Antibiotic prophylaxis for bilateral sagittal split osteotomies: a randomized, double-blind clinical study

Abstract

The goal of this study was to determine the efficacy of one dose and a short course (3 doses) of amoxycillin therapy for the prevention of infection following bilateral sagittal split osteotomy (BSSO). Patients who qualified for the trial were randomly divided into two groups: group I patients were given a single injection of amoxycillin 1.0 g administered preoperatively followed by two postoperative doses of saline four hourly (single dose group); group II patients were given single injection amoxycillin 1.0 g administered preoperatively followed by two postoperative doses of amoxycillin 0.5 g four hourly. The 60 patients included in this study were divided into two groups of 30. The patients were evaluated for 2 months for postoperative infections. In the postoperative period, six patients required rescue antibiotics in the single dose group and one in the short course group ( P = 0.04). There was a statistical difference in the rates of infection between the two groups ( P = 0.04). The findings indicate that a short postoperative course of antibiotics is more effective than a single preoperative dose for the prevention of infection following BSSO.

Bilateral sagittal split osteotomy (BSSO) is an indispensable surgical procedure for the correction of lower jaw deformities. It has been advocated for almost every move that includes the entire horizontal ramus of the mandible. In the classical wound cleanness classification, normal orthognathic surgery wounds fall into the Class II category (clean contaminated wound). Such procedures are expected to have an incidence of postoperative infection of 10–15%, but with the use of standard aseptic techniques and antibiotic prophylaxis a lower incidence should be achieved but wound infection remains an occasional problem. The basic purpose of antibiotic prophylaxis is to provide an adequate drug level in the tissues before, during, and for the shortest possible time after the procedure. Some studies have reported high infection rates in the case of mandibular osteotomies. Most of the studies combine all the orthognathic procedures, therefore it is difficult to conclude that a preoperative dose provides adequate antibiotic coverage for all the types of orthognathic procedures. The authors have designed a study for single procedure of orthognathic surgery (BSSO).

The purpose of this prospective randomized, double-blind clinical study is to determine the efficacy of one preoperative dose of amoxycillin 1.0 g compared to a short course of amoxycillin (one preoperative dose of 1.0 g amoxycillin and two postoperative doses of amoxycillin 0.5 g four hourly) in the prevention of infection following bilateral mandibular sagittal split osteotomies. In maxillofacial surgery, infections mainly result from contamination with Staphylococci, Streptococci and anaerobic Gram-positive and Gram-negative rods. Most bacteria cultured during dental infection are susceptible to amoxycillin. Amoxycillin was chosen as the antimicrobial agent because it remains the drug of choice against most oral microorganisms.

Materials and methods

60 patients undergoing BSSO were enrolled in this prospective randomized, double-blind clinical study. The study protocol was approved by the Institutional Ethics Committee, and written informed consent was obtained from the patients. Surgery was performed intraorally followed by semi rigid fixation. Mandibular third molars were removed at the time of surgery. Two patients had missing left lower third molars. No bone grafts or suction drain were used. Patients were randomly divided into two groups. All patients were given amoxycillin 1.0 g intravenously at induction. Group I patients received two postoperative doses of saline solution intravenously four hourly and group II patients received two postoperative doses of 500 mg amoxycillin intravenously four hourly. Exclusion criteria were: the use of antibiotics in the month before surgery; immunocompromised patient; duration of surgery exceeded 5 h; allergy to penicillin antibiotics.

All patients scheduled to undergo surgery underwent compulsory oral prophylaxis. The patients were evaluated every day during the first 4 days and every week for 2 months for any postoperative infections in reference to the criteria for defining a surgical site infection (SSI), recommended by the Centers for Disease Control and Prevention (CDC).

Postoperative wound infection was defined by at least one of the following criteria: purulent drainage from the surgical site; at least one sign or symptom of infection (pain or tenderness, localized swelling, redness, and a superficial incision deliberately opened by the surgeon, unless the incision is culture-negative); clinician diagnosis of infection.

The two groups were compared using the χ 2 test for variables such as smoking, alcohol, gender, age and operating time. The rates of infection in the two groups were compared using the χ 2 corrected test. The level for a significant difference was set at P ≤ 0.05. Calculations were performed using the statistical package for the social sciences (SPSS for Windows, ver.150, SPSS Inc., Chicago, IL, USA).

Results

60 patients were included in the study and were divided into two groups of 30. In group I, 13 patients were female and 17 male. In group II, 16 were female and 14 male. All the patients had regular follow-up. The median operation time was 120 min (range 90–150 min). In group I the mean age was 26 years (range 17–35 years). In group II the mean age was 27 years (range 17–37 years). Both groups were comparable with regards to smoking ( P = 0.4), alcohol ( P = 0.6), gender ( P = 0.4), age ( P = 0.3) and operating time ( P = 0.5). In group I, six patients were infected and in group II, one patient was infected ( P = 0.04) ( Table 1 ). Of seven infected patients, six patients had undergone mandibular advancement surgery and one patient had undergone mandibular setback ( Tables 2 and 3 ).

Table 1
Infection rate following administration of a single dose or a short course of amoxycillin.
Infection
Present Absent Total
Dose
Single dose 6 (20%) 24 (80%) 30 (100%)
Short dose 1 (3.33%) 29 (96.57%) 30 (100%)
No. of patients 7 (11.66%) 53 (87.9%) 60
P = 0.04 (statistically significant P < 0.05).

Table 2
Comparison of the infection rate between mandibular advancement and setback in the single dose group.
Group I (30 patients) Mandibular advancement (16 cases) Mandibular setback (14 cases)
Infection 4 cases (25%) 2 cases (14.3%)
No infection 12 cases (75%) 12 cases (85.7%)
P = 0.464 (not significant).

Table 3
Comparison of the infection rate between mandibular advancement and setback in the short course group.
Group II (30 patients) Mandibular advancement (13 cases) Mandibular setback (17 cases)
Infection 1 case (5.9%) 0 case (0%)
No infection 16 cases (94.1%) 13 cases (100%)
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Jan 24, 2018 | Posted by in Oral and Maxillofacial Surgery | Comments Off on Antibiotic prophylaxis for bilateral sagittal split osteotomies: a randomized, double-blind clinical study
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