Original Article

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Compliance with Surgical Antibiotic Prophylaxis Guidelines in Pediatric Surgery Idan Carmeli3

Elad Feigin2,3

Enrique Freud2,3

1 Department of Neonatology, Schneider Children’s Medical Center of

Israel, Petah Tikva, Israel 2 Sackler Medical School, Tel Aviv University, Tel Aviv, Israel 3 Department of Pediatric Surgery, Schneider Children’s Medical Center of Israel, Petah Tikva, Israel 4 Department of Infectious Diseases, Schneider Children’s Medical Center of Israel, Petah Tikva, Israel

Ran Steinberg2,3

Itzhak Levy2,4

Address for correspondence Gil Klinger, MD, Department of Neonatology, Schneider Children’s Medical Center of Israel, 14 Kaplan St Petah Tikva 49202, Israel (e-mail: [email protected]).

Eur J Pediatr Surg 2015;25:199–202.

Abstract

Keywords

► antibiotic prophylaxis ► surgical site infection ► pediatric surgery

Introduction Surgical antibiotic prophylaxis (AP) guidelines balance the need to prevent infection with the risks of adverse drug effects. Our aim was to assess compliance with AP guidelines. Methods A retrospective study was performed in a pediatric medical center. Included were patients aged 0 to 18 years that underwent clean-contaminated surgery during a 1-year period (2008–2009) and required AP. Compliance with four AP bundle guidelines was evaluated. Risk factors for noncompliance were identified using univariate and multivariate analyses. Results AP was given to 239 of 247 (96.8%) of patients. Complete compliance with AP guidelines was achieved in 16 of 247 (6.5%) patients. Compliance with guidelines for appropriate antibiotic, drug dose, correct timing, and treatment duration were found in 97.1, 52.2, 31.9, and 35.9% of patients, respectively. Multivariable analysis showed that inappropriate timing was associated with age  4 years (p ¼ 0.002), urgent surgery (p ¼ 0.0018), surgical department AP administration (p ¼ 0.0001), and night-time surgery (p ¼ 0.015). Incorrect AP dose was associated with presence of comorbidities (p ¼ 0.006). No risk factor was related to incorrect AP duration. Conclusions We have found a low rate of full compliance with AP guidelines. AP should only be given in the operating room. Increased awareness to AP guidelines is needed.

Introduction Surgical site infections (SSIs) are an important cause of postoperative morbidity and mortality. These infections are the third most common hospital acquired infection with a postoperative infection rate as high as 27%.1 Measures to prevent SSIs include an operating room environment that ensures aseptic conditions, adequate patient preparation, aseptic technique, and the use of antibiotic prophylaxis (AP) before and during surgery.1–4

received August 21, 2013 accepted after revision December 4, 2013 published online March 28, 2014

Prophylactic antibiotic guidelines have been formulated, balancing the need to prevent infection with the risks of adverse side effects. Proper utilization of these guidelines has the potential to decrease surgical infection-related costs, hospital length of stay, overall antibiotic use, and the risk of emergence of antibiotic resistant bacteria. The guidelines include the type of operation that requires AP and the type, dosage, duration, and timing of antibiotic treatment. However, several reports have demonstrated that the guidelines have not been fully implemented and

© 2015 Georg Thieme Verlag KG Stuttgart · New York

DOI http://dx.doi.org/ 10.1055/s-0034-1368798. ISSN 0939-7248.

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Gil Klinger1,2

Antibiotic Prophylaxis in Pediatric Surgery

Klinger et al.

that nonoptimal compliance leading to overuse, underuse, and misuse of antibiotics is common.5–9 The overall compliance rate with surgical AP guidelines is based on limited data and ranged between 12 and 28% in adult and pediatric populations.5–9 The objectives of this study were to identify the adherence rates to AP guidelines and to identify possible factors for noncompliance with these guidelines.

Patients and Methods A retrospective study evaluating compliance with surgical AP guidelines was conducted at Schneider Children’s Medical Center of Israel, which is the largest university affiliated pediatric tertiary care center in Israel. The study was performed during a 1-year period (2008–2009). The study cohort included all patients between the ages of 0 and 18 years, who underwent “clean-contaminated” gastrointestinal surgery, requiring AP according to the Center for Disease Control (CDC) guidelines.2 “Clean-contaminated” surgery includes controlled surgery entry to the gastrointestinal, respiratory or genitourinary tracts without significant spillage. Excluded were the following patients: preterm infants, nongastrointestinal surgery, patients who had surgery meeting the definition of “clean,” “contaminated,” or “dirty” surgery as defined by the CDC,2 patients that received antibiotics during the day before surgery or immunocompromised patients. Patients with perforated appendices did not meet inclusion criteria as they were not “clean-contaminated” surgery and required prolonged antibiotic treatment. Data were extracted from the surgical department medical records and included the following: demographic data (age, gender), clinical data (weight, medical problems, surgical diagnoses, type and urgency of surgery), and data related to AP (antibiotic type, drug dose, exact time when antibiotics were given, surgery duration, additional doses given and the time when they were given, duration of antibiotic treatment, length of hospital stay, occurrence of infection, pathology results, name of surgeon). The study was approved by the Institutional Research Ethics Board.

Statistical Analysis The AP-related data of each subject was assessed and compared with each specific AP guideline of the Israeli Ministry of Health4 and of the CDC2 and it was determined whether or not the guideline was met. The bundle of AP guidelines assessed was: use of appropriate antibiotic, correct initial timing of AP (aimed to achieve therapeutic drug level at time of incision), correct drug dose, and correct treatment duration. To identify risk factors for AP noncompliance, we examined the relationship between patient variables and the compliance with each specific AP guideline. Statistical analysis used JMP software (SAS Inc., North Carolina, United States). Univariate analysis was performed using Fisher exact test or Chi-square test, as required. Variables with a p value < 0.1 on univariate analysis and additional variable that the surgical and infectious disease European Journal of Pediatric Surgery

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teams thought likely to influence compliance were entered into a stepwise logistic regression model.

Results During the study period, 380 charts were reviewed for inclusion in the study. A total of 133 children were excluded for the following reasons: “dirty” operation (97), antibiotic treatment before surgery (25), operation not requiring AP (7), immune compromise (2), and incomplete data (2). The remaining 247 children met the inclusion criteria and were included in the study. The characteristics of the study cohort are shown in ►Table 1. The mean age of the cohort was 8.7 ( 5.4) years, 58.7% were males and 82.2% had urgent surgery. The most common surgical procedures performed were appendectomy (173), pyloromyotomy (16), stoma closure (13), and intussusception reduction (10). AP was given to 239 of 247 patients (96.8%). Fulfillment of AP guideline requirements is presented in ►Fig. 1. Only 16 of the 247 children (6.5%) met all requirements. A high rate of adherence to the guidelines was achieved regarding correct antibiotic use (97.1%), however, correct drug dose was given in only 52.2% of patients and the recommended timing and duration of treatment were achieved in only a minority of patients (31.9 and 35.0%, respectively). Of the 160 patients that did not receive AP on time, 61 children received AP 1 to 2 hours before surgical incision, 14 children within 2 hours after surgical incision, 47 children 2 to 4 hours after incision, 38 children more than 4 hours after incision, and for 4 children the timing

Table 1 Pediatric surgical patient characteristics Characteristic

Pediatric surgical patients (n ¼ 247)

Mean age (y) (range)

8.7 (0–18)

Age < 4 y (%)

63 (25.5)

Male gender (n) (%)

145 (58.7)

Type of surgery Urgent surgery (n) (%)

203 (82.2)

Elective surgery (n) (%)

44 (17.8)

American Surgical Association class 1

120

2

35

3

13

Unknown Comorbidities (n) (%)

79 70 (28.3)

Place of antibiotic prophylaxis administration Surgical department (n) (%)

70 (28.4)

Operating room (n) (%)

161 (65.2)

Unknown (n) (%)

8 (3.2)

No antibiotic prophylaxis (n) (%)

8 (3.2)

Abbreviation: y, year.

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Fig. 1 Fulfillment of surgical antibiotic prophylaxis guidelines. Adherence to each antibiotic guideline and to the combination of all guidelines is presented.

was unknown. Although, only 77 of 239 (32.2%) patients were treated for the duration specified in the AP guidelines, in 19 of 239 (7.9%) additional patients, the treatment was extended appropriately as infection was suspected or proven. Multivariable analysis was performed to identify risk factors for nonadherence to the three AP guidelines with low implementation. Risk factors included in the analyses were age  4 years, urgent surgery, presence of comorbidities, place where AP was given (surgical department vs. operating room), and night-time surgery. Incorrect timing of AP was associated with age  4 years (p ¼ 0.002), urgent surgery (p ¼ 0.0018), surgical department AP administration (p ¼ 0.0001), and night-time surgery (p ¼ 0.015) and was not associated with presence of comorbidities (p ¼ 0.36). No risk factor was found to be related to incorrect AP duration. Incorrect AP dose was related only to presence of comorbidities (p ¼ 0.006) and was not associated with age  4 years (p ¼ 0.75), urgent surgery (p ¼ 0.48), or night-time surgery (p ¼ 0.08).

Discussion The present study assessed compliance with AP guidelines in a pediatric surgical cohort. We identified an overall rate of 6.5% of adherence to the AP guideline bundle. Use of correct antibiotic for AP was achieved in almost the entire cohort, however correct drug dose was given in about half the patients and correct AP timing and treatment duration were achieved in less than a third of patients. Risk factors related to nonadherence to guidelines were age  4 years, surgical department AP administration, presence of comorbidities, and night-time surgery; however risk factors varied depending on the specific guideline examined.

Klinger et al.

The overall compliance with AP guidelines in our pediatric cohort was low. It is of note that noncompliance is not identical with insufficient AP as many patients received more antibiotics than required. Previous reports on compliance with AP guidelines in the pediatric population have similarly shown low rates of full compliance ranging between 12 and 76%.5–9 The most common reason in our study that contributed to the low compliance rate was noncompliance with the AP duration guideline. This is in concordance with previous reports.5–9 Use of appropriate antibiotic therapy was achieved in 97.1% of patients. The high compliance to this AP guideline is above the 57 to 92% reported compliance range.5–9 Correct timing of AP was achieved in only 31.9% of patients compared with the range reported in the medical literature ranging between 50 and 70%.5,7–9 The suboptimal compliance rate in the present study was probably related to the practice of giving AP in the surgical department. Surgical department AP administration resulted in most patients in a greater than recommended time interval between AP and surgical incision. When we examined the rate of correct timing of AP in patients receiving AP in the operating room, we found the rate of correct timing increased to 54%, thus AP should be given in the operating room and not in the surgical department. It is unlikely that inappropriate timing was influenced by nursing management as timing of dose was related either to the time when the AP order was written (if given in the surgical department) or to the time when administered by the anesthetist in the operating room. Appropriate drug dosing was given to 52.2% of our cohort. This is somewhat lower than the reported range of 72 to 92%.5–9 The definition of inappropriate drug dosing varied between studies. We used a relatively strict definition allowing for up to a 10% difference between recommended and actual dose. Use of a strict definition contributes to a lower compliance rate. Others have used definitions allowing for up to a 20% difference between actual and recommended dose. Improving compliance with the AP drug dosing guideline may be achieved by use of computerized systems that automatically display the recommended dose range and check for accuracy of prescribed dose.10 Recommended treatment duration was achieved in only 32.2% of patients. Previous reports regarding this guideline have similarly shown a relatively low compliance rate of 36 to 40%.5–9 As in our study, the main reason for noncompliance was an increased duration of treatment. In the present study, a justified increase in treatment duration was found in a minority of patients, however for the majority of patients, no identifiable cause was found. It is likely that the main reason for noncompliance with this guideline is the surgeons wish to err on the side of caution, however the result of this is greater exposure of pediatric patients to antibiotics and an increased risk of developing resistant bacteria. Risk factors for noncompliance with AP guidelines were different for each guideline. Multiple risk factors were related to not giving AP on time however the most important of these was giving AP in the surgical department. Incorrect AP dose was related only to presence of comorbidities which possibly European Journal of Pediatric Surgery

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Antibiotic Prophylaxis in Pediatric Surgery

Antibiotic Prophylaxis in Pediatric Surgery

Klinger et al.

required correction of dose in some instances. We did not identify risk factors for incorrect AP duration and speculate that this was in large related to surgeons preference of giving antibiotics for a longer duration. Improving overall compliance with AP guidelines may be achieved using identified risk factors. However, the compliance goal should be to achieve a persistent high compliance rate. An electronic surveillance system is a good tool to ensure long-term compliance with guidelines.11

3

4

5

Conclusions 6

We have found a low rate of compliance with AP guidelines. Increased compliance may be achieved by giving AP only in the operating room, use of computerized systems for drug dosing, and better education regarding the risks associated with prolonged antibiotic treatment.

7

8

Conflict of Interest None. 9

References

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1 American Society of Health-System Pharmacists. ASHP Therapeu-

tic Guidelines on Antimicrobial Prophylaxis in Surgery. Am J Health Syst Pharm 1999;56(18):1839–1888 2 Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR; Centers for Disease Control and Prevention (CDC) Hospital Infection Control Practices Advisory Committee. Guideline for Prevention

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of Surgical Site Infection, 1999. Am J Infect Control 1999;27(2): 97–132, quiz 133–134, discussion 96 Alexander JW, Solomkin JS, Edwards MJ. Updated recommendations for control of surgical site infections. Ann Surg 2011;253(6): 1082–1093 Israel Ministry of Health. Guidelines for prevention of infection in operating rooms. Available at: http://www.health.gov.il/hozer/ mr24_2001.pdf. Accessed May 21, 2013 van Kasteren ME, Kullberg BJ, de Boer AS, Mintjes-de Groot J, Gyssens IC. Adherence to local hospital guidelines for surgical antimicrobial prophylaxis: a multicentre audit in Dutch hospitals. J Antimicrob Chemother 2003;51(6):1389–1396 Vaisbrud V, Raveh D, Schlesinger Y, Yinnon AM. Surveillance of antimicrobial prophylaxis for surgical procedures. Infect Control Hosp Epidemiol 1999;20(9):610–613 Hing WC, Yeoh TT, Yeoh SF, Lin RT, Li SC. An evaluation of antimicrobial prophylaxis in paediatric surgery and its financial implication. J Clin Pharm Ther 2005;30(4):371–381 Górecki W, Grochowska E, Krysta M, Wojciechowski P, Taczanowska A, Stanek B. A prospective comparison of antibiotic usage in pediatric surgical patients: the safety, advantage, and effectiveness of the Surgical Infection Society guidelines versus a common practice. J Pediatr Surg 2002;37(10):1430–1434 Groselj Grenc M, Derganc M, Trsinar B, Cizman M. Antibiotic prophylaxis for surgical procedures on children. J Chemother 2006;18(1):38–42 Radley DC, Wasserman MR, Olsho LE, Shoemaker SJ, Spranca MD, Bradshaw B. Reduction in medication errors in hospitals due to adoption of computerized provider order entry systems. J Am Med Inform Assoc 2013;20(3):470–476 Voit SB, Todd JK, Nelson B, Nyquist AC. Electronic surveillance system for monitoring surgical antimicrobial prophylaxis. Pediatrics 2005;116(6):1317–1322

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Compliance with surgical antibiotic prophylaxis guidelines in pediatric surgery.

Surgical antibiotic prophylaxis (AP) guidelines balance the need to prevent infection with the risks of adverse drug effects. Our aim was to assess co...
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