Injury, Int. J. Care Injured 46 (2015) 184–188
Contents lists available at ScienceDirect
Injury journal homepage: www.elsevier.com/locate/injury
Evaluating the use of antibiotic prophylaxis during open reduction and internal fixation surgery in patients at low risk of surgical site infection Sheng-Gen Xu a,*, Zhao-Guang Mao a, Bin-Sheng Liu a, Hui-Hua Zhu a, Hui-Lin Pan b,** a b
Department of Orthopedic Surgery, The People’s Hospital of Jiangshan, Jiangshan City, Zhejiang 324100, PR China Department of Anesthesiology and Perioperative Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA
A R T I C L E I N F O
A B S T R A C T
Article history: Accepted 26 July 2014
Background: Widespread overuse and inappropriate use of antibiotics contribute to increasingly antibiotic-resistant pathogens and higher health care costs. It is not clear whether routine antibiotic prophylaxis can reduce the rate of surgical site infection (SSI) in low-risk patients undergoing orthopaedic surgery. We designed a simple scorecard to grade SSI risk factors and determined whether routine antibiotic prophylaxis affects SSI occurrence during open reduction and internal fixation (ORIF) orthopaedic surgeries in trauma patients at low risk of developing SSI. Methods: The SSI risk scorecard (possible total points ranged from 5 to 25) was designed to take into account a patient’s general health status, the primary cause of fractures, surgical site tissue condition or wound class, types of devices implanted, and surgical duration. Patients with a low SSI risk score (8 points) who were undergoing clean ORIF surgery were divided into control (routine antibiotic treatment, cefuroxime) and evaluation (no antibiotic treatment) groups and followed up for 13–17 months after surgery. Results: The infection rate was much higher in patients with high SSI risk scores (9 points) than in patients with low risk scores assigned to the control group (10.7% vs. 2.2%, P < 0.0001). SSI occurred in 11 of 499 patients in the control group and in 13 of 534 patients in the evaluation group during the follow-up period of 13–17 months. The SSI occurrence rate did not differ significantly (2.2% vs. 2.4%, P = 0.97) between the control and evaluation groups. Conclusions: Routine antibiotic prophylaxis does not significantly decrease the rate of SSI in ORIF surgical patients with a low risk score. Implementation of this scoring system could guide the rational use of perioperative antibiotics and ultimately reduce antibiotic resistance, health care costs, and adverse reactions to antibiotics. ß 2014 Elsevier Ltd. All rights reserved.
Keywords: Infection risk factors Prophylactic antibiotics Orthopaedic surgeries Trauma Cefuroxime Ceftriaxone
Introduction Open reduction and internal fixation (ORIF) is a commonly used orthopaedic procedure to treat fractures with excellent outcomes. However, surgical site infection (SSI), a devastating complication associated with orthopaedic implants, can prolong the length of hospital stay and dramatically increase the medical costs [16,20]. To minimise SSI occurrences, perioperative prophylactic antibiotics have been routinely used for all patients undergoing ORIF
* Corresponding author. Tel.: +86 137 5700 5877. ** Corresponding author at: Department of Anesthesiology and Perioperative Medicine, Unit 110, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd., Houston, TX 77030, USA. Tel.: +1 713 563 7467; fax: +1 713 794 4590. E-mail addresses: [email protected] (S.-G. Xu), [email protected] (H.-L. Pan). http://dx.doi.org/10.1016/j.injury.2014.07.026 0020–1383/ß 2014 Elsevier Ltd. All rights reserved.
procedures. Although it is generally accepted that prophylactic antibiotics are effective in reducing the incidence of SSI in contaminated and dirty wounds [3,5], it remains uncertain whether antibiotics should be used routinely with patients undergoing clean ORIF surgeries who are at low risk of developing SSI [13,17]. The evolution of resistant pathogens has developed into a worldwide health crisis. Rampant and unnecessary administration of antibiotics is one of the major contributors to the development of drug-resistant pathogens [28]. To prevent and reduce the spread of microorganisms resistant to treatment, we need to better understand what, when, and how antibiotics should be used [16]. In modern orthopaedic practice, a large number of patients with closed fractures undergo ORIF procedures in ultra-clean ventilated operating rooms. Nevertheless, most physicians routinely use prophylactic antibiotics for patients receiving clean ORIF procedures because of undue fear of SSI. There are some clinical
S.-G. Xu et al. / Injury, Int. J. Care Injured 46 (2015) 184–188
guidelines for the use of prophylactic antibiotics in general surgeries that are designed to reduce the rapid growth of drugresistant organisms [9]. However, there are no evidence-based clinical studies that can provide clear guidelines for the rational use of antibiotics specifically for patients undergoing ORIF surgeries. Also, there is no strong evidence regarding whether prophylactic antibiotics can reduce the occurrence of SSI in orthopaedic patients at low risk of developing infection. Although our understanding of SSI remains incomplete, various types of risk factors, such as the patient’s general health status and the degree of trauma and fractures, can contribute to the development of SSI in orthopaedic patients [18,22,24,32,34]. We reasoned that the major risk factors that predispose a person to SSI could be assessed and graded for patients receiving ORIF surgeries. A simple and easy-to-use scoring method could be applied clinically to guide the rational use of antibiotics in orthopaedic patients at low risk of SSI. Therefore, the objective of our prospective study was to design a simple SSI risk scoring system specifically for ORIF surgeries and determine whether the routine use of prophylactic antibiotics during the perioperative period reduces postoperative SSI in ORIF surgical patients at low risk of infection. We hypothesised that routine perioperative antibiotic treatment does not influence the rate of SSI occurrence in this population of patients. Patients and methods Design of SSI risk factor scorecard We designed a SSI risk factor scorecard (Table 1) by considering five major SSI risk factors associated with ORIF surgeries according to related literature about SSI in surgical patients [15,22,24,25,31,33,34]. Each risk factor was assessed as low (1 point), medium (2 points), or high (5 points). The five risk factors are general health status, primary cause of fracture, surgical site tissue condition/wound class, type of implant, and duration of surgery. Table 1 SSI risk factor scorecard for patients undergoing ORIF surgeries. Risk factor
Classification
Score
General health statusa
Healthy, no known disease Mild systemic disease Severe systemic disease (ASA score >3)
1 2 5
Primary cause of fractureb
Indirect low-energy fracture Direct low-energy fracture Direct high-energy fracture
1 2 5
Intact skin with minor soft tissue damage Minor, superficial skin abrasion Extensive, deep skin and tissue damage
1
Types of implant
Pins and screws only 1 metal plate >2 metal plates
1 2 5
Surgical durationc
4 h
1 2 5
Surgical site tissue condition/wound class
2 5
a Severe systemic disease includes diabetes, cancer, liver or kidney failure, autoimmune disease, acquired immune deficiency syndrome, sepsis, neutrophilic granulocytopenia, peripheral vascular disease, chronic obstructive airway disease, and chronic use of nicotine, alcohol or steroids. b Indirect low-energy fractures refer to fractures distal to the primary site of trauma. Direct high-energy fractures are those caused by, for example, a motor vehicle accident or a fall from high height. c Surgical duration refers to the period from skin incision to skin closure. ASA, American Society of Anesthesiologists.
185
With this scoring system, the lowest total score possible is 5 points, and the highest total score possible is 25 points. If a patient’s SSI risk score reached 9 points, at least one risk factor had been assigned the highest grade or four risk factors had been given a medium grade. Thus, we considered patients with a score of 9 points as having a high risk of developing SSI and patients with a score of 8 points having a low risk. Patient selection and data collection The study was approved by the Institutional Human Subject Ethics Committee (approval #: JY2010-2; approval date: February 1, 2010). This prospective study was conducted in the orthopaedic surgery department from March 2010 through October 2013. Patients aged >8 years of either sex who were scheduled for ORIF procedures and were able to give informed consent were included in the study. Preliminary scoring using the SSI risk factor scorecard was done by an attending surgeon; these scores were subsequently verified by the antibiotic use assessment group in the orthopaedic surgery department. A total of 3415 patients was initially assigned to group A or group B using alternating blocks of 6, and 3256 patients completed the one-year follow-up. For the purpose of this study, only a subgroup of patients at low risk of developing SSI (8 points) from group A and group B was selected for further study. Specifically, those patients with a risk score 8 in group A were then allocated to the evaluation group (no antibiotic treatment, n = 551). Group B patients at low risk were subsequently assigned to the control group (antibiotic treatment, n = 529). For all low-risk patients, the surgical incisions were classified as clean (Class I) according to the wound classification system by American College of Surgeons. All patients in the control group were given an intravenous injection of cefuroxime (0.75 g in normal saline, 3 doses; Esseti Farmaceutici) 30 min before skin incision, 12 h postoperatively, and 24 h postoperatively [6,7]. Patients in the evaluation group were not given any antibiotics during the perioperative period. All patients with a high risk score (9 points) in group A and group B received routine prophylactic cefuroxime treatment, and therefore, were not part of the study. For each patient, surgical duration was initially estimated before surgery on the basis of past clinical experience. If the surgical duration was unexpectedly prolonged, a higher score was then assigned to the patient. Whenever the score reached 9 points, the patient was excluded from the control or evaluation group, and cefuroxime was administered accordingly. SSI surveillance and management All patients were treated with standard ORIF surgical procedures. We used a two-step combination of 2% tincture of iodine and 70% isopropyl alcohol for skin preparations in the operating room. Until time of discharge, each day patients were closely monitored for signs of SSI after surgery (until the sutures were removed), asked whether they had any local pain or discomfort, and had their temperature taken. After discharge, the patients were followed up for at least 13 months for any signs of SSI. The follow-up assessment of SSI was made blind with respect to knowledge of whether antibiotics were received by patients. All cases of SSI were initially diagnosed clinically, which included the classic signs and symptoms of inflammation (progressive swelling, increasing pain, and erythema in the region) and the presence of pus at the surgical site [20]. When SSI was clinically diagnosed, microbiological assessment was performed immediately using samples collected from pus and wound aspirate according to standard protocols (culture, identification and antimicrobial susceptibility). Because SSI associated with ORIF
S.-G. Xu et al. / Injury, Int. J. Care Injured 46 (2015) 184–188
186
Table 2 Distribution of SSI risk scores in patients at low risk of SSI in the control and evaluation groups. Total score
5 6 7 8
Table 4 Fracture locations and distributions of patients at low risk of SSI in the control and evaluation groups.
Number (%) of patients
Anatomic location
Evaluation group (n = 534)
Control group (n = 499)
109 141 150 134
98 132 143 126
(20.41) (26.40) (28.09) (25.09)
Clavicle Phalanx, capitate Both forearm bones Ulna Olecranon Radius Head of radius Shaft of humerus Metatarsus Calcaneum Medial malleolus Lateral malleolus Bimalleolar Trimalleolar Both leg bones Shaft of tibia Patella Shaft of femur Intertrochantic crest of femur Neck of femur
(19.64) (26.45) (28.66) (25.25)
surgeries is a serious complication (and because both Grampositive and Gram-negative organisms may be involved), we used broad-spectrum antibiotics in an effort to control/eliminate SSI quickly. It has been shown that ceftriaxone is effective for treating Staphylococcus aureus infection in orthopaedic patients [14]. Thus, once SSI was diagnosed, the antibiotics (ceftriaxone plus levofloxacin) were administered immediately, and the choice of antibiotics was later adjusted based on the results of bacterial culture and drug sensitivity tests. A patient who did not respond to antibiotic treatment was promptly scheduled for thorough surgical debridement and irrigation, with or without implant removal (depending on whether the implant itself was infected). Statistical analysis All analyses were performed using the SAS statistical software package. Chi-squared test with Yates’ correction for continuity was used to determine the statistical differences in the SSI rate between the control and evaluation groups and in the infection rate between the high risk group and control group. For comparing the differences in patients’ demographic and clinical characteristics between the control and evaluation groups, we used chi-squared test with Yates’ correction for continuity or Mann–Whitney U test. A P value of 65 years) and body mass index (>40 kg/ m2), may also affect the SSI rate [1,10,18,25,29]. However, to make the scorecard simple and practical, we did not include all possible risk factors. The reported overall SSI rate associated with ORIF surgeries ranges from 5.2% to 16% [19,21,30,32]. Using our scoring method, about one third of our patients receiving ORIF procedures were identified as having a low SSI risk. We found that the infection rate in patients with a risk score of 9 points was much higher than that in patients at low risk (10.71% vs. 2.20% in the control group), despite that prophylactic cefuroxime was used. Our finding provides initial validation of our SSI scoring method to identify patients at low risk of developing infection. This scorecard is useful and practical in predicting SSI in patients undergoing clean ORIF surgeries and can be revised and refined for assessing SSI risks in patients undergoing other surgical procedures.
188
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SSI and the use of prophylactic antibiotics in clean surgeries are complex issues. Antibiotics are not a substitute for attention to meticulous surgical procedures, and ORIF surgeries need to be conducted with the utmost aseptic precautions to minimise the occurrence of infection. Although we found that perioperative antibiotic treatment had no statistical significant effect on the SSI rate in patients at low risk, our finding should be interpreted with caution owing to the relatively small sample size in a single centre. As to the odds ratio for infection in the control group compared to the evaluation group, the point estimate is 1.11 (and 95% confidence limits are 0.49–2.49). Further studies are warranted to validate our findings and establish evidence-based systems for identifying and grading additional possible risk factors to guide the rational use of prophylactic antibiotics in surgical patients. Careful assessment of SSI risk factors and the judicious use of antibiotics can improve cost-effectiveness and patient safety while slowing the emergence of new drug-resistant organisms.
[9]
[10]
[11]
[12]
[13] [14] [15] [16]
[17]
Conclusions We designed and validated a scorecard to identify patients receiving clean ORIF surgeries who are at low risk of developing SSI. Our study suggests that the routine use of prophylactic antibiotics may not be indicated for low-risk patients undergoing clean ORIF surgeries.
[18]
[19]
[20]
Conflict of interest statement
[21]
None of the authors have received funds or had any financial sponsorship or support from any party in treating the patients, collecting the data, preparing and writing the manuscript.
[22]
Acknowledgments We gratefully acknowledge the help of all the contributing surgeons, anaesthesiologists, and nursing staff involved in this work. We thank Ms. Jun Ying in the Department of Biostatistics at MD Anderson Cancer Center for statistical consultation.
[23]
[24]
[25]
[26]
References [27] [1] Anderson SA, Li X, Franklin P, Wixted JJ. Ankle fractures in the elderly: initial and long-term outcomes. Foot Ankle Int 2008;29:1184–8. [2] Barkatali BM, Heywood N, White R, Paton RW. MRSA screening in orthopaedic surgery: clinically valuable and cost effective? A prospective analysis of 8,867 patients. Acta Orthop Belg 2013;79:463–9. [3] Bergman BR. Antibiotic prophylaxis in open and closed fractures: a controlled clinical trial. Acta Orthop Scand 1982;53:57–62. [4] Bowater RJ, Stirling SA, Lilford RJ. Is antibiotic prophylaxis in surgery a generally effective intervention? Testing a generic hypothesis over a set of meta-analyses. Ann Surg 2009;249:551–6. [5] Boxma H, Broekhuizen T, Patka P, Oosting H. Randomised controlled trial of single-dose antibiotic prophylaxis in surgical treatment of closed fractures: the Dutch Trauma Trial. Lancet 1996;347:1133–7. [6] Bratzler DW, Dellinger EP, Olsen KM, Perl TM, Auwaerter PG, Bolon MK, et al. Clinical practice guidelines for antimicrobial prophylaxis in surgery. Am J Health Syst Pharm 2013;70:195–283. [7] Bratzler DW, Houck PM. Antimicrobial prophylaxis for surgery: an advisory statement from the National Surgical Infection Prevention Project. Clin Infect Dis 2004;38:1706–15. [8] Bratzler DW, Houck PM, Richards C, Steele L, Dellinger EP, Fry DE, et al. Use of antimicrobial prophylaxis for major surgery: baseline results from
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the National Surgical Infection Prevention Project. Arch Surg 2005;140: 174–82. Bratzler DW, Hunt DR. The surgical infection prevention and surgical care improvement projects: national initiatives to improve outcomes for patients having surgery. Clin Infect Dis 2006;43:322–30. Cies JJ, Chan S, Hossain J, Brenn BR, Di Pentima MC. Influence of body mass index and antibiotic dose on the risk of surgical site infections in pediatric clean orthopedic surgery. Surg Infect 2012;13:371–6. Duckworth AD, Phillips SA, Stone O, Moran M, Breusch SJ, Biant LC. Deep infection after hip fracture surgery: predictors of early mortality. Injury 2012;43:1182–6. Fernandes A, Dias M. The microbiological profiles of infected prosthetic implants with an emphasis on the organisms which form biofilms. J Clin Diagn Res 2013;7:219–23. Formaini N, Jacob P, Willis L, Kean JR. Evaluating the use of preoperative antibiotics in pediatric orthopaedic surgery. J Pediatr Orthop 2012;32:737–40. Guglielmo BJ, Luber AD, Paletta Jr D, Jacobs RA. Ceftriaxone therapy for staphylococcal osteomyelitis: a review. Clin Infect Dis 2000;30:205–7. Haridas M, Malangoni MA. Predictive factors for surgical site infection in general surgery. Surgery 2008;144:496–501. Hauser CJ, Adams Jr CA, Eachempati SR. Surgical Infection Society guideline: prophylactic antibiotic use in open fractures: an evidence-based guideline. Surg Infect (Larchmt) 2006;7:379–405. Hughes SP, Miles RS, Littlejohn M, Brown E. Is antibiotic prophylaxis necessary for internal fixation of low-energy fractures? Injury 1991;22:111–3. Lee J, Singletary R, Schmader K, Anderson DJ, Bolognesi M, Kaye KS. Surgical site infection in the elderly following orthopaedic surgery. Risk factors and outcomes. J Bone Joint Surg Am 2006;88:1705–12. Lin S, Mauffrey C, Hammerberg EM, Stahel PF, Hak DJ. Surgical site infection after open reduction and internal fixation of tibial plateau fractures. Eur J Orthop Surg Traumatol 2013;24:797–803. Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for prevention of surgical site infection, 1999. Centers for Disease Control and Prevention (CDC) Hospital Infection Control Practices Advisory Committee. Am J Infect Control 1999;27:97–132. Morris BJ, Unger RZ, Archer KR, Mathis SL, Perdue AM, Obremskey WT. Risk factors of infection after ORIF of bicondylar tibial plateau fractures. J Orthop Trauma 2013;27:e196–200. Olsen MA, Nepple JJ, Riew KD, Lenke LG, Bridwell KH, Mayfield J, et al. Risk factors for surgical site infection following orthopaedic spinal operations. J Bone Joint Surg Am 2008;90:62–9. Ortega G, Rhee DS, Papandria DJ, Yang J, Ibrahim AM, Shore AD, et al. An evaluation of surgical site infections by wound classification system using the ACS-NSQIP. J Surg Res 2012;174:33–8. Ovaska MT, Makinen TJ, Madanat R, Huotari K, Vahlberg T, Hirvensalo E, et al. Risk factors for deep surgical site infection following operative treatment of ankle fractures. J Bone Joint Surg Am 2013;95:348–53. Paryavi E, Stall A, Gupta R, Scharfstein DO, Castillo RC, Zadnik M, et al. Predictive model for surgical site infection risk after surgery for high-energy lower-extremity fractures: development of the risk of infection in orthopedic trauma surgery score. J Trauma Acute Care Surg 2013;74:1521–7. Saveli CC, Morgan SJ, Belknap RW, Ross E, Stahel PF, Chaus GW, et al. Prophylactic antibiotics in open fractures: a pilot randomized clinical safety study. J Orthop Trauma 2013;27:552–7. SooHoo NF, Krenek L, Eagan MJ, Gurbani B, Ko CY, Zingmond DS. Complication rates following open reduction and internal fixation of ankle fractures. J Bone Joint Surg Am 2009;91:1042–9. Spellberg B, Guidos R, Gilbert D, Bradley J, Boucher HW, Scheld WM, et al. The epidemic of antibiotic-resistant infections: a call to action for the medical community from the Infectious Diseases Society of America. Clin Infect Disease 2008;46:155–64. Srinivasan CM, Moran CG. Internal fixation of ankle fractures in the very elderly. Injury 2001;32:559–63. Stall A, Paryavi E, Gupta R, Zadnik M, Hui E, O’Toole RV. Perioperative supplemental oxygen to reduce surgical site infection after open fixation of high-risk fractures: a randomized controlled pilot trial. J Trauma Acute Care Surg 2013;75:657–63. Strachan CJ. The prevention of orthopaedic implant and vascular graft infections. J Hosp Infect 1995;30(Suppl.):54–63. Suzuki T, Morgan SJ, Smith WR, Stahel PF, Gillani SA, Hak DJ. Postoperative surgical site infection following acetabular fracture fixation. Injury 2010;41: 396–9. van Walraven C, Musselman R. The Surgical Site Infection Risk Score (SSIRS): a model to predict the risk of surgical site infections. PLOS ONE 2013;8:e67167. White CB, Turner NS, Lee GC, Haidukewych GJ. Open ankle fractures in patients with diabetes mellitus. Clin Orthop Relat Res 2003;414:37–44.
Contents lists available at ScienceDirect
Injury journal homepage: www.elsevier.com/locate/injury
Evaluating the use of antibiotic prophylaxis during open reduction and internal fixation surgery in patients at low risk of surgical site infection Sheng-Gen Xu a,*, Zhao-Guang Mao a, Bin-Sheng Liu a, Hui-Hua Zhu a, Hui-Lin Pan b,** a b
Department of Orthopedic Surgery, The People’s Hospital of Jiangshan, Jiangshan City, Zhejiang 324100, PR China Department of Anesthesiology and Perioperative Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA
A R T I C L E I N F O
A B S T R A C T
Article history: Accepted 26 July 2014
Background: Widespread overuse and inappropriate use of antibiotics contribute to increasingly antibiotic-resistant pathogens and higher health care costs. It is not clear whether routine antibiotic prophylaxis can reduce the rate of surgical site infection (SSI) in low-risk patients undergoing orthopaedic surgery. We designed a simple scorecard to grade SSI risk factors and determined whether routine antibiotic prophylaxis affects SSI occurrence during open reduction and internal fixation (ORIF) orthopaedic surgeries in trauma patients at low risk of developing SSI. Methods: The SSI risk scorecard (possible total points ranged from 5 to 25) was designed to take into account a patient’s general health status, the primary cause of fractures, surgical site tissue condition or wound class, types of devices implanted, and surgical duration. Patients with a low SSI risk score (8 points) who were undergoing clean ORIF surgery were divided into control (routine antibiotic treatment, cefuroxime) and evaluation (no antibiotic treatment) groups and followed up for 13–17 months after surgery. Results: The infection rate was much higher in patients with high SSI risk scores (9 points) than in patients with low risk scores assigned to the control group (10.7% vs. 2.2%, P < 0.0001). SSI occurred in 11 of 499 patients in the control group and in 13 of 534 patients in the evaluation group during the follow-up period of 13–17 months. The SSI occurrence rate did not differ significantly (2.2% vs. 2.4%, P = 0.97) between the control and evaluation groups. Conclusions: Routine antibiotic prophylaxis does not significantly decrease the rate of SSI in ORIF surgical patients with a low risk score. Implementation of this scoring system could guide the rational use of perioperative antibiotics and ultimately reduce antibiotic resistance, health care costs, and adverse reactions to antibiotics. ß 2014 Elsevier Ltd. All rights reserved.
Keywords: Infection risk factors Prophylactic antibiotics Orthopaedic surgeries Trauma Cefuroxime Ceftriaxone
Introduction Open reduction and internal fixation (ORIF) is a commonly used orthopaedic procedure to treat fractures with excellent outcomes. However, surgical site infection (SSI), a devastating complication associated with orthopaedic implants, can prolong the length of hospital stay and dramatically increase the medical costs [16,20]. To minimise SSI occurrences, perioperative prophylactic antibiotics have been routinely used for all patients undergoing ORIF
* Corresponding author. Tel.: +86 137 5700 5877. ** Corresponding author at: Department of Anesthesiology and Perioperative Medicine, Unit 110, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd., Houston, TX 77030, USA. Tel.: +1 713 563 7467; fax: +1 713 794 4590. E-mail addresses: [email protected] (S.-G. Xu), [email protected] (H.-L. Pan). http://dx.doi.org/10.1016/j.injury.2014.07.026 0020–1383/ß 2014 Elsevier Ltd. All rights reserved.
procedures. Although it is generally accepted that prophylactic antibiotics are effective in reducing the incidence of SSI in contaminated and dirty wounds [3,5], it remains uncertain whether antibiotics should be used routinely with patients undergoing clean ORIF surgeries who are at low risk of developing SSI [13,17]. The evolution of resistant pathogens has developed into a worldwide health crisis. Rampant and unnecessary administration of antibiotics is one of the major contributors to the development of drug-resistant pathogens [28]. To prevent and reduce the spread of microorganisms resistant to treatment, we need to better understand what, when, and how antibiotics should be used [16]. In modern orthopaedic practice, a large number of patients with closed fractures undergo ORIF procedures in ultra-clean ventilated operating rooms. Nevertheless, most physicians routinely use prophylactic antibiotics for patients receiving clean ORIF procedures because of undue fear of SSI. There are some clinical
S.-G. Xu et al. / Injury, Int. J. Care Injured 46 (2015) 184–188
guidelines for the use of prophylactic antibiotics in general surgeries that are designed to reduce the rapid growth of drugresistant organisms [9]. However, there are no evidence-based clinical studies that can provide clear guidelines for the rational use of antibiotics specifically for patients undergoing ORIF surgeries. Also, there is no strong evidence regarding whether prophylactic antibiotics can reduce the occurrence of SSI in orthopaedic patients at low risk of developing infection. Although our understanding of SSI remains incomplete, various types of risk factors, such as the patient’s general health status and the degree of trauma and fractures, can contribute to the development of SSI in orthopaedic patients [18,22,24,32,34]. We reasoned that the major risk factors that predispose a person to SSI could be assessed and graded for patients receiving ORIF surgeries. A simple and easy-to-use scoring method could be applied clinically to guide the rational use of antibiotics in orthopaedic patients at low risk of SSI. Therefore, the objective of our prospective study was to design a simple SSI risk scoring system specifically for ORIF surgeries and determine whether the routine use of prophylactic antibiotics during the perioperative period reduces postoperative SSI in ORIF surgical patients at low risk of infection. We hypothesised that routine perioperative antibiotic treatment does not influence the rate of SSI occurrence in this population of patients. Patients and methods Design of SSI risk factor scorecard We designed a SSI risk factor scorecard (Table 1) by considering five major SSI risk factors associated with ORIF surgeries according to related literature about SSI in surgical patients [15,22,24,25,31,33,34]. Each risk factor was assessed as low (1 point), medium (2 points), or high (5 points). The five risk factors are general health status, primary cause of fracture, surgical site tissue condition/wound class, type of implant, and duration of surgery. Table 1 SSI risk factor scorecard for patients undergoing ORIF surgeries. Risk factor
Classification
Score
General health statusa
Healthy, no known disease Mild systemic disease Severe systemic disease (ASA score >3)
1 2 5
Primary cause of fractureb
Indirect low-energy fracture Direct low-energy fracture Direct high-energy fracture
1 2 5
Intact skin with minor soft tissue damage Minor, superficial skin abrasion Extensive, deep skin and tissue damage
1
Types of implant
Pins and screws only 1 metal plate >2 metal plates
1 2 5
Surgical durationc
4 h
1 2 5
Surgical site tissue condition/wound class
2 5
a Severe systemic disease includes diabetes, cancer, liver or kidney failure, autoimmune disease, acquired immune deficiency syndrome, sepsis, neutrophilic granulocytopenia, peripheral vascular disease, chronic obstructive airway disease, and chronic use of nicotine, alcohol or steroids. b Indirect low-energy fractures refer to fractures distal to the primary site of trauma. Direct high-energy fractures are those caused by, for example, a motor vehicle accident or a fall from high height. c Surgical duration refers to the period from skin incision to skin closure. ASA, American Society of Anesthesiologists.
185
With this scoring system, the lowest total score possible is 5 points, and the highest total score possible is 25 points. If a patient’s SSI risk score reached 9 points, at least one risk factor had been assigned the highest grade or four risk factors had been given a medium grade. Thus, we considered patients with a score of 9 points as having a high risk of developing SSI and patients with a score of 8 points having a low risk. Patient selection and data collection The study was approved by the Institutional Human Subject Ethics Committee (approval #: JY2010-2; approval date: February 1, 2010). This prospective study was conducted in the orthopaedic surgery department from March 2010 through October 2013. Patients aged >8 years of either sex who were scheduled for ORIF procedures and were able to give informed consent were included in the study. Preliminary scoring using the SSI risk factor scorecard was done by an attending surgeon; these scores were subsequently verified by the antibiotic use assessment group in the orthopaedic surgery department. A total of 3415 patients was initially assigned to group A or group B using alternating blocks of 6, and 3256 patients completed the one-year follow-up. For the purpose of this study, only a subgroup of patients at low risk of developing SSI (8 points) from group A and group B was selected for further study. Specifically, those patients with a risk score 8 in group A were then allocated to the evaluation group (no antibiotic treatment, n = 551). Group B patients at low risk were subsequently assigned to the control group (antibiotic treatment, n = 529). For all low-risk patients, the surgical incisions were classified as clean (Class I) according to the wound classification system by American College of Surgeons. All patients in the control group were given an intravenous injection of cefuroxime (0.75 g in normal saline, 3 doses; Esseti Farmaceutici) 30 min before skin incision, 12 h postoperatively, and 24 h postoperatively [6,7]. Patients in the evaluation group were not given any antibiotics during the perioperative period. All patients with a high risk score (9 points) in group A and group B received routine prophylactic cefuroxime treatment, and therefore, were not part of the study. For each patient, surgical duration was initially estimated before surgery on the basis of past clinical experience. If the surgical duration was unexpectedly prolonged, a higher score was then assigned to the patient. Whenever the score reached 9 points, the patient was excluded from the control or evaluation group, and cefuroxime was administered accordingly. SSI surveillance and management All patients were treated with standard ORIF surgical procedures. We used a two-step combination of 2% tincture of iodine and 70% isopropyl alcohol for skin preparations in the operating room. Until time of discharge, each day patients were closely monitored for signs of SSI after surgery (until the sutures were removed), asked whether they had any local pain or discomfort, and had their temperature taken. After discharge, the patients were followed up for at least 13 months for any signs of SSI. The follow-up assessment of SSI was made blind with respect to knowledge of whether antibiotics were received by patients. All cases of SSI were initially diagnosed clinically, which included the classic signs and symptoms of inflammation (progressive swelling, increasing pain, and erythema in the region) and the presence of pus at the surgical site [20]. When SSI was clinically diagnosed, microbiological assessment was performed immediately using samples collected from pus and wound aspirate according to standard protocols (culture, identification and antimicrobial susceptibility). Because SSI associated with ORIF
S.-G. Xu et al. / Injury, Int. J. Care Injured 46 (2015) 184–188
186
Table 2 Distribution of SSI risk scores in patients at low risk of SSI in the control and evaluation groups. Total score
5 6 7 8
Table 4 Fracture locations and distributions of patients at low risk of SSI in the control and evaluation groups.
Number (%) of patients
Anatomic location
Evaluation group (n = 534)
Control group (n = 499)
109 141 150 134
98 132 143 126
(20.41) (26.40) (28.09) (25.09)
Clavicle Phalanx, capitate Both forearm bones Ulna Olecranon Radius Head of radius Shaft of humerus Metatarsus Calcaneum Medial malleolus Lateral malleolus Bimalleolar Trimalleolar Both leg bones Shaft of tibia Patella Shaft of femur Intertrochantic crest of femur Neck of femur
(19.64) (26.45) (28.66) (25.25)
surgeries is a serious complication (and because both Grampositive and Gram-negative organisms may be involved), we used broad-spectrum antibiotics in an effort to control/eliminate SSI quickly. It has been shown that ceftriaxone is effective for treating Staphylococcus aureus infection in orthopaedic patients [14]. Thus, once SSI was diagnosed, the antibiotics (ceftriaxone plus levofloxacin) were administered immediately, and the choice of antibiotics was later adjusted based on the results of bacterial culture and drug sensitivity tests. A patient who did not respond to antibiotic treatment was promptly scheduled for thorough surgical debridement and irrigation, with or without implant removal (depending on whether the implant itself was infected). Statistical analysis All analyses were performed using the SAS statistical software package. Chi-squared test with Yates’ correction for continuity was used to determine the statistical differences in the SSI rate between the control and evaluation groups and in the infection rate between the high risk group and control group. For comparing the differences in patients’ demographic and clinical characteristics between the control and evaluation groups, we used chi-squared test with Yates’ correction for continuity or Mann–Whitney U test. A P value of 65 years) and body mass index (>40 kg/ m2), may also affect the SSI rate [1,10,18,25,29]. However, to make the scorecard simple and practical, we did not include all possible risk factors. The reported overall SSI rate associated with ORIF surgeries ranges from 5.2% to 16% [19,21,30,32]. Using our scoring method, about one third of our patients receiving ORIF procedures were identified as having a low SSI risk. We found that the infection rate in patients with a risk score of 9 points was much higher than that in patients at low risk (10.71% vs. 2.20% in the control group), despite that prophylactic cefuroxime was used. Our finding provides initial validation of our SSI scoring method to identify patients at low risk of developing infection. This scorecard is useful and practical in predicting SSI in patients undergoing clean ORIF surgeries and can be revised and refined for assessing SSI risks in patients undergoing other surgical procedures.
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SSI and the use of prophylactic antibiotics in clean surgeries are complex issues. Antibiotics are not a substitute for attention to meticulous surgical procedures, and ORIF surgeries need to be conducted with the utmost aseptic precautions to minimise the occurrence of infection. Although we found that perioperative antibiotic treatment had no statistical significant effect on the SSI rate in patients at low risk, our finding should be interpreted with caution owing to the relatively small sample size in a single centre. As to the odds ratio for infection in the control group compared to the evaluation group, the point estimate is 1.11 (and 95% confidence limits are 0.49–2.49). Further studies are warranted to validate our findings and establish evidence-based systems for identifying and grading additional possible risk factors to guide the rational use of prophylactic antibiotics in surgical patients. Careful assessment of SSI risk factors and the judicious use of antibiotics can improve cost-effectiveness and patient safety while slowing the emergence of new drug-resistant organisms.
[9]
[10]
[11]
[12]
[13] [14] [15] [16]
[17]
Conclusions We designed and validated a scorecard to identify patients receiving clean ORIF surgeries who are at low risk of developing SSI. Our study suggests that the routine use of prophylactic antibiotics may not be indicated for low-risk patients undergoing clean ORIF surgeries.
[18]
[19]
[20]
Conflict of interest statement
[21]
None of the authors have received funds or had any financial sponsorship or support from any party in treating the patients, collecting the data, preparing and writing the manuscript.
[22]
Acknowledgments We gratefully acknowledge the help of all the contributing surgeons, anaesthesiologists, and nursing staff involved in this work. We thank Ms. Jun Ying in the Department of Biostatistics at MD Anderson Cancer Center for statistical consultation.
[23]
[24]
[25]
[26]
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