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British Journal of Oral and Maxillofacial Surgery (2004) 42, 506510

Antibiotic prophylaxis for orthognathic surgery:a prospective, randomised clinical trial

Zaid H. Baqaina,, Nicholos Hydeb, Anna Patrikidouc, Malcolm Harrisd

a Oral and Maxillofacial Surgery Department, Faculty of Dentistry, University of Jordan, Amman, Jordanb Consultant Oral and Maxillofacial Surgeon, St. Georges Healthcare NHS Trust,

Blackshore Road, London SW17 0QT, UKc Eastman Dental Institute, 256 Grays Inn Road, London WC1X 8LD, UKd Oral and Maxillofacial Surgery, Eastman Dental Institute, 256 Grays Inn Road,

London WC1X 8LD, UK

Accepted 19 June 2004Available online 14 August 2004

KEYWORDS

Postoperative infection;

Swelling;

Infection score

Summary A prospective, randomised, placebo-controlled double-blind clinicaltrial, compared short-term (1 day) and long-term (5 days) antibiotic prophylaxisafter orthognathic surgery. Thirty four patients had single jaw or bimaxillary os-

teotomies and were given two perioperative doses of amoxycillin. Patients werethen randomised to receive either placebo or amoxycillin for 5 days in a double-blind manner. Postoperatively the patients were monitored for infection by scoringa series of validated measurements of infection. In the postoperative period fourpatients required additional antibiotics in the short-term group and two in the long-term group (P = 0.67). Morbidity scores were higher in the short-term group, at 406to 264 (P = 0.04), and when individual variables were compared there was a sig-nificant difference in the degree of swelling (P = 0.04). Although a 5-day regimenof antibiotic prophylaxis in orthognathic surgery did not decrease the incidence ofpostoperative infection significantly, it may decrease the morbidity of the operation. 2004 Published by Elsevier Ltd on behalf of The British Association of Oral andMaxillofacial Surgeons.

* Corresponding author. Present address: P.O. Box 125, IskanAlia, Amman 11731, Jordan. Tel.: +962 79 5609063

E-mail address: [email protected] (Z.H. Baqain).

1. Introduction

Orthognathic surgery aims to normalise the rela-tionship of the jaws and the craniofacial complex,and to correct problems with eating and speaking.However, most patients are operated on for aes-thetic reasons.1

0266-4356/$ see front matter 2004 Published by Elsevier Ltd on behalf of The British Association of Oral and Maxillofacial Surgeons.doi:10.1016/j.bjoms.2004.06.010


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Orthognathic procedures are classified asclean-contaminated operations, in that theyconsist of an incision through a mucosal surfacewith a rich endogeous flora. Such operations areexpected to have an incidence of postoperativeinfection of 10%15% but with the use of standardaseptic techniques and antibiotic prophylaxis alower incidence should be achieved.2,3 Despite thisthe reported rate of postoperative infection, withthe use of antibiotic prophylaxis, still ranges from5.6% to 33.4%, and usually develops during the firstfew weeks postoperatively.47 The efficacy of an-tibiotic prophylaxis in orthognathic surgery is wellestablished8,9 and its importance was highlightedby a prospective, randomised study conductedby Zijderveld et al. in 1999.10 However, previousretrospective non-randomised studies have chal-lenged the need for prophylactic antibiotics, on thegrounds that in the absence of primary infection

antibiotics are unjustified and merely predisposeto the development of resistant strains.11,12 Mi-crobiologists also maintain that there is no benefitin prolonging a course of antibiotics once theoperation has been successfully completed. Thisdisagreement about the use and duration of antibi-otic prophylaxis might may be related to the widerange in the reported postoperative infection rates.

The purpose of this study was to find outin a prospective, randomised, placebo-controlled,double-blind clinical trial, whether short-term (1day) prophylaxis is as effective as long-term (5 days)

prophylaxis in preventing postoperative infection.Amoxycillin was used as the drug of choice be-cause of its safety and efficacy against oral micro-organisms, and patients allergic to penicillin weregiven clindamycin.

2. Patients and methods

Ethical Committee approval was granted, and maleand female patients listed to undergo orthognathic

Table 1 Operations done.

Operations Long-term (n = 17) Short-term (n = 17) Total (n = 34)

Bilateral sagittal split osteotomy (BSSO), Le Fort I 10a 9b 19BSSO, Le Fort I, genioplasty 1 2 3BSSO, maxillary segmental osteotomy 1 0 1Le Fort I, manibular segmental osteotomy 0 1 1BSSO 5 3 8Le Fort I 0 1 1Maxillary segmental osteotomy 0 1 1

a Lyophilised cartilage was used to augment the angles of the mandible in one case.b Autogenous bone grafts were used for the mandible in one case.

operations were sequentially invited to participatein the study. Written informed consent was ob-tained from all patients. Exclusion criteria includedthe use of antibiotics in the month before the op-eration, lactose intolerance (as the placebo waslactose-based) and patients who had previous or-thognathic operations. The total number of pa-tients included was 34, 17 in each group.

The antibiotic prophylaxis protocol was as fol-lows:

All patients were given amoxycillin 1 g intra-venously at induction, followed by 500 mg intra-venously 3 h postoperatively. The long-term groupwere then given amoxycillin 500 mg orally every 8 hfor 5 days and the short-term group were givenplacebo orally every 8 h again for a total period of5 days.

Patients allergic to penicillin were given clin-damycin 300mg intravenously at induction and

150mg 3 h postoperatively. The long-term groupcontinued taking clindamycin 150 mg orally every6 h for a total of 5 days, while the short-term groupwere given placebo.

Several orthognathic operations were done(Table 1), all through an intraoral approach usingrigid fixation. None of the patients required inter-maxillary fixation.

Seven variables from a previously validatedsystem were used to audit postoperative infec-tion,1316 including: facial swelling (score 03 fornil, minor, moderate, and gross swelling). This was

a subjective assessment by ZB. Pain was scored on avisual analogue scale (VAS) (04 for nil, mild, mod-erate, severe, and excruciating). The remainingfive criteria were scored as presence or absence:extraoral erythema 0 or 5; wound exudate 0 or 10;isolation of pathogens 0 or 10; pyrexia 0 or 10; andwound dehiscence 0 or 10. The total achievablescore for severe infection was therefore 52.

The list of random numbers was prepared andkept by the clinical pharmacist and the dispensedcapsules were unmarked so that neither the pa-


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508 Z.H. Baqain et al.

tient nor the assessor knew the regimen. Only oneassessor (ZB) was involved in reviewing and com-pleting the score sheets for the patients. Patientswho failed to attend a follow up appointment wereasked to attend a day or two later. None of the pa-tients was lost to follow up over the 6-week period.

Patients were reviewed weekly, from the firstpostoperative day for 6 weeks. A score sheet wasfilled in for each patient at each visit; each variablewas scored and then the total score for each visitwas calculated. At the end of the trial the variablesfor the two groups were compared using Fishersexact test for variables such as sex, smoking, andalcohol consumption and the MannWhitney U-testfor age and operating time. Analyses was also madeon (a) the weekly sum of each variable, and (b)the total sum of the repeated measures for all thepatients in each group. The software used for theanalysis was the Statistical Package for the Social

Sciences (SPSS, version 10.0).

3. Results

Thirty-four patients were included in this study,23 women and 11 men, 17 in each group. Therewere no withdrawals. Their mean age was 27 years(range 1848). The median operation time was180min (range 65340), 205 min for bimaxillary(range 130340) and 123 min for single jaw pro-cedures (range 65220), the usual number of sur-

geons at each operation was three. Only one patientwas allergic to penicillin and was given clindamycin.The number of patients who required additionalrescue antibiotics in the short-term group wasfour compared with two in the long-term group (P= 0.67). All the infections were unilateral and oc-curred in the mandible in the area of the buccalflap.

Both groups were comparable with regards to sex(P= 0.3), smoking (P= 0.7) and alcohol consumption(P= 0.7). Age (P= 0.9) and operating time (P= 0.3)were also comparable.

The sum of the total scores was significantly

higher in the short-term than in the long-termgroup, at 406 to 264 (P= 0.04). Patients in the short-term group also developed more swelling after thethird postoperative visit (Figure 1), and the differ-ence in swelling score was significant (P = 0.3). Al-though the scores for the other variables were gen-erally higher in short-term group (Figure 2), the dif-ferences were not significant.

Infection developed in the long-term group amedian of 25 days postoperatively (range 2128)but earlier in the short-term group 11 days (range419). This was of interest but not significant.

Figure 1. Median values for swelling. The squares indi-cate the short-term group; and the diamonds the long-term group.

Swabs for culture were taken from the four pa-tients with a purulent discharge. The wounds weretreated with local irrigation using normal saline,and metronidazole 400 mg was given orally threetimes a day for 5 days until the results of cul-tures were available, and then the antibiotics werechanged accordingly. Only one patient required re-moval of the bicortical screws.

Gram staining and aerobic and anaerobic bacte-rial cultures were done for four patients. A heavygrowth of black-pigmented Bacteroides was re-ported in two cases, a mixed growth of Staphylo-coccus aureus and anaerobes in one case, and nobacterial growth in the fourth case.

4. Discussion

Our study sample was representative of the peoplewho have orthognathic operations with regards tosex and age, the ratios were almost 2:1 and range1847.5 years.17,18

Many reports have established that there is nosignificant difference in the incidence of infectionbetween patients given short-term and long-termantibiotic prophylaxis; Ruggles and Hann19 reported

three cases of postoperative infection in a sampleof 40 patients (8%), all three of which occurredin the short-term group and both during the first2 weeks postoperatively, Bystedt et al.6 reportedan incidence of 6%, and the only postoperative in-fection case occurred in the short-term group. Aprospective, randomised study by Friedrich et al.9

reported an incidence of 7% (2 patients) in thesample of 30 patients with no difference betweenthe two groups. However, a recent randomised,prospective clinical trial by Bentley et al.7 in a sam-ple of 30 patients, reported an incidence of 60% (9


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Antibiotic prophylaxis for orthognathic surgery:a prospective, randomised clinical trial 509

Figure 2. Comparison of scored variables over 6 weeks. The light hatched columns indicate the long-term group, andthe dark-hatched columns the short-term group.

patients) in the short-term and 7% (1 patient) in thelong-term groups occurring after a range of 728days postoperatively.

We compared the efficacy of two regimens us-ing a detailed qualitative/quantitative protocol forregistering infection, we used a number of mark-ers and given them scores, patients who had onlyperioperative doses of antibiotics had increased fi-nal total scores for adverse features (swelling, pain,erythema, etc.). They also had more swelling com-pared to those given long-term antibiotics. The dif-ference in swelling scores was significant from thethird postoperative review (P< 0.05), and this pat-tern was noticed in all the subsequent visits (fourthto seventh visit) except for the sixth one (Figure 1).There were no significant differences in other vari-ables in the scoring system. However, the data fromthis study showed that six patients required differ-

ent or additional antibiotics in the postoperativeperiod, 4/17 in one group and 2/17 in the other,and this difference is not statistically significant.Therefore, the criteria we have used to register in-fection are rather indirect indices of infection andcan be attributable to the surgery. When we used aclear endpoint such as additional antibiotics, whatthe average surgeon would call true infection, thenthere was no difference between the groups al-though there was a trend toward a number of ad-verse features being more common in the placebogroup. It was of interest that although swelling was

rated as a minor feature of delayed wound infectionwith scoresof 03 out of a total of 52 it proved to bethe most useful marker. The other variables showedno individual differences between the groups butwere reliable separating measures when added.

The microbiological findings of our study weresimilar to previous studies, for which amoxycillinwould be appropriate.2022 There was no evidencethat the longer term antibiotics predisposed to re-sistant strains.

Acknowledgements

We would like to acknowledge the invaluable ad-vice and support of: Professor Wagner Mercenes forstatistics, Dr. Peter Wilson consultant microbiolo-gist and Ms. Anna Lam.

References

1. Finlay PM, Atkinson JM, Moos KF. Orthognathic surgery: pa-tient expectations; psychological profile and satisfactionwith outcome. Br J Oral Maxfac Surg 1995;33:914.

2. Flynn NM, Lawrence RM. Antimicrobial prophylaxis. MedClin North Am 1979;63:122544.

3. Peterson L. Antibiotic prophylaxis against wound infectionsin oral and maxillofacial surgery. J Oral Maxillofac Surg1990;48:61720.

4. Gallagher DM, Epker B. Infection following intraoral surgi-cal correction of dentofacial deformities: a review of 140consecutive cases. J Oral Surg 1980;38:11720.


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5. Conover MA, Kaban LB, Mulliken JB. Antibiotic prophylaxisfor major maxillocranialfacial surgery. J Oral MaxillofacSurg 1985;43:8659.

6. Bystedt H, Josefsson K, Nord C. Ecological effects of peni-cillin prophylaxis for orthognathic surgery. Int J Oral Max-illofac Surg 1987;16:55965.

7. Bentley K, Head T, Aiello G. Antibiotic prophylaxis in or-thognathic surgery: a 1-day versus 5-day regimen. J Oral

Maxillofac Surg 1999;57:22630.8. Heit J, Farhood V, Edwards R. Survey of antibiotic prophy-

laxis for intraoral orthognathic surgery. J Oral MaxillofacSurg 1991;49:3402.

9. Friedrich K, Patrony B, Zeitler D. Prospective analysis ofantibiotic prophylaxis for orthognathic surgery. Int J AdultOrthod Orthognath Surgery 1994;9:12931.

10. Zijderveld SA, Smeele LE, Kostene PJ, Tuinzing DB. Pre-operative antibiotic prophylaxis in orthognathic surgery: arandomized, double blinded and placebo-controlled clinicalstudy. J Oral Maxillofac Surg 1999;57:14037.

11. Yrastorza JA. Indications for antibiotics in orthognathicsurgery. J Oral Surg 1976;34:5146.

12. Peterson L, Booth D. Efficacy of antibiotic prophylaxis in in-traoral orthognathic surgery. J Oral Surg 1976;34:108891.

13. Wilson APR, Treasure T, Sturridge MF, Gruneburg RN. A scor-ing method (ASEPSIS) for postoperative wound infectionsfor use in clinical trials of antibiotic prophylaxis. Lancet1986;i:3113.

HISTORICAL CASE

JAMES RUTHERFORD MORISON(18531939)

British ENT surgeon. Inventor of BIPP paste.Rutherford Morison learned much of his sur-gical practice during the early antiseptic era.Indeed, Joseph Lister was in charge of a neigh-bouring ward. He spent several years in gen-eral practice in Hartlepool (from 1879), wherehe became Medical Officer of Health and physi-

cian to the local hospital. In 1888, he moved toNewcastle-upon-Tyne. After opposition fromcolleagues, he was appointed Professor ofSurgery at the University of Durham in 1910.During his time at Durham, he invented BIPP(bismuth, iodoform, paraffin paste), whichwas widely in war wounds as well as in ENTand oral and maxillofacial surgery. He was akeen researcher and educationalist, and re-tired in 1914 to a rural farm.

14. Garner JS, Jarvis WR, Emori TG, Horan TC, Hughes JM. CDCdefinitions for nosocomial infections. Am J Infect Control1991;85:81827.

15. Peel ALG, Taylor EW. Proposed definitions for the audit ofpostoperative infection: a discussion paper. Ann R Coll SurgEngl 1991;73:3858.

16. Wilson APR. Surveillance of wound infections. J Hosp Infect1995;29:816.

17. Martis C, Karabouta I. Infection after orthognathic surgery,with and without preventive antibiotics. Int J Oral Surg1984;13:4904.

18. Manor Y, Chaushu G, Taicher S, Booth PW. Risk fac-tors contributing to symptomatic plate removal in orthog-nathic surgery patients. J Oral Maxillofac Surg 1999;57:67982.

19. Ruggles J, Hann J. Antibiotic prophylaxis in intraoralorthognathic surgery. J Oral Maxillofac Surg 1984;42:797801.

20. Von Konow L, Nord CE, Nordenarm A. Anaerobic bacte-ria in dentoalveolar infections. Int J Oral Surg 1981;10:31322.

21. Heimdahl A, Von Konow L, Satoh T, Nord CE. Clinicalappearance of orofacial infections of odontogenic originin relation to microbiological findings. J Clin Microbiol1985;22:299302.

22. Topiazan RG, Goldberg MH. Oral and maxillofacial infec-tions. WB Saunders: Philadelphia; 1994 p. 16097.

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