Accepted Manuscript Infections Following Sagittal Split Osteotomy: A Retrospective Analysis of 336 Patients Carl Bouchard, DMD, MSc, FRCDC Michelle Lalancette PII:

S0278-2391(14)01246-4

DOI:

10.1016/j.joms.2014.07.032

Reference:

YJOMS 56436

To appear in:

Journal of Oral and Maxillofacial Surgery

Received Date: 1 July 2014 Revised Date:

21 July 2014

Accepted Date: 22 July 2014

Please cite this article as: Bouchard C, Lalancette M, Infections Following Sagittal Split Osteotomy: A Retrospective Analysis of 336 Patients, Journal of Oral and Maxillofacial Surgery (2014), doi: 10.1016/ j.joms.2014.07.032. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

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Infections Following Sagittal Split Osteotomy: A Retrospective Analysis of 336 Patients

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Carl Bouchard DMD, MSc, FRCDC1 Michelle Lalancette2

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[email protected]

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From: Centre Hospitalier Universitaire (CHU) de Québec Université Laval Hôpital de l'Enfant-Jésus 1401, 18e rue Québec (Québec), Canada G1J 1Z4 Tel: 418-265-8744 Fax: 418-624-3338

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1. Assistant professor of oral and maxillofacial surgery 2. Dental student

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Abstract Purpose: The purpose of this project was to determine the rate of infection following bilateral

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sagittal split osteotomy (BSSO).

Methods:

The investigators implemented a retrospective case-series study. To be included in this

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study, patients needed to have a complete medical chart and a postoperative follow up of at least 3 months. The outcome variable was postoperative infections. The

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predicator variables were type of surgery, medical comorbidities, wisdom teeth extraction, smoking, type of fixation and antibiotic prophylaxis. Descriptive and bivariate statistics were computed and the P value was set at 0.05. Multivariate analyses were performed with logistic regression. Results:

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The sample was composed of 336 patients with ages ranging from 13 to 65 years old (27.2 ± 10.6). The rate of infection was 11.3% and plates/screws were removed in 10 patients (3%). There was a statistically significant association between age and

Conclusion:

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infections (odds ratio: 1.04; 95% CI: 1.01-1.07; p = 0.02).

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The results of this study suggest that infection following BSSO is within normal range for a clean contaminated procedure. Rigid fixation of the osteotomy may decrease the need for hardware removal.

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Introduction The sagittal split osteotomy (SSO) is commonly performed to correct dento-facial

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anomalies. It was originally described by Trauner and Obwegeser in 1964 and since then, many modifications have been proposed.[1-4] The Dal Pont modification was a significant improvement.[1] By moving the lateral osteotomy forward towards the first

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molar, bony contacts are increased and the risk of non-union reduced. The introduction of rigid internal fixation was also important because it has reduced the need for

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postoperative intermaxillary fixation, improving patient’s comfort and decreasing relapse.[5-7] The procedure has gained popularity owing to its versatility, simplicity and low incidence of major complications.

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Infection is one of the most common complications encountered following this cleancontaminated procedure.[8] The exact incidence is unknown and various rates have been reported, owing to the lack of clear criteria to define infections and to the use of

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different surgical protocols, making comparison between studies difficult. Also, most studies only include a limited number of patients, making results less reliable. The ideal

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antibiotic prophylaxis regimen in orthognathic surgery has yet to be defined. Some of the risk factors associated with infections include: age, medical comorbidities (diabetes, compromised immune system, smoking), type of fixation, wisdom teeth extraction, length of surgery, number of osteotomies, etc. The aim of this study was to determine the rate of infections following SSO and identify factors affecting it in a large cohort of patients.

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Materials and methods

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The design of this research is a retrospective case-series study. The study sample was obtained from patients who underwent a bilateral SSO (BSSO) at the Centre Hospitalier Universitaire de Québec from January 1st 2008 to January 1st 2013. Inclusion criteria to

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participate in this study were the following: underwent a BSSO, had a complete medical chart, had a follow up of at least 3 months, and had post-operative radiographs

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available. Seven surgeons were involved in the treatment of those patients. Due to the retrospective nature of this study, it was granted an exemption by our institution’s IRB.

A grid for data collection was built and the following information collected: age, sex, medical comorbidities, tobacco use, type of surgery, wisdom teeth extraction, antibiotic

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protocol, type of fixation, adjunctive procedures (dental implant placement, bone grafts), follow up duration and infectious complications. An infection was diagnosed when purulent discharge, an incision and drainage, or the prescription of antibiotics was

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documented in the medical chart.

The modified SSO described by Epker was performed for all patients.[2] Most patients received 2 grams of IV cephazolin (900 mg clindamycin when allergic to penicillin) 30 minutes before the operation was started and then 2 grams (900 mg clindamycin) every 3 hours until the end of surgery. No postoperative antibiotics were prescribed. A limited number of patients received 4 grams of penicillin G potassium (900 mg clindamycin for patients allergic to penicillin) 30 minutes before the beginning of surgery and than every

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4 hours for a total of 4 doses (every 8 hours for 3 doses for clindamycin). Similarly, all patients received 80 mg of methylprednisolone 30 minutes preoperatively and then every 4 hours for a total of 4 doses. The distal and proximal segments were stabilized

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with bicortical screws (2.0 or 2.4 mm in diameter), bicortical screws and a 1.5 mm

titanium plate secured with monocortical screws or a combination of the 2 previous techniques. The technique utilized was based on the surgeon’s preferences. Bicortical

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screws were placed through the intra-oral incision with a 90° screwdriver or by a

percutaneous approach with trocar. No patient had postoperative intermaxillary fixation.

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Guiding elastics (2 or 4) were kept in place for a few weeks postoperatively.

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discharged from the hospital, all patients received a prescription for analgesics and a chlorhexidine 0.12% mouthwash to be used twice a day for 1 week. Patients were seen

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7-10 days postoperatively, then at 3 weeks and 3 months.

For univariate analyses, we report frequency tables for qualitative variables and means and standard deviations for quantitative variables. Fisher's Exact Test, chi-square test

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and student's t-test were computed to measure the bivariate association between infection and the relevant study variables collected (age, sex, smoking, type of surgery,

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antibiotics, wisdom teeth extraction and type of fixation). Multivariate analyses were performed with logistic regression. Statistical significance was defined at p < 0.05 for all statistical tests. All statistical analyses were calculated using SAS software, version 9.3.

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Results Three hundred thirty-six patients met inclusion criteria. The sample was composed of

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247 (73.5%) females and 89 (26.5%) males with ages ranging from 13 to 65 years old (27.2 ± 10.6). Twenty-two patients (6.5%) were smokers and 79 (23.5%) had their lower wisdom teeth extracted simultaneously with the osteotomy. Ninety-one (27.1%) patients

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underwent a BSSO alone, 18 (5.4%) a BSSO and a genioplasty, 167 (49.7%) a BSSO and a LeFort I osteotomy and 60 (17.9%) a combination of a BSSO, genioplasty and

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Lefort I osteotomy. Fixation of bone fragments was accomplished using bicortical screws in 196 (58.3%) cases, bicortical screws and plates with monocortical screws in 127 (37.8%) cases and with a combination of both techniques in 13 (3.9%) cases. The overall infection rate at the SSO level was 11.3% (n =38) and all occurred within 3

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months postoperatively. Plates and/or screws had to be removed in 3% (n=10) of the cases and this was performed at anytime during the postoperative period. Indications for hardware removal were either infection (n=7) or plate palpability (n=3). A summary

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of the descriptive statistics is presented in Table 1.

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It was found that age and type of surgery had a significant impact on the rate of infection (Table II). All other factors did not significantly increase this complication significantly. The logistic regression analysis demonstrated that older patients had an increased likelihood of developing a postoperative infection (odds ratio: 1.04; 95% CI: 1.01-1.07; p = 0.02). The model also showed that adding a Lefort I to a BSSO decreased the rate of infection (odds ratio: 0.36; 95% CI: 0.15-0.86; p = 0.002) (Table III). This group of patients (BSSO+ Lefort I) was the largest (n = 167; 49.7%) and composed of older

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individuals, with a mean age of 27.3 years old. In comparison, patients in the BSSO group (n = 91; 27.1%) were aged a mean of 28.3 years old, the difference did not reach statistical significance (p = 0.18). More patients in the BSSO group (n = 26; 28.6%) had

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their wisdom teeth extracted compared to the Lefort I + BSSO group (n = 32; 19.16%).

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Again, this was not statistically significant (p = 0.26).

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Discussion

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The overall rate of infection in this study was 11.3%. This is within the expected range for a clean-contaminated procedure.[9] Most were minor wound infections easily treated with antibiotics alone or with incision and drainage. One patient had a non-union on one

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side and needed revision surgery with bone graft. Six patients (1.8%) had bone

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sequestra that needed removal.

All our BSSO were rigidly fixated with bicortical screws. A monocortical 1.5 mm plate was utilized in some cases, but always with the addition of bicortical screws, never alone. This was done as some surgeons prefer to use the plate to seat the proximal segment in its ideal position instead of a stainless steel wire on the external oblique

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ridge. Some patients had a combination of both techniques, usually when a wisdom tooth had to be extracted on one side only or when bony contacts were not ideal for screws alone, as sometimes seen in cases of asymmetry. By using rigid fixation, the

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micromotion at the osteotomy site is reduced and this may explain our low incidence of

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plate and screw removal (3%). We did not use intermaxillary fixation. Alpha et al. had 26% rate of wound problems and 6.5% plate removal rate when using a semi-rigid fixation with one monocortical plate alone and a short period of intermaxillary fixation.[10] Manor et al., using a similar method, had to go back to remove hardware in 12% of their cases.[11] They included maxillary and mandibular osteotomies in their study. As for postoperative stability, studies have not shown the superiority of one technique over the other and the technique chosen is mostly based on surgeons’

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preferences. More trials with a control group must be performed to determine if a technique is superior, as having to undergo a second operation for hardware removal is

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inconvenient for patients and it increases healthcare cost.

Length of surgery and an increase in the number of osteotomies have been linked to higher rates of infections. Surprisingly, and similarly to what Alpha et al. observed,

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patients who underwent 2-jaw surgery had fewer infections in this study.[10] They explained these results in their study by the fact that bimaxillary patients were admitted

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and received intravenous antibiotics for a longer period.[10] This was not the case for our patients because for all our procedures, antibiotics were stopped immediately at the end of surgery. However, our BSSO patients were slightly older and had wisdom teeth extracted more often. These two factors are linked to increased infections in other

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studies.[10-13] Wisdom teeth extraction did not increase infections significantly in this study, but this may be due to a lack of power to demonstrate such a difference, as teeth were extracted before surgery in most cases. Brown et al. and Manor et al both showed

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that patients older than 30 years required plate removal due to infection or local wound problems more often.[11, 12] This could be explained by a decrease in periosteal blood

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supply to the mandible by the dissection required for the osteotomy. Adults rely more on this vascularization than younger individuals.

Many published studies demonstrate that antibiotic prophylaxis in orthognathic procedures may reduce the risk of infection, but the ideal regimen has yet to be determined.[14-16] Our protocol evolved over the years from intravenous antibiotics 30 minutes before the beginning of surgery and for a few doses after to only perioperative

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antibiotics. In this study, most patients received the new protocol (96.5%), so the superiority of one regimen over the other cannot be established. The long-term prescription of antibiotics for more than 24 hours after surgery have been advocated by

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some authors, but the benefits of this approach are unclear for healthy patients without specific risk factors. A Cochrane review is currently underway to identify the best

method to prevent infections in orthognathic surgery without exposing the patients to the

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risk of prolonged antibiotic therapy unnecessarily and reduce the development of

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bacterial resistance.

Clear criteria to define infections exist, but they were difficult to apply in this study because of its retrospective design.[17] We had to rely on clinical notes of different surgeons to establish that there was an infection. If an antibiotic was prescribed, we

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considered the patient infected and this could have overestimated our results. This shortcoming was partly overcome by increasing the number of participants in this

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research.

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Acknowledgement The authors would like to thank Stéphane Turcotte, M.Sc., biostatistician, for the

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statistical analyses of the data for this project.

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References

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7. 8.

9. 10.

11. 12.

13. 14.

15. 16.

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4.

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3.

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2.

Dal Pont G: Retromolar osteotomy for the correction of prognathism. J Oral Surg Anesth Hosp Dent Serv 1961;19:42 Epker BN: Modifications in the sagittal osteotomy of the mandible. J Oral Surg 1977;35:157 Hunsuck EE: A modified intraoral sagittal splitting technic for correction of mandibular prognathism. J Oral Surg 1968;26:250 Trauner R, Obwegeser H: The surgical correction of mandibular prognathism and retrognathia with consideration of genioplasty. I. Surgical procedures to correct mandibular prognathism and reshaping of the chin. Oral Surg Oral Med Oral Pathol 1957;10:677 Jeter TS, Van Sickels JE, Dolwick MF: Modified techniques for internal fixation of sagittal ramus osteotomies. J Oral Maxillofac Surg 1984;42:270 Paulus GW, Steinhauser EW: A comparative study of wire osteosynthesis versus bone screws in the treatment of mandibular prognathism. Oral Surg Oral Med Oral Pathol 1982;54:2 Souyris F: Sagittal splitting and bicortical screw fixation of the ascending ramus. J Maxillofac Surg 1978;6:198 Mangram AJ, Horan TC, Pearson ML et al.: 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 Peterson LJ: Antibiotic prophylaxis against wound infections in oral and maxillofacial surgery. J Oral Maxillofac Surg 1990;48:617 Alpha C, O'Ryan F, Silva A, Poor D: The incidence of postoperative wound healing problems following sagittal ramus osteotomies stabilized with miniplates and monocortical screws. J Oral Maxillofac Surg 2006;64:659 Manor Y, Chaushu G, Taicher S: Risk factors contributing to symptomatic plate removal in orthognathic surgery patients. J Oral Maxillofac Surg 1999;57:679 Brown JS, Trotter M, Cliffe J et al.: The fate of miniplates in facial trauma and orthognathic surgery: a retrospective study. Br J Oral Maxillofac Surg 1989;27:306 Lacey MS, Colcleugh RG: Infected screws in patients treated by mandibular sagittal split osteotomy. J Oral Maxillofac Surg 1995;53:510 Baqain ZH, Hyde N, Patrikidou A, Harris M: Antibiotic prophylaxis for orthognathic surgery: a prospective, randomised clinical trial. Br J Oral Maxillofac Surg 2004;42:506 Bentley KC, Head TW, Aiello GA: Antibiotic prophylaxis in orthognathic surgery: a 1-day versus 5-day regimen. J Oral Maxillofac Surg 1999;57:226 Lindeboom JA, Baas EM, Kroon FH: Prophylactic single-dose administration of 600 mg clindamycin versus 4-time administration of 600 mg clindamycin in orthognathic surgery: A prospective randomized study in bilateral mandibular sagittal ramus osteotomies. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2003;95:145

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1.

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Wilson AP, Gibbons C, Reeves BC et al.: Surgical wound infection as a performance indicator: agreement of common definitions of wound infection in 4773 patients. BMJ 2004;329:720

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17.

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Table 1: Descriptive statistics Descriptive statistics

Sample size Gender

336 patients

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91 (27.1%) 18 (5.4%) 167 (49.7%) 60 (17.9%)

196 (58.3%) 127 (37.8%) 13 (3.9%) 79 (23.5%)

9 (2.7%) 3 (0.9%) 273 (81.3%) 51 (15.2%) 38 (11.3%) 10 (3.0%)

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Age ± SD (range) Smokers Follow-up ± SD (range) Type of surgery BSSO BSSO + genio BSSO + LeFort I BSSO + LeFort I + genio Type of fixation Bicortical screws Plates and screws Combination of both Mandibular 3rd molar extraction Antibiotic protocol 1A 1B 2A 2B Infections Plates or screw removal

89 (26.5%) 247 (73.5%) 27.2 ± 10.6 (13-65) 22 (6.5%) 13.08 ± 7.5 (3-63 months)

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Male Female

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Study variables

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Categorical data are listed as number (percentage). Continuous measures are listed as mean ± SD (range). SD, standard deviation; BSSO, bilateral sagittal split osteotomy; Genio, genioplasty Antibiotics: 1A, Pen G potassium 2.4 million units 30 minutes before the beginning of surgery then every 4 hours for a total of 4 doses; 1B, Clindamycin 900 mg 30 minutes before the beginning of surgery then every 8 hours pour a total of 3 doses; 2A, Cephazolin 2g 30 minutes before the beginning of surgery then every 3 hours and stopped at the end of surgery; 2B Clindamycin 900 mg 30 minutes before the beginning of surgery then every 3 hours and stopped at the end of surgery.

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Table 2. Bivariate analysis

81 (27.2%) 217 (72.8%) 18 (6.0%)

0.42 0.29

14 (36.8%) 4 (10.5%) 10 (26.3%) 10 (26.3%)

77 (25.8%) 14 (4.7%) 157 (52.7%) 50 (16.8%)

0.01

1 (2.6%) 0 (0.0%) 33 (86.8%) 4 (10.5%) 8 (21.1%)

8 (2.7%) 3 (1.0%) 240 (80.5%) 47 (15.8%) 71 (23.8%)

0.77 0.70

22 (57.9%) 14 (36.8%) 2 (5.3%)

174 (58.4%) 113 (37.9%) 11 (3.7%)

0.82

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BSSO BSSO + genio BSSO + LeFort I BSSO + LeFort I + genio Antibiotics 1A 1B 2A 2B Mandibular 3rd molar extraction Type of fixation Bicortical screws Plates and screws Combination of both

8 (21.1%) 30 (78.9%) 4 (10.5%)

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Smokers Type of surgery

No infection 298 (88.7%) 26.72 ± 10.38

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Male Female

Infection 38 (11.3%) 31.12 ± 11.41

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Variables Sample size (n) Age Sex (binary)

P value N/A 0.02

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Categorical data are listed as number (percentage). Continuous measures are listed as mean ± SD (range) SD, standard deviation; BSSO, bilateral sagittal split osteotomy; Genio, genioplasty * Chi-square test for age and wisdom teeth extraction; Fisher’s exact test for other analyses Antibiotics: 1A, Pen G potassium 2.4 million units 30 minutes before the beginning of surgery then every 4 hours for a total of 4 doses; 1B, Clindamycin 900 mg 30 minutes before the beginning of surgery then every 8 hours pour a total of 3 doses; 2A, Cephazolin 2g 30 minutes before the beginning of surgery then every 3 hours and stopped at the end of surgery; 2B Clindamycin 900 mg 30 minutes before the beginning of surgery then every 3 hours and stopped at the end of surgery

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Table 3. Multivariate analysis Beta coefficient 0.59 0.28 -0.94 0.04

OR (95% CI) 1.67 (0.47-5.97) 1.23 (0.50-3.04) 0.36 (0.15-0.86) 1.04 (1.01-1.07)

P value 0.20 0.38 0.002 0.02

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Study variables BSSO + Genio Vs BSSO BSSO + LeFort I + Genio Vs BSSO BSSO + LeFort I Vs BSSO Age

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OR, odds ratio; CI, confidence interval; BSSO, bilateral sagittal split osteotomy; Genio, genioplasty

Infections after sagittal split osteotomy: a retrospective analysis of 336 patients.

The purpose of this study was to determine the rate of infection after bilateral sagittal split osteotomy...
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