International Journal of Surgery 12 (2014) 1300e1305

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Original research

A review of prophylactic antibiotics use in plastic surgery in China and a systematic review Ge-hong Li a, 1, Dian-ju Hou b, *, 1, Hua-dong Fu a, Jing-ying Guo a, Xiao-bo Guo a, Hui Gong c a Office of Hospital Infection, Plastic Surgery Hospital Affiliated to the Chinese Academy of Medical Sciences and Peking Union Medical College, Shijingshan District, Beijing 100144, China b Head and Neck Department of Plastic Surgery Hospital Affiliated to the Chinese Academy of Medical Sciences and Peking Union Medical College, Ba Da Chu Road, Shi Jing Shan District, Beijing 100144, China c Health Information Department, Plastic Surgery Hospital Affiliated to the Chinese Academy of Medical Sciences and Peking Union Medical College, Shijingshan District, Beijing 100144, China

h i g h l i g h t s  Among 13,997 cases with Class I surgical incisions in 2009e2010, 13,865 cases (99.1%) were given prophylactic antibiotics.  Antibiotics were administered postoperatively in >99% of cases while preoperative administration in 32 cases (0.23%).  Wound infections occurred in 21 cases for an overall infection rate of 0.15%.  Systematic review revealed marked variation in the timing and wound infections for the use of antibiotic administration.  Prophylactic antibiotics are overused in plastic surgical procedures, and there is broad variation in drug administration.

a r t i c l e i n f o

a b s t r a c t

Article history: Received 23 January 2014 Received in revised form 27 August 2014 Accepted 25 October 2014 Available online 31 October 2014

The purpose of this study was to investigate the use of antibiotic prophylaxis for plastic surgical procedures at our hospital, and to perform a systematic literature review of randomized controlled trials evaluating the use of prophylactic antibiotics in plastic surgery. The records of patients who received plastic surgical procedures with Class I surgical incisions between 2009 and 2010 were retrospectively reviewed. A systematic literature review was conducted for studies examining the use of prophylactic antibiotics for Class I surgical wounds. A total of 13,997 cases with Class I surgical incisions were included. Prophylactic antibiotics were given in 13,865 cases (99.1%). The antibiotics used were primarily cefuroxime, clindamycin, metronidazole, cefoxitin sodium, and gentamicin. The average duration of administration was 4.84 ± 3.07 (range, 1e51) days. Antibiotics were administered postoperatively in >99% of cases while preoperative antibiotic administration was only given in 32 cases (0.23%). Wound infections occurred in 21 cases for an overall infection rate of 0.15%. Fourteen studies met the inclusion criteria of the systematic review. There was marked variation in the timing of antibiotic administration with antibiotics given pre-, peri-, and postoperatively. Of studies that compared the use of prophylactic antibiotics with placebo, a reduction in wound infections was noted in 4 trials and no difference was noted in 6 trials. No significant difference in infection rates was shown between the prophylactic and postoperative arms. In conclusion, prophylactic antibiotics are overused in plastic surgical procedures. Evidence-based guidelines for the use of prophylactic antibiotics in plastic surgical procedures are needed. © 2014 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.

Keywords: Prophylactic antibiotics Class I surgical wound Infection

1. Introduction

* Corresponding author. E-mail address: [email protected] (D.-j. Hou). 1 The first two authors contributed equally to this work. http://dx.doi.org/10.1016/j.ijsu.2014.10.029 1743-9191/© 2014 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.

Surgical site infections are defined as infections that occur near or at a surgical incision within 30 days of the surgery, and are a major cause of morbidity in patients that have undergone surgery [1]. Surgical antibiotic prophylaxis refers to the short-term

G.-h. Li et al. / International Journal of Surgery 12 (2014) 1300e1305

administration of antibiotics before the beginning of surgery, and has clearly been shown to reduce the incidence of surgical site infections [2]. Prophylaxis with antibiotics has been shown to be effective in many procedures including gastrointestinal, oropharyngeal, vascular, open heart, obstetric and gynecological, and orthopedic, and clear recommendations for their use have been developed [1,2]. Because their use is preventative they are used in operations in which minimal microbial contamination of the surgical site is expected, e.g., clean Class I surgical wounds [1,2]. General principles of antibiotic prophylaxis indicate that the first dose should be given before the incision, the antibiotic should be effective for the causative organism of the potential infection, a full therapeutic dose should be administered, and antibiotics should be continued no longer than 24 h after the procedure is completed [1,3]. While clear guidelines have been established for antibiotic prophylaxis in many surgical procedures, guidelines for their use in plastic surgical procedures are lacking, and some experts consider their use unwarranted in “clean” procedures because the rate of infections is so low [1,2]. However, the use of prophylactic antibiotics in clean surgery is widespread and their timing of administration and selection is often based on convention and personal and local departmental preferences. There is also a tendency towards excessive administration of antibiotics, and lack of sufficient robust evidence on which to base such decisions for antibiotic prophylaxis in plastic surgery. In 2004 Ministry of Health in China published the “Principles and guidelines for clinical applications of prophylactic antibiotics” [4]. In the wake of the long history of prophylactic antibiotics abuse in China, the Ministry of Health published official guidelines for the clinical use of prophylactic antibiotics in February 2012, titled: “Principles of managing the clinical application of prophylactic antibiotics” [5]. The guidelines were implemented in August 2012. According to the regulations, prophylactic antibiotics are classified into 3 categories: use without restriction, use with restriction, and antibiotics used in special circumstances. When combined, there should be no more than 2 antibiotics (intravenously or orally, respectively) prescribed within the same group of prophylactic antibiotics. Hospitals and medical centers are required to record the supply and usage of prophylactic antibiotics. Physicians are required to refer to official guidelines for the application of prophylactic antibiotics. The guidelines state that for clean surgeries, antibiotics should be given within ½ to 2 h prior to the procedure or with anesthesia pre-medications, and that the effect of prophylactic antibiotics should cover the duration of surgery and 4 h after the surgery, and should not be administered for more than 24 h in total. Evaluation of the rationality of prophylactic antibiotic therapy was carried out according to the guidelines at our hospital, a center that specializes in plastic surgery, which are based on the guidelines above. It was concluded that irrational application of prophylactic antibiotics includes: 1) A rate of prophylactic antibiotic application >30%; 2) Administration of antibiotics for a duration of 24 h 0.05 for regimen I vs. II p ¼ 0.42

No antibiotic

3d

18%

25%

29%

p > 0.91

e

e

1.5%

e

p > 0.05

Placebo

5d

13%

4%

15%

p ¼ 0.19 (for all)

No antibiotic

4d

0%

e

0%

N/A

e

Placebo

e

17.7%

e

18.8%

p ¼ 0.79

e

Placebo

e

2.3%

e

4.2%

p > 0.05

e

Placebo

e

6.6%

e

12.2%

p < 0.05

e

Placebo

e

6.5%

e

7.0%

p > 0.05

Pre-, peri-: sulbactam- ampicillin 2 g IV once Post-: none Pre-, peri-: sulbactam- ampicillin 2 g IV once Post-: none

e

Placebo

e

1.3%

e

2.0%

p > 0.05

e

Placebo

e

6.0%

e

5.0%

p > 0.05

Pre-, peri-: sulbactam- ampicillin 2 g IV once Post-: none Pre-, peri-: sulbactam- ampicillin 2 g IV once Post-: none

e

Placebo

e

5.3%

e

7.3%

p > 0.05

e

Placebo

e

5.0%

e

5.4%

p > 0.05

Pre-, peri-: cefazolin 1 g IV (alt levofloxacin 500 mg IV) once Post-: none

Pre-, peri-: amoxicillineclavulanic acid 1.313 g PO once Post-: none pre-, peri-: Flucloxacillin 1 g IV once Post-: placebo 1 tablet PO qid Pre-, peri-: clarithromycin 500 mg PO twice daily Post-: clarithromycin 500 mg PO twice daily Pre-, peri-: augmentin 1.2 g IV once Post-: none Pre-, peri-: cefonicid 1 g IV once Post-: none Pre-, peri-: cefonicid 1 g IV once Post-: none Pre-, peri-: sulbactam- ampicillin 2 g IV once Post-: none

0.5%

1303

Regimen II

Pre-, peri-: none Post-: amoxicillin-clavulanate 375 mg PO tid (alt erythromycin 500 mg PO qid)

Regimen I

G.-h. Li et al. / International Journal of Surgery 12 (2014) 1300e1305

First author (year)

(continued on next page)

249 Skin grafts for clean reconstructive surgery following burn injury Alexander (1982) [20]

339 Plastic surgery Amland (1995) [19]

Ref. no., reference number; pre-, preoperative; peri-, perioperative; post-, postoperative; alt, alternative antibiotic treatment for patients allergic to designated regimen; IV, intravenous; PO, oral; d, days; N/A, not assessed.

p < 0.03 5.7% e 0.8% Placebo e

e

p < 0.01 20.5% e 5.1% Placebo e

e

2.5% e 0.2% Saline Griego (1998) [18]

790

Pre-, peri-: nafcillin sodium 0.5 mg/ ml IV once Post-: none Pre-, peri-: azithromycin 1000 mg PO once (for adults and children above 45 kg) Post-: none Pre-, peri-: cephalothin 15 mg/kg IV once (with preoperative medications), once (beginning of incision) Post-: cephalothin 15 mg/k IV once (4 h after surgery)

e

e

13.0% e 6.0% Placebo

Axillary lymph node dissection (alone or in combination with a segmental mastectomy, total mastectomy, or wide local excision) Dermatologic surgery Bold (1998) [17]

178

Pre-, peri-: cefonicid 1 g IV once Post-: none

e

e

Regimen I Control Antibiotic regimen II

Treatment duration Antibiotic regimen I

Regimen II

Control

p-value Infection rate Treatment Sample size Type of surgery First author (year) Ref. no.

Table 4 (continued )

p ¼ 0.03

G.-h. Li et al. / International Journal of Surgery 12 (2014) 1300e1305

p ¼ 0.08

1304

4. Discussion The results of the clinical study showed that the administration of prophylactic antibiotics for plastic surgical procedures at our hospital are not in line with the guidelines for antibiotic use recently published by the Ministry of Health. Overall, antibiotics were administered too frequently, the antibiotics administered were not appropriate for the potential causative organisms, and the timing and duration of administration were not appropriate. Results of the systematic review also indicated broad variation in the antibiotic administered and in the timing and dosage administered. In addition, in approximately 50% of the studies there was not difference in the infection rate of patients in whom antibiotics were given prophylactically and those who did not receive antibiotics. Though prophylactic use of antibiotics are recommended for some surgical procedures, and the prophylactic effect of antibiotics on surgical site infections is indisputable, antibiotic therapy is not required for all surgeries [1,2,21]. The incidence of surgical site infection is closely related to the cleanliness of the surgery itself. Most surgeries are aseptic, the rate of postoperative infection is about 2%, and the most commonly seen pathogens are S. aureus and Staphylococcus epidermidis [1,2,22]. The range of antibiotic application is relatively broad in plastic surgical procedures, and perioperative prophylactic antibiotic therapy is a powerful method for preventing the postoperative infections, enhancing the safety of surgery, and increasing the recovery rate [23]. In addition, antibiotics are clearly important for certain procedures in which although the risk of infection is low, the results of an infection may be significant [24]. There have been other systematic reviews regarding the use of prophylactic antibiotics in different reconstructive surgical procedures. Phillips et al. [25] reviewed antibiotic use in breast reconstruction and found that the infection rates in patients receiving no antibiotics, antibiotics for a duration 24 h were 14.4%, 5.8%, and 5.8%, respectively. A recent Cochrane Database review by Bunn et al. [26] examining prophylactic antibiotics to prevent surgical site infection after breast cancer surgery concluded that antibiotics administered preoperatively reduce the risk of SSI in this group of patients. In 2008 Tadiparthi [27] examined the evidence for the use of prophylactic antibiotics in clean, non-implant plastic surgery and concluded that while the use of antibiotics is widespread their use is primarily based on convention and personal preference and that there is insufficient evidence on which to base decisions to administer them. While it may be argued that the use of prophylactic antibiotics will “do no harm” and may prevent a SSI, the indiscriminate use of antibiotics is harm-free. It is well known that broad-spectrum antibiotics can lead to bacterial resistance and super-infection and there is always a risk of allergic reaction. Abuse of antibiotics has induced bacterial resistance on a global scale, making compliance with guidelines for administration critical [28,29]. There are some limitations of this study that should be considered. The clinical study was retrospective in nature, and an analysis by type of surgical procedure was not performed. The results of the clinical study clearly showed there was not compliance with the 2012 guidelines; a follow-up study since the guidelines have been published to determine compliance is planned. The primary limitation of the systematic review is that only RCTs were included and no specific analysis based on surgical procedure was conducted. 5. Conclusions In summary, the use of prophylactic antibiotics for plastic surgical procedures at our hospital do not meet recently published

G.-h. Li et al. / International Journal of Surgery 12 (2014) 1300e1305

guidelines. Overall, antibiotics were administered too frequently, the antibiotics administered were not appropriate for the potential causative organisms, and the timing and duration of administration were not appropriate. Results of the systematic review also indicated broad variation in the antibiotic administered and in the timing and dosage administered. Clear, evidence-based guidelines for the use of prophylactic antibiotics in plastic surgical procedures are needed. Acknowledgments None. Ethical approval This study was approved by the Institutional Board of the Plastic Surgery Hospital affiliated to the Chinese Academy of Medical Sciences and Peking Union Medical College, and because of the retrospective nature the requirement of patient informed consent was waived. Funding None. Conflict of interest None. Author contribution Dianju Hou: Guarantor of integrity of the entire study. Gehong Li: Study design, definition of intellectual content, literature research, clinical studies, draft and revision of the manuscript. Hui Gong: Data acquisition. Huadong Fu, Jingying Guo, Xiaobo Guo: Data analysis. References [1] A.J. Mangram, T.C. Horan, M.L. Pearson, L.C. Silver, W.R. Jarvis, Guideline for prevention of surgical site infection, 1999. Hospital infection control practices advisory committee, Infect. Control. Hosp. Epidemiol. 20 (1999) 250e278. [2] S.M. Gordon, Antibiotic prophylaxis against postoperative wound infections, Cleve Clin. J. Med. 73 (Suppl. 1) (2006) S42eS45. [3] J.J. Stulberg, C.P. Delaney, D.V. Neuhauser, D.C. Aron, P. Fu, S.M. Koroukian, Adherence to surgical care improvement project measures and the association with postoperative infections, JAMA 303 (2010) 2479e2485. [4] Ministry of Health, China, Principles and Guidelines for Clinical Applications of Prophylactic Antibiotics, Ministry of Health, Beijing, 2004. Available at: www. former.sfda.gov.cn/cmsweb/webportal/W4247/A63999500.html (accessed 28.10.13). [5] Ministry of Health, China, Outlines for Managing Clinical Applications of Prophylactic Antibiotics, Ministry of Health, Beijing, 2012. Available at: www. gov.cn/flfg/2012-05/08/content_2132174.htm (accessed 28.10.13). [6] P.M. Glat, M.T. Longaker, Wound healing, in: S.J. Aston, R.W. Beasley, C.H.M. Thorne (Eds.), Grabb and Smith's Plastic Surgery, Lippincott-Raven, Philadelphia, PA, 1997.

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A review of prophylactic antibiotics use in plastic surgery in China and a systematic review.

The purpose of this study was to investigate the use of antibiotic prophylaxis for plastic surgical procedures at our hospital, and to perform a syste...
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