Int. J. Oral Maxillofac. Surg. 2014; 43: 725–731 http://dx.doi.org/10.1016/j.ijom.2014.01.012, available online at http://www.sciencedirect.com
Systematic Review Paper Orthognathic Surgery
Prescribing antibiotic prophylaxis in orthognathic surgery: a systematic review
M. A. E. M.Oomens, C. R. A. Verlinden, Y. Goey, T. Forouzanfar Department of Oral and Maxillofacial Surgery/ Oral Pathology, VU University Medical Centre/ Academic Centre for Dentistry Amsterdam (ACTA), Amsterdam, Netherlands
M. A. E. M. Oomens, C. R. A. Verlinden, Y. Goey, T. Forouzanfar: Prescribing antibiotic prophylaxis in orthognathic surgery: a systematic review. Int. J. Oral Maxillofac. Surg. 2014; 43: 725–731. # 2014 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved. Abstract. There is no consensus on the use of antibiotic prophylaxis in orthognathic surgery to prevent infections. A systematic review of randomized controlled trials investigating the efficacy of antibiotic prophylaxis was performed to make evidence-based recommendations. A search of Embase, Ovid Medline, and Cochrane databases (1966–November 2012) was conducted and the reference lists of articles identified were checked for relevant studies. Eleven studies were eligible and were reviewed independently by the authors using two validated quality assessment scales. Three studies were identified to have a low risk of bias and eight studies a high risk of bias. Most studies compared preoperative and perioperative antibiotic prophylaxis with or without continuous postoperative administration. Methodological flaws in the included studies were no description of inclusion and exclusion criteria and incorrect handling of dropouts and withdrawals. Studies investigating the efficacy of antibiotic prophylaxis are not placebo-controlled and mainly of poor quality. Based on the available evidence, preoperative antibiotic prophylaxis appears to be effective in reducing the postoperative infection rate in orthognathic surgery. However, there is no evidence for the effectiveness of prescribing additional continuous postoperative antibiotics. More trials with a low risk of bias are needed to produce evidence-based recommendations and establish guidelines.
Orthognathic surgery is a common oral and maxillofacial surgery procedure. Corrections of dentofacial and craniofacial deformities and improvements in patient aesthetics are made with good results. However, there is an inevitable risk of complications with this type of surgery. Pain, swelling, fever, neurosensory deficits, and postoperative infections are well known problems. The postoperative infection rate varies from 2% to 33.4%.1–3 It is 0901-5027/060725 + 07 $36.00/0
important to minimize the occurrence of these infections as they result in an adverse quality of life and account for extra costs due to longer hospital stays, additional surgery, and work-related absence.4–6 Only a few studies reported in the literature have investigated the efficacy of antibiotic prophylaxis in orthognathic surgery. There is still no consensus concerning the use, timing, type, and doses of
Key words: antibiotic prophylaxis; orthognathic surgery; risk of bias; methodological quality; systematic review. Accepted for publication 27 January 2014 Available online 2 March 2014
antibiotic prophylaxis because of the diverse study outcomes. One meta-analysis and one systematic review plus meta-analysis on this subject were published in 2011.7,8 The results of the study performed by Danda and Ravi8 showed that continuous postoperative antibiotic prophylaxis is effective in reducing infections. The systematic review plus meta-analysis by Tan et al.7 demonstrated that antibiotics given postoperatively are of
# 2014 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.
Oomens et al.
no extra value. Given this contradiction in two recently published meta-analyses, this thorough review of the existing available literature was done. In order to conduct a meta-analysis or a systematic review, it is necessary to accurately assess the design of the included randomized controlled trials (RCTs) to make an estimation of the effect of the risk of bias. Bias means any deviation of results or inferences from the truth, or processes leading to such a deviation. There are several lists to assess the design of an RCT. Tan et al.7 used the Cochrane Collaboration tool for their meta-analysis. However, more than 72% of the outcomes of the quality appraisal were noted as unclear, which makes the quality assessment doubtful. Danda and Ravi8 did not use a list of methodological criteria for their systematic review and metaanalysis, but divided the studies into three quality categories based on the rigour of the study. The most reliable methodological quality checklists for RCTs are the Delphi list9 and the Jadad scale,10 as published previously by Olivo et al.11 These lists are tools to assess an article on the most important risk of bias items for internal and external validity and for statistical analyses. Therefore these scales, shown in Table 1, were used in the present study.
The aim of the present study was to provide evidence-based recommendations on the efficacy of different antibiotic regimens in preventing postoperative infections after orthognathic surgery by reviewing the available RCTs after an extensive evaluation of their risk of bias. Materials and methods
This study was conducted in accordance with the PRISMA statement.12 Study identification
An electronic search of the Embase, Ovid Medline, and Cochrane databases (1966– November 2012) was conducted to identify eligible studies. Key search words that were used in various combinations with Boolean operators and truncations were: orthognathic surgery, osteotomy, infection, antibiotic treatment, antibiotic prophylaxis, and prophylactic antibiotics. A search with Medical Subject Heading (MeSH) terms was performed. The terms used in several combinations were ‘Orthognathic Surgery’, ‘Osteotomy’, ‘Antibiotic Prophylaxis’, ‘Anti-bacterial Agents’, and ‘Wound Infection’. As exclusion criteria, restrictions were placed on the language ‘English’ and solely human studies. By using the Med-
line search strategy for identifying RCTs, the studies were limited to clinical trials. There was no limitation with regard to the year of publication. Reference lists of the articles identified were searched manually for additional useful RCTs. All selected articles were assessed independently by two of the authors (YG and MO) with reference to the inclusion criteria. Inclusion criteria for RCTs were: a comparison of any type of systemic antibiotic treatment with a placebo, no treatment, or any other type of systemic antibiotic treatment to reduce the infection rate after orthognathic surgery. All systemically administered antibiotics were included, regardless of the type, concentration, duration, frequency of use, and administration scheme. Data extraction
Studies that met the inclusion criteria were assessed. Data and details concerning the antibiotic treatment for orthognathic surgery were entered on a predesigned data collection sheet. Data extracted consisted of demographic information, type of surgery, type of intervention, follow-up period, definition of infection, and infection rate. This was performed by one author (YG) and later checked by another author (MO).
Table 1. Jadad scale and Delphi list. Jadad scale 1
Randomization Was the study described as randomized? Give 1 additional point: the method to generate the sequence of randomization was described and it was appropriate (e.g. table of random numbers, computer-generated) Deduct 1 point: the method to generate the sequence of randomization was described and it was inappropriate (e.g. patients were allocated alternately, or according to date of birth or hospital number) Double-blinding Was the study described as double-blind? Give 1 additional point: the method of double-blinding was described and it was appropriate (e.g. identical placebo, active placebo, dummy) Deduct 1 point: the study was described as double-blind but the method of blinding was inappropriate (e.g. comparison of tablet versus injection with no double-dummy) Withdrawals and dropouts Was there a description of withdrawals and dropouts? (The number and the reasons for withdrawal in each group must be stated) Delphi list
1a 1b 2 3 4 5 6 7 8
Was a method of randomization performed? Was the treatment allocation concealed? Were the groups similar at baseline regarding the most important prognostic indicators? Were the eligibility criteria specified? Was the outcome assessor blinded? Was the care provider blinded? Was the patient blinded? Were point estimates and measures of variability presented for the primary outcome measures? Did the analysis include an intention to treat analysis?
Scores 0–2 0/1 Plus 1 Minus 1
0–2 0/1 Plus 1 Minus 1
/+ Answers /+ /+ /+ /+ /+ /+ /+ /+ /+
0–1 0/1 Scores 0/1 0/1 0/1 0/1 0/1 0/1 0/1 0/1 0/1
Antibiotic prophylaxis in orthognathic surgery Quality assessment of the studies
Due to their high validity, the Delphi list and the Jadad scale were used to assess the quality of the RCTs included.11 The Delphi list contains nine items answered by ‘yes’, ‘no’, or ‘don’t know’. If the answer to the question is ‘yes’ (sufficient information provided) the item is given a score of 1 point; if the answer is ‘no’ (sufficient information provided) or ‘don’t know’ (partial or no information), the item is given 0 points. The Jadad scale consists of three questions, each generating a ‘yes’ or ‘no’ response. In total 5 points can be awarded, with higher scores indicating a lower risk of bias (Table 1). In the case of ambiguity, the authors of the study were contacted for further details. Two investigators (YG and MO) assessed the RCTs independently and compared their outcomes. Disagreement was resolved by consensus between the investigators. When no agreement could be reached, a third independent investigator was consulted (TF). After quality assessment, studies were arranged hierarchically: studies with a higher score had a lower risk of bias. A cut-off point for the classification of high and low risk of bias was determined
in a consensus meeting. The combination of a Jadad score 4 and a Delphi score 6 was considered as ‘high quality’ and thus low risk of bias. In other words, ‘high quality’ studies scored 4–5 points on the Jadad scale and 6–9 points on the Delphi list. All RCTs with a Jadad score of 0–3 or a Delphi score of 0–5, were regarded as ‘low quality’ and thus high risk of bias. Statistical analysis
This study was designed as a descriptive study and no data pooling was performed. The inter-observer agreement between the assessors YG and MO for the Delphi list and Jadad scale was assessed using Cohen’s kappa coefficient. Results Literature search
In total, 1775 records were identified through the database search (Fig. 1). By searching the reference lists, 23 additional studies were identified. After removing the duplicates, 141 records and full-text articles were screened. One hundred and thirty studies did not meet the inclusion criteria
Fig. 1. Flow chart of the article selection process.
of this study and were excluded. Finally, 11 RCTs were included in this study. Quality assessment
Disagreements were resolved by consensus between the two authors; the third investigator (TF) was never consulted. Cohen’s kappa was 0.68. Three studies13–15 scored 6 or more points on the Delphi list and 4 or 5 points on the Jadad scale and were regarded as having a low risk of bias. Eight studies16– 23 with lower scores were regarded as having a high risk of bias (Table 2). Description of the studies with a low risk of bias
Table 3 shows the characteristics of the three studies with a low risk of bias. All three studies were non-funded. Two studies originated from the Netherlands13,15 and one from China.14 The antibiotics studied were amoxicillin–clavulanate, ampicillin, cefuroxime, and clindamycin. All participants were assessed for postoperative infection on the basis of the same clinical criteria in all three studies.
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Table 2. Jadad scale and Delphi list scores for the 11 studies included in the study.a Author
Ruggles and Hann17 Fridrich et al.20 Zijderveld et al.13 Bentley et al.22 Yoda et al.16 Lindeboom et al.15 Baqain et al.23 Jansisyanont et al.19 Kang et al.18 Danda et al.21 Tan et al.14
2 1 2 1 1 2 2 2 2 1 2
2 0 2 0 0 1 2 0 0 1 2
0 0 1 0 1 1 1 0 0 0 1
4 1 5 1 2 4 5 2 2 2 5
1 0 1 0 0 1 1 0 1 0 1
1 0 1 0 1 1 1 0 1 0 1
0 0 0 0 1 1 1 0 1 1 1
0 0 0 0 0 1 0 0 0 0 1
1 0 1 1 0 1 1 0 0 1 1
1 0 1 1 0 0 0 0 0 0 1
1 0 1 1 0 0 1 0 0 1 1
0 1 1 1 1 1 0 1 1 1 1
0 0 0 0 0 1 0 0 0 0 1
5 1 6 4 3 7 5 1 4 4 9
a J1: randomization; J2: double-blinding; J3: withdrawals and dropouts; D1a: randomization; D1b: allocation concealment; D2: similarity at baseline; D3: inclusion and exclusion criteria; D4: blinding of outcome assessor; D5: blinding of care provider; D6: blinding of patient; D7: statistical analysis; D8: intention to treat analysis; JT: Jadad total score; DT: Delphi total score.
Lindeboom et al.15 randomized patients to two groups. Both groups were prescribed preoperative antibiotics (clindamycin 600 mg intravenous, i.v.), but antibiotic treatment was continued postoperatively in one of the groups. No significant difference in the infection rate was observed between these two groups. Tan et al.14 randomized patients to two groups. Both groups were administered antibiotics (ampicillin 1000 mg i.v.) at induction. One group received continuous ampicillin 1000 mg i.v. four times daily for 2 days postoperatively, and the other group received amoxicillin 500 mg three times daily for 2 days postoperatively. There was no statistically significant difference in the infection rates between the two groups. Zijderveld et al.13 randomized patients to three groups: two groups with preoperative administration of antibiotics, amoxicillin–clavulanate or cefuroxime, and one placebo group. No other antibiotic prophylaxis was given. There was no significant difference between the two antibiotic groups with regard to the postoperative infection rate. However, the placebo group showed significantly more infections than both antibiotic groups. In conclusion, Zijderveld et al.13 showed that a preoperative dose of antibiotics was effective in reducing postoperative infec-
tions after orthognathic surgery. The other two RCTs with a low risk of bias14,15 concluded that additional postoperative antibiotics have no significant effect on the postoperative infection rate.
Description of studies with a high risk of bias
In total, eight studies were regarded as having a high risk of bias. Four of these studies investigated the efficacy of continuous postoperative antibiotics or a postoperative placebo, while having prescribed preoperative or perioperative antibiotics.17,18,21,23 All four studies analyzed different i.v. antibiotics: penicillin G for Ruggles and Hann,17 cefpiramide for Kang et al.,18 ampicillin for Danda et al.,21 and amoxicillin for Baqain et al.23 In the study of Baqain et al.,23 amoxicillin was switched from an i.v. to an oral administration scheme postoperatively; the other three studies continued the i.v. administration of antibiotics postoperatively. Despite these differences in the type of antibiotic, administration route, and scheme, no statistically significant differences in the infection rates were found between the groups in any of these studies.
The study of Yoda et al.16 was the only one to analyze the efficacy of two different types of antibiotic. One group received levofloxacin preoperatively and postoperatively. Perioperative and postoperative cefazolin was given to the other group. No significant difference was found. Fridrich et al.,20 Bentley et al.,22 Ruggles and Hann,17 and Jansisyanont et al.19 prescribed preoperative, perioperative, and continuous postoperative antibiotic prophylaxis to all groups and compared a short postoperative administration with a long postoperative administration. Bentley et al.22 was the only study with a high risk of bias to conclude that a long postoperative antibiotic administration is effective in decreasing the infection rate. Major methodological flaws
Major methodological flaws included no correct specification of the eligibility criteria (82%); both the inclusion and exclusion criteria had to be mentioned. Most of the studies did not include an intention to treat analysis (82%). None of the high risk of bias studies handled these criteria correctly. Where a randomization method was used, the randomization method
Table 3. Trial information for studies with a low risk of bias. na
Zijderveld et al.
0.9% sodium chloride i.v. (30 min preoperatively)
11–18% (intervention) 53% (comparison)
Yes P < 0.004
Lindeboom et al.15
Amoxicillin–clavulanate 2200 mg i.v. (30 min preoperatively) OR cefuroxime 1500 mg i.v. (30 min preoperatively) Clindamycin 600 mg i.v. (15 min preoperatively and 3 times daily for 24 h)
3% (intervention) 6% (comparison)
No P = 0.32
Tan et al.14
Clindamycin 600 mg i.v. (15 min preoperatively) + placebo 3 times daily Ampicillin 1 g i.v. (at induction) + amoxicillin 500 mg oral (3 times daily for 5 days)
29% (intervention) 14% (comparison)
No P = 0.45
Ampicillin 1 g i.v. (at induction and 4 times daily for 2 days) + amoxicillin 500 mg oral (3 times daily for 3 days)
n = number of patients included.
Antibiotic prophylaxis in orthognathic surgery was often not described accurately (45%) or the randomization was not done properly (36%). Blinding was not conducted in most of the studies (45%), or the description of the method of blinding was lacking (18%). See Table 2 for the Jadad scale and the Delphi list scores. Discussion
Antibiotic prophylaxis can be prescribed to decrease the infection rate after orthognathic surgery. The quality of the currently available literature is questionable and there is still no consensus on the efficacy of antibiotic prophylaxis. Therefore, this study was carried out to analyze the quality of the studies using methodological quality lists and investigated the effect of antibiotic prophylaxis on the infection rate. Although one meta-analysis and one systematic review7,8 have been published recently, their outcomes are contradictory, with debatable assessment of the analyzed RCTs, and uncertainty remains regarding the recommendations on the use of antibiotic prophylaxis. In their meta-analysis, Danda and Ravi8 concluded that postoperative antibiotic prophylaxis reduces the postoperative infection rate. However, the systematic review of Tan et al.7 showed no efficacy of continuous postoperative administration of antibiotics. In this study, the effectiveness of antibiotic prophylaxis was analyzed. Evidence of low risk of bias was found for the effectiveness of antibiotic prophylaxis in reducing the postoperative infection rate in orthognathic surgery.12 Zijderveld et al.13 showed that preoperative administration alone can be effective in reducing the postoperative infection rate. No evidence could be found for the effectiveness of (continuous) postoperative administration of antibiotics. Nine out of 11 of the included RCTs7,15–21,23 demonstrated that the administration of postoperative
antibiotics had no significant effect on the postoperative infection rate. Two of these nine articles7,15 were assessed to have a low risk of bias. This absence of evidence does not prove that the postoperative administration of antibiotics is not effective. It is generally known that costs, bacterial resistance, disturbance of the microbial flora, and gastrointestinal side effects should be considered when prescribing antibiotics.24 Taking this into account, a clinician should carefully weigh the advantages against the disadvantages of prescribing postoperative antibiotics for each individual patient. The quality of the included studies was analyzed critically to lay an emphasis on the risk of bias of research when interpreting the results and to provide reliable recommendations. The risk of bias of the included studies was evaluated using two methodological criteria lists, the Delphi list and the Jadad scale, which contain important risk of bias items. The assessment of the risk of bias was based on the information given in the published articles. An inadequately reported RCT assessed to be of low quality could still have a low risk of bias. To eliminate uncertainties caused by a poor study description, the authors of the included studies were contacted in the case of an unclear description. It is apparent that randomization is in important item in the design of an RCT to limit the risk of bias. Allocation concealment is a necessary component of unbiased randomization. Allocation concealment means ‘blinding of the randomization’: the next allocation is not known or cannot be guessed by the person recruiting patients into the trial. The authors would like to state the importance of differentiating between the term allocation concealment and blinding or masking. Blinding or masking means blinding of patients, care providers, or outcome assessors after a patient is already included in the trial. Neither the patient, nor
the care provider, nor the outcome assessor knows whether the patient received the intervention treatment or the placebo/control treatment. A clarification of items and recommendations for further research is summarized in Table 4. Antibiotic prophylaxis is administered when the clinician expects a fair chance of infection, depending on the type and location of the surgery. Orthognathic surgery is a clean-contaminated procedure and is expected to have a higher infection rate than non-contaminated surgery. The expected infection rate is even higher in immunocompromised patients. According to the principles described by Peterson,25 antibiotic prophylaxis should be administered in twice the usual therapeutic dose, shortly before the start of surgery, and should be re-administered during long-duration surgery when the plasma half-life of the antibiotic is exceeded two times to achieve and maintain high plasma levels of antibiotic during the surgical procedure. In the studies included in this review, preoperative and perioperative antibiotic administration were evaluated. Different definitions of preoperative and perioperative administration were used. Assuming that the set up of an operation table after induction takes approximately 15 min, the authors of this review regard administration at induction to be similar to preoperative administration and vice versa. Postoperative antibiotics are prescribed in different administration regimens, from 1 to 10 days after surgery. In this review, no distinction was made between these postoperative administration regimens. Furthermore, the studies included used different criteria for postoperative infection. Some studies described ‘unusual pain associated with the surgical site and localized, red, tender, overheated swelling’ as the clinical criteria for the diagnosis of a postoperative infection.13–15,17 These
Table 4. Definitions and recommendations for further research. Describe how patients are allocated to different groups. Examples of appropriate randomization methods: sealed Randomization envelopes, throw of dice, randomization by allotment or a computer-generated randomization table. Allocation concealment The next allocation is not known or cannot be guessed by those entering patients into the trial and can therefore be explained as ‘blinding of the randomization’. Examples of appropriate allocation concealment methods: throw of dice, sealed envelopes. Sample selection Clear description of inclusion and exclusion criteria and not a description of the study population only. Randomization must be done after inclusion. To increase external validity, include a reflection of the common population. Blinding Blinding of the surgeon, patient, and outcome assessor. For example: use of identical placebos or dummies, or the surgeon, patient, and outcome assessor are not aware of the interventions studied. Intention to treat analysis Include patients in the analysis as part of the intervention group allocated by randomization, irrespective of non-compliance and co-interventions. Describe explicitly that all patients completed the study. In the case of losses to follow-up, an intention to treat analysis as well as an alternative analysis to account for missing values (e.g. a worst-case analysis) should be performed.
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clinical symptoms can be seen in many cases without postoperative infection. Due to the heterogeneity of the study interventions and administration schemes and the differences in definition of postoperative infection, the drawing of firm conclusions about the efficacy of antibiotic prophylaxis is precluded. The study of Zijderveld et al.13 was the only one to include a placebo group. In that study, which included 54 patients, the infection rate was 52.6% in the placebo group, significantly higher than the 11.1% and 17.6% in the two intervention groups; the trial was discontinued due to this big difference in the infection rates. Currently it is assumed, based on this RCT from 1999,13 that preoperative antibiotic prophylaxis is effective in reducing the postoperative infection rate in orthognathic surgery. The prescribing of preoperative antibiotic prophylaxis is generally recommended based solely on this study. Despite the high infection rate in the placebo group, the authors of this systematic review carefully question whether this recommendation is based on enough evidence and thereby cautiously reconsider the impact of this recommendation. It will be difficult to perform further research on this topic because of a lack of ethical approval. Based on the literature currently available, preoperative antibiotic prophylaxis appears to be effective in reducing the postoperative infection rate in orthognathic surgery. No evidence of the effectiveness of (continuous) postoperative administration was found. It can be concluded, after reflecting on the 11 RCTs, one meta-analysis, and one systematic review, that there is a lack of low risk of bias research on this important topic. Current recommendations are mostly based on high risk of bias phase I and II trials. More well reported low risk of bias research including power calculations is needed to evaluate the effectiveness of antibiotic prophylaxis in reducing the postoperative infection rate in orthognathic surgery. Other factors involved in causing wound infections need to be taken into account, as well as quality of life measurements and the numerous disadvantages of prescribing antibiotics. Funding
None. Competing interests
Not required. 14.
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Address: Marjolijn Abigal Eva-Maria Oomens Department of Oral and Maxillofacial Surgery/Oral Pathology VU University Medical Centre PO Box 7057 1007 MB Amsterdam Netherlands
Tel.: +31 20 444 1150; Fax: +31 20 444 102 E-mails: [email protected]
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