Prophylactic antibiotic therapy for fractures of the maxillary sinus.
We conducted a study to examine the incidence of acute sinusitis following maxillary sinus fractures, as well as the impact of antibiotics in the postinjury period. Fifty patients who presented to our institution with a fracture of the maxillary sinus were prospectively randomized to receive either a nasal saline spray and a 3-day course of antibiotics (either amoxicillin/clavulanate or levofloxacin) or nasal saline alone; there were 25 patients in each group. After a minimum of 3 days, all patients were assessed for acute sinusitis. Follow-up data were available on 17patients (a total of 21 fractured sinuses) in the antibiotic group (68%) and 14 patients (17fractured sinuses) in the control group (56%). The groups were balanced in terms of demographics, location of fractures, mechanism of fracture, and time to follow-up. After 3 days, 95.23% of the fractured sinuses in the antibiotic group and 88.23% of the fractured sinuses in the control group exhibited signs or symptoms consistent with or suggestive of acute sinusitis. Very few sinuses in either group showed no evidence of sinusitis: only 1 in the antibiotic group (4.76%) and 2 in the control group (11.76%); this difference was not significant (p = 0.5768). We conclude that while the clinical rate of acute sinusitis after maxillary sinus fractures is high, a 3-day course of antibiotics is not effective in preventing its symptoms in the postinjury period.
The midfacial skeleton encompasses the bones of the face from the supraorbital rims to the upper alveolus. It contains multiple important structures, including the globes, the maxillary sinus, the ethmoid sinuses, the lacrimal apparatus, and multiple cranial nerves. The bones of the maxillary sinus are very thin and easily fractured. When this happens, the sinus frequently fills with a mix of blood and mucus (figure). Normal mucociliary clearance mechanisms may be disrupted. This puts patients with maxillary sinus fractures at a theoretical risk of infectious complications, including sinusitis and orbital cellulitis.
To date, the medical literature contains no data on the incidence of acute sinusitis after maxillary sinus fractures. Additionally, few studies have evaluated the need for prophylactic antibiotics immediately after maxillary sinus fractures.
In the study described in this article, we aimed to prospectively demonstrate the incidence of sinusitis after maxillary sinus fractures. We then sought to evaluate the efficacy of a prophylactic course of antibiotics in preventing sinusitis during the immediate postinjury period.
Patients and methods
Study population. Our study population was drawn from adults who presented to our urban tertiary care referral center for evaluation of blunt facial trauma and who underwent maxillofacial computed tomography (CT). When a maxillary sinus fracture was identified by the attending radiologist, the team covering facial trauma was notified. If they determined that immediate surgical management was not necessary, the patient became eligible for our study.
We excluded patients with any history of immunosuppression, as well as prisoners, pregnant women, and patients who were currently taking antibiotics for another reason. We also excluded patients whose injuries resulted from penetrating trauma.
We chose 50 patients for our study group--25 to serve as an active-treatment group and 25 as a control group. The active-treatment group was made up of 23 men and 2 women, aged 18 to 77 years (mean: 40.5), and the control group included 21 men and 4 women, aged 18 to 65 years (mean: 38.1). Patients were assigned to each group according to the last digit of their medical record number.
At study entry, 8 patients had bilateral maxillary sinus fractures. Assault was the most common mechanism of injury. The most common fracture patterns were zygomaticomaxillary complex fractures and isolated orbital floor fractures (table 1).
Treatment regimens. Most patients in the active-treatment group received a 3-day course of amoxicillin/clavulanate at 875/125 mg twice daily in addition to a nasal saline spray (antibiotic group). Those who were allergic to penicillin were instead prescribed 3 days of levofloxacin at 500 mg/day along with the spray. The patients in the control group received the saline nasal spray only. All participants were instructed to use nasal saline spray every 2 hours while they were awake until their follow-up visit. All patients were also cautioned against forceful nose blowing.
Pretreatment evaluations. Patients were asked to fill out a brief health history questionnaire. They were then assessed for major and minor signs and symptoms of acute sinusitis based on criteria developed by the RhinosinusitiS Task Force of the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS). (1) The major diagnostic factors are facial pain, facial pressure, facial fullness, nasal obstruction, purulent nasal discharge, and mucopus on nasal endoscopy. The minor signs and symptoms are hyposmia, fever, halitosis, headache, dental pain, cough, and otalgia. The taskforce defined acute sinusitis the presence of either (1) two major criteria or (2) one major and two minor criteria. Patients who meet 1 major criterion only or more than 2 minor criteria are deemed to have symptoms "suggestive" of acute sinusitis.
In our evaluation, we did not ask patients to rate their facial pain because they frequently had confounding facial soft-tissue injuries. All patients underwent bilateral flexible nasal endoscopy after the application of a topical anesthetic and a decongestant. The investigators collecting these data were not always blinded to the patients' group assignments. Patients were also asked about common side effects from their antibiotic.
Follow-up. Patients were asked to follow up with our research staff approximately 1 weekfollowing their injury. If an injury was deemed to require surgical repair after study onset, the patient was instead seen on the day of the operation, either in the clinic or, if the patient had already been admitted to the hospital, at the bedside.
Statistical analysis. The data were examined using the Fisher exact test to determine statistically significant differences between the two groups. Statistical significance was defined as p < 0.05.
Ethical and cost considerations. Approval for this study was granted by our Institutional Review Board, and informed consent was obtained from all study participants. Patients were compensated for their participation in the study and for the costs of their study-related medications.
The study was completed by 17 patients in the antibiotic group--15 men and 2 women, aged 19 to 77 years (mean: 41.3)--and by 14 patients in the control group--12 men and 2 women, aged 18 to 61 years (mean: 38.1). The remaining 8 patients in the treatment group were all lost to follow-up. Of the 11 patients in the control group who did not complete the study, 9 were lost to follow-up, 1 voluntarily withdrew, and 1 developed pneumonia that required intravenous antimicrobial therapy, which disqualified his data from the final analysis.
Group characteristics. At study's end, the groups were balanced with regard to history of smoking, previous sinus disease, previous facial fractures, and seasonal allergies, as well as other variables. No patient reported having a sinus infection at the time of his or her injury, and none had been on antibiotics during the 2 weeks preceding the injury (table 2).
All patients had blood in their sinuses on their initial diagnostic CT. The patients in the antibiotic group followed up with us an average of 5.7 days after their injury, and the controls followed up an average of 6.7 days--not a statistically significant difference (p = 0.3136). A total of 15 patients in the antibiotic group (88.24%) and 9 in the control group (64.29%) used their saline; again, the difference was not significant (p = 0.1975) (table 2).
Major and minor signs and symptoms. Of the patients who completed the study, 4 in the antibiotic group and 3 in the control group had bilateral maxillary sinus fractures. This gave us a total of 21 fractures in the antibiotic group and 17 in the control group. These patients were asked to differentiate their symptoms between the affected sides, and each side was treated as a separate fracture in the final data analysis.
In all, there were no significant differences between the two groups in the incidence of major and minor signs and symptoms for acute sinusitis. No patient developed purulent nasal drainage, and only 1 patient (a control) reported subjective fever (table 3).
Nasal endoscopy. Findings on nasal endoscopic examinations also were similar in the two groups, with no significant differences, although there was a trend toward less mucosal edema in the antibiotic group (p = 0.0873) (table 4).
Rates of acute sinusitis. Based on each patients symptoms and nasal endoscopy findings, we determined the rates of acute sinusitis for the two groups:
* In the antibiotic group, 12 of the 21 fractured sinuses (57.14%) exhibited symptoms consistent with acute sinusitis, and 8(38.10%) had symptoms that were suggestive of it.
* In the control group, 12 of the 17 sinuses (70.59%) exhibited symptoms consistent with acute sinusitis, while 3 (17.65%) had symptoms suggestive of it.
* Very few sinuses in either group showed no evidence of sinusitis: only 1 in the antibiotic group (4.76%) and 2 in the control group (11.76%).
When the two groups' symptoms were compared, there were no significant differences in the rates of symptoms consistent with sinusitis (p = 0.5057), the rate of symptoms suggestive of sinusitis (p=0.2817), or the rates of an absence of evidence of sinusitis (p = 0.5768).
Side effects. There were no significant differences between the two groups regarding the incidence of common side effects related to antibiotic use. The two groups had similar rates of nausea (35.29 vs. 35.71%; p = 1.0), vomiting (35.29 vs. 14.29%; p = 0.2399), diarrhea (5.88 vs. 7.14%;p = 1.0), and rash (5.88 vs. 0%;p = 1.0).
To the best of our knowledge, this is the first study to prospectively examine the natural history of maxillary sinus fractures from the standpoint of sinus function in the immediate postinjury period. We also examined the effect of a short, prophylactic course of antibiotics during the immediate postinjury period. Previously, other authors have simply reviewed their personal experience with short- and long-term infectious complications of midface fracture repairs.
Considerable controversy exists over the need for prophylactic antibiotics after midface fractures to prevent orbital cellulitis. Courtney et al conducted a survey of British oral and maxillofacial surgeons to determine their practice habits when treating patients with orbital blowout fractures; they found that 47% of the respondents reported prescribing prophylactic antibiotics at the time of injury. (2)
Shuttleworth et al reported a case of orbital cellulitis in a 16-year-old girl after a zygoma fracture; they concluded that antibiotic prophylaxis is necessary in all cases to prevent infectious complications. (3) In response, Newlands et al briefly reviewed their institutional data on orbital fractures. (4) They estimated that they had treated more than 500 of these fractures per year over 25 years and encountered only 2 cases of orbital cellulitis. They concluded that orbital cellulitis is sufficiently rare that antibiotics are not warranted in most circumstances.
Ben Simon et al conducted a retrospective analysis of their institutional data on orbital cellulitis after orbital blowout fractures and found only 4 cases among 497 patients. (5) All 4 patients had evidence of paranasal sinus disease before or after their injury, 3 were given prophylactic antibiotics, and 2 reported forceful nose blowing after their fracture. Lauder et al published their experience with antibiotics for complex midface trauma, noting that the postoperative infection rate was correlated with the number of fractures and the presence of open fractures. (6) Antibiotic coverage following the injuries did not appear to influence their rates of wound infection. Our group recently reported our experience with rates of chronic sinusitis after operative repair of midface fractures. (7) We found that these patients are at risk of long-term sinonasal complications from their injuries.
Evidence in the medical literature for the use of prophylactic antibiotics to prevent sinusitis after midface fractures is also lacking. Top et al in Turkey evaluated 15 patients for sinusitis after repair of midfacial fractures. (8) Using a combination of clinical examinations, standard CT, and cranial single-photon emission CT, they found that the overall incidence of sinusitis was 60%. They did not comment on the use of antibiotics in these patients, as the intention of their study was to help determine the long-term need for sinus surgery following these fractures.
Chole and Yee conducted a prospective, randomized study investigating antibiotic prophylaxis for facial fractures in 101 patients. (9) They reported that 22 patients underwent surgical management for isolated maxillary or zygoma fractures. Patients received two perioperative doses of either cefazolin or placebo. The authors reported no infectious complications in either the study group or the control group; however, they were evaluating for wound infections and not for sinusitis.
In our study, we demonstrated that acute sinusitis, as defined by the AAO-HNS's Rhinosinusitis Task Force, is very common in the immediate postinjury period. While the task forces criteria for a diagnosis of acute rhinosinusitis were not necessarily intended to be used in the setting of trauma, the task force did define rhinosinusitis as an inflammatory response manifested by the mucous membranes of the paranasal sinuses and nasal cavity. Since fractures of the paranasal sinuses certainly could cause inflammation of the sinus mucosa, we felt the criteria still applied in this situation.
While symptoms such as facial pressure, facial fullness, nasal obstruction, headache, and dental pain were common in our patient population, subjective fevers were rare and no patient developed purulent nasal discharge. Prophylactic antibiotics had no effect on any of these signs and symptoms. This suggests that many of the signs and symptoms of acute sinusitis after maxillary sinus fractures are the result of mucosal injury rather than the presence of an infectious process.
Our study has a number of limitations. First, only 50 patients were enrolled in the trial, and only 31 completed it. Also, we were unable to perform a power analysis before starting our data collection. Moreover, the patients in our trial were not blinded to their study group, and the data collectors were frequently not blinded to the patients' study group, which might have exposed our data to a bias, either for or against antibiotic use.
Another potential limitation was the duration of treatment. Our decision to use a 3-day course of antibiotics was made after we reviewed the literature on antimicrobial prophylaxis against meningitis in patients with basilar skull fractures. Basilar skull fractures often cause mucosal injuries similar to those encountered in our study, and patients are exposed to similar microbial flora. Ratilal et al addressed this subject and identified multiple prospective trials of antibiotics for basilar skull fractures in a Cochrane Database review of studies. (10) In half of the studies that they analyzed, antibiotics had been prescribed for 3 days; in fact, this was the only treatment duration that had been used in more than one study. Their review revealed that antibiotics did not have a role in the prevention of meningitis following basilar skull fractures, regardless of the duration of treatment.
Although the 3-day course of antibiotics was generally well tolerated by our patient population, we did notice a trend toward an increased incidence of vomiting in the treatment group. Antibiotic use has also been associated with other unintended consequences; most worrisome is the increasing incidence of antimicrobial resistance confronting the medical community.IU2 The best way to combat these concerns is to use antibiotics in an evidence-based fashion.
In conclusion, our study demonstrated that a 3-day course of antibiotics was not superior to nasal saline spray in the prevention of the signs and symptoms of acute sinusitis after maxillary sinus fractures from blunt trauma. We therefore do not recommend the routine use of antibiotics in cases of blunt trauma to the maxillary sinus in the acute postinjury period.
The authors thank Leroy Thacker, PhD, for his assistance in preparing the statistical analysis of this project.
(1.) Lanza DC, Kennedy DW. Adult rhinosinusitis defined. Otolaryngol Head Neck Surg 1997;117(3 Pt 2):Sl-7.
(2.) Courtney DJ, Thomas S, Whitfield PH. Isolated orbital blowout fractures: Survey and review. Br J Oral Maxillofac Surg2000;38(5) :496-503.
(3.) Shuttleworth GN, David DB, Potts MJ, et al. Lesson of the week: Orbital trauma. Do not blowyour nose. BMJ 1999;318(7190):1054-5.
(4.) Newlands C, Baggs PR, Kendrick R. Orbital trauma. Antibiotic prophylaxis needs to be given only in certain circumstances [letter]. BMJ 1999;319(7208):516-17.
(5.) Ben Simon GJ, Bush S, Selva D, McNab AA. Orbital cellulitis: A rare complication after orbital blowout fracture. Ophthalmology 2005; 112(11):2030-4.
(6.) Lauder A, Jalisi S, Spiegel J, et al. Antibiotic prophylaxis in the management of complex midface and frontal sinus trauma. Laryngoscope 2010;120(10):1940-5.
(7.) Yelverton JC, Jackson P, Schmidt RS. Chronic rhinosinusitis in patients requiring surgical repair of a midface fracture. Ear Nose Throat J 2014;93(9):E26-8.
(8.) Top H, Aygit C, Sarikaya A, et al. Evaluation of maxillary sinus after treatment of midfacial fractures. J Oral Maxillofac Surg 2004;62(10): 1229-36.
(9.) Chole RA, Yee J. Antibiotic prophylaxis for facial fractures. A prospective, randomized clinical trial. Arch Otolaryngol Head Neck Surg 1987;113(10):1055-7.
(10.) Ratilal B, Costa J, Sampaio C. Antibiotic prophylaxis for preventing meningitis in patients with basilar skull fractures. Cochrane Database Syst Rev 2006;(1):CD004884.
(11.) Chastre J. Evolving problems with resistant pathogens.Clin Microbiol Infect 2008;14(Suppl 3):3-14.
(12.) Klevens RM, Morrison MA, Nadle J, et al; Active Bacterial Core Surveillance (ABCs) MRSA Investigators. Invasive methicillin resistant Staphylococcus aureus infections in the United States. JAMA 2007;298(15):1763-71.
From the Department of Otolaryngology-Head and Neck Surgery, Virginia Commonwealth University Health System, Richmond (Dr. Schmidt and Dr. Dodson); and the Department of Otolaryngology-Head and Neck Surgery, University of Kentucky School of Medicine, Lexington (Dr. Goldman). The study described in this article was conducted at Virginia Commonwealth University.
Corresponding author: Robert S. Schmidt, MD, Department of Otolaryngology-Head and Neck Surgery, Virginia Commonwealth University Health System, PO Box 980146, Richmond, VA 23298-0146. Email: email@example.com
Funding/support: Financial support for this study was provided by the Richmond (Va.) Eye 8r Ear Foundation.
Table 1. Mechanism of injury and maxillary fracture patterns Antibiotic group Control group n = 25 n = 25 n (%) n (%) Mechanism Assault 13 (52) 10 (40) Motor vehicle accident 4 (16) 7 (28) Fall 1 (4) 5 (20) Bicycle accident 4 (16) 1 (4) Work accident 1 (4) 2 (8) Hit by automobile 1 (4) 0 Sports Injury 1 (4) 0 Fracture pattern * Zygomaticomaxillary 9 (36) 9 (36) complex Isolated orbital floor 6 (24) 9 (36) Le Fort-type 7 (28) 6 (24) Isolated anterior wall 6 (24) 2 (8) Isolated lateral wall 1 (4) 1 (4) Isolated medial wall 1 (4) 1 (4) * Some patients exhibited bilateral fractures. Table 2. Group characteristics in patients who completed follow-up Antibiotic Control group group n = 17 n = 14 p Value Variable History of smoking, n (%) 11 (64.71) 9 (64.29) 1.0000 Previous history of sinus 6 (35.29) 6 (42.86) 0.7241 infection, n (%) Previous facial fractures, 3 (17.65) 2 (14.29) 1.0000 n (%) Seasonal allergies, n (%) 6 (35.29) 3 (21.43) 0.4564 Sinus infection at the 0 0 N/A time of injury, n (%) Antibiotic use within 2 weeks 0 0 N/A of the injury, n (%) Blood in sinus on CT, n (%) 17 (100) 14(100) N/A Average follow-up 5.7 [+ or -] 6.7 [+ or -] 0.3136 (days [+ or -] SD) 2.6 3.1 Use of saline after 15 (88.24) 9 (64.29) 0.1975 injury, n (%) Table 3. Selected major and minor signs and symptoms of acute sinusitis based on the number of fractured sinuses Antibiotic Control group group n = 21 n = 17 n (%) n (%) p Value Symptom Major criteria Facial pressure 13 (61.90) 13 (76.47) 0.4862 Facial fullness 11 (52.38) 8 (47.06) 1.0000 Nasal obstruction 7 (33.33) 9 (52.94) 0.3243 Purulent nasal discharge 0 0 N/A Minor criteria Flyposmia 9 (42.86) 4 (23.53) 0.3068 Fever 0 1 (5.88) 0.4474 Halitosis 3 (14.29) 3 (17.65) 1.0000 Headache 16 (76.19) 9 (52.94) 0.1776 Dental pain 10 (47.62) 9 (52.94) 1.0000 Cough 5 (23.81) 3 (17.65) 0.7087 Otalgia 1 (4.76) 2 (11.76) 0.5768 Table 4. Findings on nasal endoscopy in the fractured sinuses Antibiotic Control group group n = 21 n = 17 n (%) n (%) p Value Finding Crusting 5 (23.81) 2 (11.76) 0.4267 Edema 4 (19.05) 8 (47.06) 0.0873 Mucopus 0 0 N/A Blood 8 (38.10) 4 (23.53) 0.4862 Normal 8(38.10) 7 (41.18) 1.0000
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|Title Annotation:||ORIGINAL ARTICLE|
|Author:||Schmidt, Robert S.; Dodson, Kelley M.; Goldman, Richard A.|
|Publication:||Ear, Nose and Throat Journal|
|Article Type:||Clinical report|
|Date:||Apr 1, 2015|
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