other surgeries [Figure 1].
The overall rate of compliance of the selected surgeries with the hospital SAP guidelines was reported as 69.2% (3115 cases) whereas the remaining 30.5% cases (1372) did not comply. The difference in compliance rate for clean and clean-contaminated surgeries was not statistically significant (87% vs. 78%, P = 0.34). Moreover, 13% of clean procedures and 22% of clean-contaminated procedures were found non-compliant. The surgeons' adherence to the SAP guidelines reported a significant difference in compliance rate between different surgical specialities (P = 0.001). The maximum compliance was reported in gynaecological, CABG, organ transplant and neurosurgeries as 97.3%, 95.6%, 95.2% and 90.0%, respectively. The lowest adherence was observed in urological procedures (76.4%) [Table 2].
|Table 2: Surgeons' adherence to surgical antimicrobial prophylaxis guidelines for various surgical groups|
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The antibiotics used for the surgeries were also analysed separately [Figure 2]. The most commonly used antibiotics were amikacin 32.5%, cefuroxime 29.5% and cefazolin 22.9%. The rest were augmentin (8.6%), ceftriaxone (2.9%), cefoperazone/sulbactam (2.2%), piperacillin/tazobactam (0.05%) and some less frequently (<1%) used antibiotics such as ciprofloxacin, cefepime/sulbactam, metronidazole, cefoperazone/sulbactam/ethylenediaminetetraacetic acid (EDTA), piperacillin and tazobactam. Out of these, the use of amikacin, cefuroxime and cefazolin reported 85.8%, 88.7% and 69.8% adherence to the policy, respectively. Antibiotics used less frequently (cefepime/sulbactam, metronidazole, cefoperazone/sulbactam/EDTA, piperacillin, tazobactam and piperacillin/tazobactam) are not recommended for pre-surgical prophylaxis as per the policy guidelines. There was non-statistical difference between the overall compliance of antibiotics with respect to the guidelines (P = 0.21) [Table 3].
|Figure 2: Proportion of antibiotics used as surgical antimicrobial prophylaxis|
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|Table 3: Association between different antibiotics and their adherence to surgical antimicrobial prophylaxis guidelines|
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The three parameters tested for adherence showed individual compliance of 87.3% for appropriate selection of antibiotic, 85.3% for appropriate administration and 34.9% for appropriate duration of antibiotic, respectively. There were 0.35% (16 cases) surgeries which did not require SAP as per the guidelines. The reasons for non-compliance were wrong selection of antibiotic in 191 cases (12.7%), wrong time and dosage of antibiotic in 207 cases (13.8%) and prolonged antibiotic usage in 974 cases (64.9%) [Table 2].
| Discussion|| |
Based on the best available evidences to optimise the patient care and surgeon's practice, the American Society of Health System Pharmacists (ASHP) has developed therapeutic guidelines on antimicrobial prophylaxis in surgery. The effectiveness of preoperative prophylaxis in preventing SSIs is well established.
In India, though the formulation and dissemination of SAP guidelines is effective, there are gaps in the practices. Despite the knowledge and availability of guidelines, surgeons show lack of adherence. The present study evaluates the standard of care delivered by surgeons as analysed by their adherence to hospital SAP guidelines. We have observed a wide range of compliance (70.2% to 97.3%) in various surgical specialities as given in [Table 2]. Similar studies conducted in various countries have reported the range as 4.9%—70.7%.
In the present study, the compliance rate for clean surgeries (87%) and the clean-contaminated (78%) ones have not shown any significant difference. It shows that the surgeons' follow the standard practice guidelines for surgeries to a great extent in our hospital. The decision to use prophylaxis depends on the cost of treatment and morbidity associated with infection, compared with the cost and morbidity associated with using prophylaxis. In contrast, a similar study conducted by Abdel-Aziz et al. in Qatar have reported 54.5% and 45.5% adherence in clean and clean-contaminated surgeries, respectively.
Cephalosporins are recommended for most surgical procedures because they are active against the common skin pathogens Staphylococcus aureus and Streptococcal species. Although for some gynaecologic surgeries, antibiotic combinations are recommended. In the present study, the most commonly used prophylactic antibiotic was amikacin (33%), followed by cefuroxime (29%) and cefazolin (23%). Their compliance to hospital SAP guidelines was also reported as 85.8%, 88.7% and 69.8%, respectively. Studies from other developing countries reported the use of cefazolin relatively higher than cefuroxime (44.6% vs. 17.8%) with the compliance rate being 53.3% and 72.2%, respectively with respect to guidelines. In contrast, Chandrasekaran et al. reported cefuroxime as a preferred antibiotic over cefazolin for clean wounds (68.4% vs. 14.6%). Use of cefazolin in combination with gentamicin has also been observed in 32.1% cases in a study by Rafati et al. The high rate of infection also shows the need of updating combination drugs such as β-lactam inhibitor combinations in surgical prophylaxis.
The prophylactic regimen in patients undergoing surgery should include an agent effective against the most likely infecting organisms, but need not eradicate every potential pathogen. The choice of antibiotic should be based on the local antibiogram. In the present study, 12.7% surgeries reported inappropriate antibiotic selection which was relatively lesser than reported from other studies 31.5%. A review article including 18 studies from various parts of the world reported inappropriate choice of antibiotic in a wide range-5%—78%. Another Indian study reported 19.05% and 33.96% adherence to right choice of antibiotic in clean and clean-contaminated wounds, respectively.
The goal of antibiotic prophylaxis before surgery is to ensure effective serum and tissue levels of the drug for the duration of the surgery. It is evident that the optimal time of administration of prophylactic antibiotic is within 1 h of surgery. A meta-analysis of randomised controlled trials showed that antibiotic administration just before or at the time of anaesthesia resulted in significantly lower infection rates in patients undergoing spinal surgery. Our study reported that in 85.3% cases the prophylactic antibiotic was administered on time (within 1 h before incision). Comparable results were obtained from studies conducted by Tourmousoglou et al. in Greece (100%), Meeks et al., in United States (79%) and Bull et al., in Australia (76.4%). However, other Indian studies have reported relatively lower adherence as 9.52%—7.55% and 13%, respectively.
In our study, it was found that prolonged antibiotic usage contributed significantly 64.9% to the non-adherence to SAP guidelines. The current guidelines recommend that prophylactic antibiotic should end within 24 h (48 h in cardiothoracic surgery) of surgery completion. Longer courses of antibiotics are falsely believed to be a good preventive measure against SSIs. However, there is no documented benefit of antibiotics after wound closure in the reduction of SSI.,, Extended prophylaxis is potentially harmful due to the development of drug-toxicity, super-infections and bacterial resistance., Post-operative antibiotics are being administered for a mean duration of 5 days as per an Indian study and 6.4 days in a Taiwanian study. Other similar studies have shown variable results regarding prolonged antibiotic usage-(8.6%) France, (18%) the United States, (32.9%) Germany, (63.7%) Greece, (80%) Malaysia and (94.2%) Iran.
| Conclusion|| |
The present study highlights the adherence and challenges faced in transforming hospital-specific guidelines into practice. The adherence to the SAP protocols by surgeons in our hospital was comparable with that of the developed countries. This is due to their involvement in the formulation of antibiotic guidelines. However, we have also observed some gaps in discontinuing antibiotics after surgery. These may be addressed by increasing sensitisation of the surgeons to judiciously use antibiotics as preoperative prophylaxis. It is because they not only make the treatment more expensive but also contribute to selection of resistant organisms and harmful side effects. Hence, the surgeons involved should observe the essential principles of asepsis and antisepsis along with practicing adherence to the SAP guidelines-right drug, right dose, right time and right duration.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3]