Act a Ot orrinolaringol Esp.

2010;61(1):54-68
ÓRGANO OFICIAL DE LA SOCIEDAD ESPAÑOLA DE OTORRINOLARINGOLOGÍA Y PATOLOGÍA CÉRVICOFACIAL
Y DE LA ACADEMIA IBEROAMERICANA DE OTORRINOLARINGOLOGÍA

SEORL PCF

Acta Otorrinolaringológica Española Enero-Febrero 2010. Vol. 61. Núm. 1

Parotidectomías en tumores benignos: clasificación «Sant Pau»

de la extensión de la resección
Resección de tumor de cuerpo carotideo con LigaSure
Laringectomía horizontal supraglótica láser CO : nuestra
experiencia en seis años
Estudio comparativo mediante tomografía computarizada de
la morfología de la sutura timpanoescamosa entre
colesteatoma atical y oídos sanos
Tensores del velo del paladar y del martillo: vínculos anatómicos,
funcionales y sintomáticos
Los patrones normal y vestibular en la posturografía dinámica
de pacientes con enfermedad de Menière
Epidemiología de las epistaxis ingresadas en un hospital
de tercer nivel
Mucormicosis rinoorbitocerebral, un estudio retrospectivo de 7 casos
Profilaxis antibiótica en cirugía otorrinolaringológica
Recomendaciones de la Comisión para la Detección Precoz
de la Hipoacusia (CODEPEH) para 2010
Fallo barorreceptor tras la resección bilateral de

www.elsevier.es/ ot orrino
paragangliomas carotídeos
Miositis fulminante del compartimento muscular cervical posterior. Full English text available
A propósito de un caso Incluida en:
Síndrome de sonda nasogástrica: MEDLINE/Index Medicus
a propósito de un caso EMBASE/Excerpta Medica
Concerlit, Aidsline
Tiroides lingual: un hallazgo casual Bibliomed, Biosis,
Healfnstar, IBECS

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REVIEW

Antibiotic prophylaxis in otolaryngologic surgery

Sergio Obeso,* Juan P. Rodrigo, Rafael Sánchez, Fernando López, Juan P. Díaz,
and Carlos Suárez

Servicio de Ot orrinolaringología, Hospit al Universit ario Cent ral de Ast urias, Inst it ut o Universit ario de Oncología
del Principado de Ast urias (IUOPA), Oviedo, Spain

Received November 20, 2008; accept ed December 22, 2009

Available online Sept ember 5, 2009

KEYWORDS Abstract
Surgical infect ion; Since the beginning of the 80s, numerous clinical trials have shown a signiicant reduction in the
Ant ibiot ic prophylaxis; i nci dence of i nf ect i ons i n cl ean-cont ami nat ed upper r espi r at or y t r act sur ger y, due t o
Ot olaryngologic perioperat ive use of ant ibiot ics; however, t here is no consensus about t he best ant ibiot ic
Surgery protocol. Moreover, there are no universally accepted guidelines about lap reconstructive
procedures. In ot ologic and rhinologic surgery, t onsillect omy, cochlear implant and laryngo-
pharyngeal laser surgery, t he use of ant ibiot ics frequent ly depends on inst it ut ional or personal
pref erences rat her t han t he evidence avail abl e. We reviewed cl inical t rial s on dif f erent
ot orhinol aryngol ogic procedures, assessing choice of ant ibiot ic, l engt h of t reat ment and
administ rat ion rout e. There are no clinical t rials for laryngo-pharyngeal laser surgery. Nor are
t here clinical t rials on implant cochlear surgery or neurosurgical clean-cont aminat ed procedures,
but in t hese circumst ances, ant ibiot ic prophylaxis is recommended.
© 2009 Elsevier España, S.L. All right s reserved.

PALABRAS CLAVE Proilaxis antibiótica en cirugía otorrinolaringológica

Infección quirúrgica;
Proilaxis antibiótica;
Cirugía
ot orrinolaringológica
Resumen
Desde principios de los años ochent a, numerosos ensayos clínicos han demost rado una reducción
signiicativa en la incidencia de infección en la cirugía limpia-contaminada de la vía aerodiges-
t iva superior debido al uso de ant ibiót icos; sin embargo, no hay consenso sobre las paut as idó-
neas. Tampoco exist e una paut a universalment e acept ada en la reconst rucción con colgaj os. En
la cirugía ot ológica, la rinológica, la amigdalect omía, la implant ación coclear y la cirugía láser
laringofaríngea, el uso de ant ibiót icos perioperat orios depende frecuent ement e de preferencias
personales e inst it ucionales, y no de la evidencia exist ent e. Revisamos de forma crít ica los en-

*Corresponding aut hor.

E-mail address: sergioobeso@yahoo.es (S. Obeso).

0001-6519/ $ - see front mat t er © 2009 Elsevier España, S.L. All right s reserved.
Ant ibiot ic prophylaxis in ot olaryngologic surgery 55

sayos clínicos disponibles sobre diversas t écnicas quirúrgicas ot orrinolaringológicas, evaluando

dist int os ant ibiót icos, duración del t rat amient o o vía de administ ración. No exist en ensayos
clínicos sobre la cirugía láser laringofaríngea. Tampoco hay ensayos clínicos sobre implant ación
coclear y los procedimient os neuroquirúrgicos limpios-cont aminados, si bien en est os supuest os
se recomienda la proilaxis antibiótica.
© 2009 Elsevier España, S.L. Todos los derechos reservados.

Introduction of infection is estimated to be between 24% and 87%.8

Surgical antibiotic prophylaxis is deined as the administration
of an ant imicrobial agent prior t o cont aminat ion in
previously sterile spaces and luids.1 Depending on t he
degree of cont aminat ion and t he risk of infect ion, surgical
wounds are classiied into several categories; we accept the
classiication of the American National Academy of Science
and t he Nat ional Research, as amended by t he American
Societ y of Healt h-Syst em Pharmacist 19992,3:
• Clean inj uries: no opening of respirat ory or digest ive
t ract , no prior infect ion and no violat ion of asepsis.
• Clean-cont aminat ed inj uries: opening of digest ive or
respirat ory t ract , minor violat ion of asept ic t echnique,
closed t rauma or clean surgical reint ervent ion wit hin t he
irst 7 days.
• Cont aminat ed inj uries: clean-cont aminat ed surgery wit h
non-purulent inlammation, greater violation of aseptic
technique and irst 4 h of open trauma.
• Dirty injuries: purulent inlammation, perforation of
hollow viscera or open t rauma for more t han 4 h of
evolut ion.
We have decided t o apply t o our review t he levels
evidence proposed by t he American College of Cardiology
and American Heart Associat ion4 (Table 1). In our view, it
is a simple classiication that stratiies the quality of the
available evidence in a well-deined form.
The incidence of infect ion in clean surgery of head and
neck is est imat ed at less t han 5% and in some series it
reaches igures of 0.56%.5,6 There are no randomised clinical
trials (RCTs) showing the beneit of the use of prophylactic
ant ibiot ics in clean surgery of t he head and neck. Three
retrospective cohort studies found no statistically signiicant
relat ionship bet ween t he decrease in t he incidence of
infect ions and t he use of prophylact ic ant ibiot ics. 5-7 Given
t he low incidence of infect ion, t he design of an RCT would
require a large sample size t o reduce t he error by having
enough st at ist ical power.
In bot h dirt y and cont aminat ed surgery, it is assumed
t hat t he wound is already infect ed and, in t hat case, t he
ant ibiot ic is administ ered wit h t herapeut ic int ent . In clean-
cont aminat ed surgery of t he head and neck, t he incidence
There are numerous, well designed double-blind RCTs, as
well as meta-analysis, that demonstrate the beneit of
perioperat ive prophylact ic ant ibiot ic regimes in reducing
t he incidence of post operat ive infect ion9-14 (evidence level
A). Table 2 shows t he charact erist ics of some of t hese t rials.
In prospect ive st udies using prophylact ic ant ibiot ics in t his
t ype of surgery, t he incidence of infect ion is bet ween 10
and 25%. 15,16 According t o t he American Societ y of Healt h-
Syst em Pharmacist 1999 guideline (ASHP 1999), 3 t he ideal
ant ibiot ic should be act ive against t he most common
cont aminant s, and must be maint ained at appropriat e doses
for t he durat ion of t he cont aminat ion, have a good safet y
proile and be administered in the shortest possible time.
Prophylaxis in clean-contaminated surgery
of the head and neck
Resident germs
The most common pharyngeal colonizers are gram-posit ive
cocci, mainly Pept ost rept ococcus and Pept ococcus species,
and anaerobic germs3,8: in t he oropharynx, t he presence of
anaerobes is 10 t imes more frequent t han t hat of aerobes. 17
Gram-negat ive germs are rare in t he secret ions of healt hy
individuals; nevert heless, germs such as Klebsiella,
Pseudomonas, Prot eus and some Bact eroides species (ot her
t han B. f ragilis) are common colonizers of t he aerodigest ive
t ract of oncology pat ient s. 8
The presence of St rept ococcus and St aphylycoccus is
common in t he nasal cavit y, and t o a lesser ext ent t han
anaerobes. Anaerobes are 10 t imes more numerous in t he
oropharynx t han in t he nasal cavit y. Bet ween 18 and 50%
of healt hy adult s are carriers of St aphylococcus in t heir
nasal fossa; it is est imat ed t hat 0.84%of t he populat ion are
carriers of S. aureus resist ant t o met hicillin (MRSA) in t heir
nasal fossa. 18,19
The presence of gram-negat ive germs is common in t he
isolat ions performed in post operat ive cervical infect ions. 20
However, it is unclear whet her t hey are infect ious agent s
or colonizers. In a clinical t rial, Johnson et al. found no
signiicant differences using a prophylactic regime with

Table 1 Levels of evidence applied in t he review4

Level of evidence A Dat a derived from mult iple randomised clinical t rials or met a-analyses
Level of evidence B Dat a derived from a randomised clinical t rial or nonrandomised st udies
Level of evidence C Dat a derived from consensus of expert s or series of cases
56 S. Obeso et al

Table 2 Double-blind clinical t rials evaluat ing t he use of prophylact ic ant ibiot ics in clean-cont aminat ed surgery of t he head
and neck

Year Aut hor Pat ient s, Ant ibiot ic Durat ion Infect iona P
No.

1962 Ket chman9 20 Chloramphenicol 10 days 18%versus 0% <.05b

1973 Dor10 102 Ampicillin and cloxacillin 5 days 36% versus 17% <.05
1979 Becker11 55 Cefazolin 1 day 87% versus 38% <.001b
1984 Johnson26 16 Cefoperazone 1 day 78% versus 0% <.05
1984 Mandell-Brown12 101 Cefazolin/ cefoperazone/ cefot axime 1 day 33%/ 10%/ 10% <.05
versus 78%
1988 Saginur 13 20 Cefamandole 1 day 55%versus 33% <.05b
a
Incidence bet ween t reat ment group and cont rol group.
b
Int errupt ed t rials in int ermediat e analysis by excessive difference of infect ion bet ween one group and t he ot her.

coverage against gram-posit ive and gram-negat ive germs
compared wit h one t hat covered only gram-posit ive
germs. 21 Nor were there signiicant differences with regards
t o coverage or not of gram-negat ives in t he clinical t rials of
Rodrigo et al. 15 and Piccart et al. 22
Isolat ion of bact eria in infect ed surgical wounds of
clean-cont aminat ed head and neck surgery commonly has
polymicrobial charact erist ics; depending on t he series,
t his ranges bet ween 38 and 95% of isolat ions. 15,20,23-25 The
isolat ion of gram-posit ives is more frequent , followed
by gram-negat ives and anaerobes. 15,23 In most series, t he
isolat ion of anaerobic bact eria is less frequent t han t hat of
aerobic, except for t he series of Johnson et al., in which it
reaches up t o 42%of isolat es in pat ient s who did not receive
ant ibiot ic prophylaxis. 26 Moreover, it must be considered t hat
t he isolat ion of anaerobes is more complicat ed t han t hat of
aerobes, so t heir presence may be underest imat ed. There
are risk fact ors t hat favour t he presence of anaerobes in t he
infect ious focus, such as concomit ant dent al ext ract ions27
and surgery of t he oral cavit y. 17
There is lit t le correlat ion bet ween t he result s of
preoperat ive cult ures of t he aerodigest ive t ract and t he
post operat ive infect ious agent . In a review by Suarez et
al., only in 44% of cases was it possible t o ident ify t he
post operat ive pat hogen in t his manner. 8,28 The correlat ion
bet ween microorganisms isolat ed from post operat ive
drainage and t he agent isolat ed from t he infect ion ranges
bet ween 38% and 54%. 8 Only one st udy found a correlat ion
of 100%. 29
Recommended guidelines
Choice of antibiotic
Hist orically, and st ill t oday, various prophylact ic regimes are
used depending on t he inst it ut ion and personal experience.
The most commonly used ant ibiot ics include cephalosporins,
amoxicillin or ampicillin, clindamycin, met ronidazole,
aminoglycosides, and various combinat ions t hereof. 30 Table
3 det ails various charact erist ics of several widely used
ant ibiot ics in surgery of t he head and neck. 31,32
The beneit of employing regimes including clindamycin
plus an aminoglycoside versus clindamycin alone has not
been shown in well-designed RCTs; nevert heless, one of
t hose clinical t rials (Piccart et al.) was not complet ely
cont rolled. 21,22 Furt hermore, several double-blind RCTs
have not shown with statistical signiicance the beneit of
t he use of clindamycin and gent amicin versus cefazolin or
amoxicillin-clavulanat e. Skit arelic et al., on 189 pat ient s
undergoing clean-cont aminat ed surgery of t he head and
neck, excluding free laps, found no statistically signiicant
reduct ion in t he incidence of infect ion bet ween amoxicillin-
clavulanat e and cefazolin. 20 Rodrigo et al., in RCTs of 159
patients, not including free laps, who were split into three
groups, found no statistically signiicant differences in terms
of infect ion bet ween amoxicillin-clavulanat e, cefazolin and
clindamycin + gent amicin. 15 The main differences bet ween
cefazolin and amoxicillin-clavulanat e are coverage against
anaerobes and t he resist ance against bet a-lact amase of
amoxicillin-clavulanat e. Wit h regard t o t he need for t he
use of bet a-lact amase-resist ant ant ibiot ics, in an RCT on
118 pat ient s t hat compared cefazolin sensit ive t o bet a-
lact amase versus moxalact am resist ant t o bet a-lact amase,
there were no signiicant differences.33 Table 4 det ails
t he charact erist ics of various RCTs evaluat ing different
prophylact ic ant ibiot ic regimes.
There is a single blind RCT wit h four groups and 120
participants where lower infection is signiicant in the
groups including met ronidazole. However, in t hat t est ,
in which combinat ions of ant ibiot ics were administ ered,
met ronidazole and gent amicin were administ ered by
inj ect ion, whereas cephalexin and ampicillin were
administ ered orally in t he post operat ive period. 34
For all t hese reasons and considering t hat cefazolin is a
cheaper ant ibiot ic, wit h a lesser spect rum and safer t han
amoxicillin-clavulanat e, clindamycin, or aminoglycosides,
then cefazolin is recommended as irst choice for surgical
prophylaxis in clean-cont aminat ed surgery of t he head
and neck, according t o t he recommendat ions of t he
Antibiotic prophylaxis in otolaryngologic surgery 57

Table 3 Ant ibiot ics used for prophylaxis in clean-cont aminat ed surgery of t he head and neck31,32

Bact erial coverage Adverse effect s Dosagea Cost b

Clindamycin Anaero bic Gram-posit ives GI int olerance, pseudomembranous 300-900 mg/ 6-8 h 11.5
colit is, hepat ot oxicit y, cyt openia
Gentamicin Gram-negative aerobes, Nephrotoxicity, ototoxicity, 5-7 mg/kg/day 1.8
S. aureus neuromuscular blockade in 1-2 doses
Amoxicillin- Gram-posit ives, Anaphylaxis, gast roint est inal 1-2 g amoxicillin+ 11.5
clavulanat e gram-negat ives, int olerance, superinfect ion 200 mg clavulanat e
Ent erococci, anaerobes / 6-8 h
Ampicillin- Similar t o amoxicillin- Similar t o amoxicillin-clavulanat e 1-2 g ampicillin+ 4
sulbact am clavulanat e 500 mg sulbact am/
6-8 h
Cefazolin Gram-posit ive cocci Anaphylaxis, GI int olerance 1-2 g/ 6-8 h 9
Vancomycin Gram-posit ive aerobes, Nephrot oxicit y, ot ot oxicit y, 20-50 mg/ kg/ day 34.5
gram-posit ive anaerobes, red man syndrome, phlebit is in 2 doses
Clost ridium
Metronidazole Gram-positive cocci, Gastrointestinal toxicity, 250-750 mg/kg/ 11.5
anaerobes met allic t ast e, polyneuropat hy, 8-12 h
dizziness
a
Dose for an adult .
b
Euros/ day of t reat ment , t aking as reference generic drugs.

Table 4 Clinical t rials evaluat ing different ant ibiot ics in clean-cont aminat ed surgery of t he head and neck

Year Aut hor Pat ient s Ant ibiot ic Infect ion, % P

1986 Johnson33 118 Moxalact am 3.40 >.05

Cefazolin 8.50
1987 Johnson21 104 Clindamycin 3.80 >.05
Clindamycin and gent amicin 3.80
1997 Rodrigo15 159 Amoxicillin-clavulanat e 23 .8
Clindamycin and gent amicin 21
Cefazolin 26
2007 Skitarelic20 189 Cefazolin 24 >.05
Amoxicillin-clavulanat e 21

Ant imicrobial Agent s Commit t ee of t he Surgical Infect ions
Societ y and ASHP 1999. Clindamycin should be reserved for
cases of allergy t o bet a-lact ams. In t he absence of RCTs
evaluating the eficacy of regimes against anaerobes in
pat ient s at risk versus pat t erns wit hout such coverage, it
is postulated that amoxicillin-clavulanate could be the irst
choice in surgeries at risk of cont aminat ion by anaerobes,
such as oral or oropharyngeal surgery or concomit ant t oot h
ext ract ions.
Recommended doses
a higher incidence of infect ion in t he group t reat ed wit h
500 mg of cefazolin versus clindamycin wit h gent amicin
(33% vs 7%) was signiicant.36 In an RCT by Mendell-Brown,
which is hampered by low sample size, t he administ rat ion
of 500 mg of cefazolin resulted signiicantly less effective
t han cefoperazone or cefot axime. 12 On t he ot her hand,
in a double-blind RCT wit h over 100 part icipant s, using
perioperative cefazolin in doses of 2 g, the signiicant beneit
of ot her ant ibiot ic regimes was not demonst rat ed. 15,33
According t o ASHP 1999 and by virt ue of t he above, doses
of 2 g of cefazolin are recommended; t he alt ernat ive would
be 600 mg of clindamycin. 3

In one RCT by Robbins et al. on 218 pat ient s, which

compared 500 mg of cefazolin versus t he same dose of Duration of the prophylaxis
cefazolin with metronidazole, a statistically signiicant
incidence of infect ion of 23.9% and 11.9%, respect ively, Theoret ically, once t he mucosa of t he cont aminat ed viscera
was found. 35 In an RCT by Johnson et al. on 50 pat ient s, has closed, t he source of cont aminat ion has ceased and t he
58
administ rat ion of ant ibiot ics ceases t o have a t heoret ical
basis. If t here is any suspicion about t he loss of t ight ness of
t he compart ment , t hen it is assumed t o be dirt y surgery and
t he ant ibiot ic will have a t herapeut ic int ent . Righi et al. 37
consider t hat post operat ive infect ion produced in a differed
manner cannot be considered failure of prophylaxis, but is
inst ead due t o persist ent cont aminat ion by saliva and is
at t ribut able t o surgical errors, t issue ischemia, abnormal
scarring, et c.
In an experiment al model of surgical infect ion in guinea
pigs, it was found t hat concomit ant administ rat ion of
ant ibiot ics prior t o incision reduced t he incidence of
infect ion. However, t he administ rat ion of ant ibiot ics wit h
a lat ency of 3h was associat ed t o an incidence of infect ion
similar t o t hat of t he group wit hout ant ibiot ics. 38
Johnson et al., 36 in RCTs wit h 56 pat ient s, found no
statistically signiicant differences between administering
clindamycin and gentamicin for 1 day (7% infections) or
5 days (4% infect ions). Piccart et al., 22 in RCTs wit h 140
patients, found no signiicant differences between batches
of carbenicillin for 1 or 5 days. In a more recent clinical
t rial by Righi et al. 37 on 162 pat ient s, excluding free and
pedicled laps, no signiicant differences were found
bet ween administ ering ant ibiot ics for 1 or 3 days.
In t he absence of favourable evidence for t he use of long
prophylact ic regimes, it is recommended t hat prophylaxis
should not exceed 24h. Long regimes imply higher cost s, more
risk of adverse side effect s and t he risk of superinfect ion.
It should be not ed t hat , as t he difference bet ween long and
short regimes is slight , it would require a large sample size
to ind signiicant differences. There is a correlation study39
wit h a level of evidence C in which, on 258 pat ient s, an
odds rat io (OR) of 1.89 was found for infect ion occurring in
pat ient s t reat ed wit h long regimes.
According t o t he above, a dose of 2 g of cefazolin prior t o
incision, followed by 2 g i.v. every 8 h for 24 h, is recommended
as a prophylact ic regime for clean-cont aminat ed surgery of
t he head and neck. An alt ernat ive regime recommended
is 600 mg i.v. clindamycin before incision, followed by
600 mg every 8h for 24h. This pat t ern coincides wit h
t hat recommended by ASHP 1999, but differs from t hat
recommended by t he American Academy of Ot olaryngology-
Head and Neck Surgery (AAOHNS) in t he eight h edit ion of it s
ant imicrobial guide, 40 which recommends clindamycin and
gentamicin or ceftazidime as a irst choice. When there is
a risk of infect ion by anaerobes, t he AAOHNS recommends
alt ernat ive regimes, such as ampicillin-sulbact am or
cefazolin with metronidazole. Although there is no scientiic
evidence, we recommend amoxicillin-clavulanat e if t here is
a risk of cont aminat ion by anaerobes; t hat is, in oral and
oropharyngeal surgery or when performing concomit ant
dent al ext ract ions. 3,40
Role of topical antibiotics
Topical preoperat ive washing wit h ant ibiot ics or ant isept ics
and irrigation of the surgical ield prior to closure are
both considered as topical prophylaxis. They do not it the
given deinition of antibiotic prophylaxis. The preoperative
washing seeks t o reduce t he concent rat ion of t he inoculum,
while the irrigation of the ield assumes that the wound
S. Obeso et al
has already been cont aminat ed. It s effect iveness has been
demonst rat ed in colorect al surgery, but t here are few
st udies on head and neck surgery. 41
The maj or source of bact eria is locat ed on t he t ongue
and t o a lesser ext ent in t he t eet h and gums; t herefore,
toothbrushing does not afford suficient prevention.42 The
bact erial concent rat ion in saliva is higher in t he morning
and decreases wit h food int ake, oral washings and
t oot hbrushing.
Experiment al st udies in guinea pigs inoculat ed wit h
S. aureus have shown t hat adj uvant syst emic ant ibiot ic
treatment with topical antibiotic increases eficacy.43
Ot her st udies suggest t hat highly cont aminat ed wounds
are those that beneit most from the administration of
topical antibiotics, which provide no beneit in scarcely
cont aminat ed wounds. 44 Moreover, regression analysis has
identiied the presence of colony forming units (cfu) in the
neck at t he t ime of closure as t he foremost risk fact or for
infect ion. 45
In t he t ime before t he rout ine use of prophylact ic
syst emic ant ibiot ics, in 22 randomised pat ient s undergoing
t ot al laryngect omy, it was proven t hat washing t he wound
with topical ampicillin and carbenicillin signiicantly
reduced infection, from 67% in the control group to 18% in
t he group wit h washings46 (level of evidence B). In a pilot
st udy on 20 pat ient s undergoing t ot al laryngect omy, a lower
cfu concent rat ion was found in t he neck of pat ient s who
underwent t opical wound washing and preoperat ive rinsing
wit h bet a-lact ams, versus int ravenous clindamycin. 47 There
are no RCTs which demonstrate the beneit of combining
washings of t he wound wit h ant ibiot ics and syst emic
prophylaxis versus syst emic prophylaxis alone.
Oral cult ure st udies in healt hy adult s have shown
t hat oral washes wit h clindamycin produced a 4-hour
reduct ion in t he concent rat ion of aerobic cf u t hat was
signiicant and of anaerobic cfu that was not signiicant.42
In t he st udy by Kirchner et al. , 48 the drag effect of luids
explains t hat washings wit h placebo diminished cf u in
saliva; however, t he cf u reduct ion in t he group t reat ed
wit h oral clindamycin washes was 14% f or aerobes and
11%f or anaerobes af t er 4h, whereas in t he placebo group
the reduction was 67% and 95%, respectively. Parenteral
clindamycin reduces cf u in t he wound, but not in saliva. 47
On healt hy volunt eers, t he reduct ion of bact erial
concent rat ion in saliva wit h preoperat ive washings using
amoxicillin-clavulanat e, clindamycin and povidone was
signiicant when compared with placebo. 49 Washing wit h
amoxicillin-clavulanat e is more ef f ect ive, but did not
reach statistical signiicance.
In a prospect ive st udy wit h one group of 10 pat ient s who
underwent t ot al laryngect omy wit hout syst emic ant ibiot ic
prophylaxis, t he administ rat ion of t opical clindamycin in
t he form of preoperat ive washing reduced by 99%t he cfu in
t he wound at t he t ime of closure wit h respect t o previous
oral cult ures; t opical washing reduced cfu concent rat ion in
t he neck by an addit ional 90%. 50 The most comprehensive
st udy in t his regard is t he prospect ive randomised clinical
t rial of Redleaf et al. 51 on 106 pat ient s undergoing clean-
cont aminat ed oral or oropharyngeal surgery. The group wit h
t opical ant isept ic wash prior t o surgery showed an incidence
of infect ion of 4.6%, while t he incidence in t he group wit hout
washing stood at 31.7% (P<.01). However, t hat st udy was
Ant ibiot ic prophylaxis in ot olaryngologic surgery
not complet ely cont rolled; almost all received syst emic
antibiotic, but it was not speciied whether the distribution
was homogeneous in bot h groups. Wit h t he except ion of
that study, there are no RCTs that demonstrate the beneit
of prior washing wit h t opical ant ibiot ics.
Antibiotic prophylaxis in laps
There is controversy over whether reconstruction with laps
is associat ed wit h an increased rat e of infect ion; t here
is also discussion about what kind of lap is associated
wit h an increased risk of infect ion. In one RCT on oral or
oropharyngeal surgery, no statistically signiicant difference
was found bet ween direct closure and reconst ruct ion wit h
free lap. In that same study, it is signiicant that direct
closures become infected less often than pedicled laps.51
Other studies have found no signiicant difference between
direct closure and pedicled laps,15 and in t he ret rospect ive
st udy of Girod et al., 52 reconstruction with laps was
associat ed wit h a higher rat e of complicat ions, but not
of infect ions (P<.05). However, most st udies est imat e an
increased incidence of infection with the use of laps (20%-
25%) versus direct closure (5-10%). 53 Loti et al.39 found an
increase of 2.2%in t he risk of infect ion in t he reconst ruct ion
with laps and several studies indicate that primary closure
has a bet t er evolut ion. 54,55
Different ant ibiot ics are not recommended in t he case of
closure with laps. It has been speculated that clindamycin
prot ect s from t issue necrosis associat ed wit h infect ion.
However, in a RCT of 100 cancer pat ient s undergoing
oncologic reconstruction with laps, no signiicant
differences were found bet ween clindamycin and cefazolin
(19.6%compared t o 21.6%; P>.05). 56
The main issue discussed wast he need for longer prophylaxis
regimes. In double-blind RCT on 109 pat ient s undergoing
reconstruction with pedicled laps, no signiicant difference
was found bet ween t he administ rat ions of cefoperazone for
1 or 5 days. 57 In fact , in t hat st udy, infect ion in t he 5-day
group was more common (25% versus 18.9%). In anot her
single-blind RCT on 74 patients with reconstructions using
free laps, there were no signiicant differences between
t he 1-day and 5-day clindamycin regimes. 58 In t he st udy by
Simons et al. 53 on 62 pat ient s undergoing reconst ruct ion
with free and pedicled laps, no beneit was found in adding
t opical piperacillin t o t he syst emic prophylact ic t reat ment
for 2 days wit h piperacillin/ t azobact am.
In short , t he few published RCTs have not proven t he
beneit of clindamycin over cefazolin or a lower rate of
infect ion wit h long ant ibiot ic regimes or wit h t opical
ant ibiot ic. The use of long regimes is support ed by t he
suspicion of a loss of sealing, in which case t he int ent ion
is t herapeut ic.
Antibiotic prophylaxis in special situations
Antibiotic prophylaxis in laser surgery
Laser surgery of t he upper aerodigest ive t ract may be
followed by perichondrit is and chondronecrosis, as well
as by visceral perforat ion. The t reat ment of choice for
59
perichondrit is is t he administ rat ion of syst emic ant ibiot ics
such as clindamycin, which t he cart ilage absorbs wit h great
avidit y, t oget her wit h debridement of affect ed areas. 59
In a prospective study of 275 patients undergoing laser
resect ion of t umours of t he larynx and hypopharynx, t he
appearance of perichondritis was found in 0.72% of patients;
t he affect ed pat ient s had undergone resect ions wit h wide
exposure of t he t hyroid cart ilage. 60 St udies on ret rospect ive
series reach an incidence of perichondrit is of 0.8%. 61
In a ret rospect ive series of pat ient s t reat ed t hrough
CO2 laser resect ion of malignant lesions at t he level of
t he upper aerodigest ive t ract , no case of perichondrit is
was found in 337 patients with glottic T1. In patients
with glottic T2b, perichondritis was found in 1.7% of
115 pat ient s and in 1.1% of t hose wit h glot t ic T3. In 216
pat ient s wit h supraglot t ic carcinoma, t here were no cases
of perichondritis, nor were there any in 174 patients with
carcinomas of t he pyrif orm sinus. 59 There are no RCTs t hat
examine t he relat ionship bet ween t he use of ant ibiot ics and
a reduct ion in t he incidence of perichondrit is. However,
because t his is a rare phenomenon, a large sample size
would be required to show statistical signiicance. There
are also no randomised st udies t hat demonst rat e t he
usef ulness of ant ibiot ics in t he endoscopic t reat ment of
Zenker’s divert iculum. Van Overbeek, 62 in a ret rospect ive
analysis of 216 pat ient s t reat ed wit h CO2 laser who were
receiving ant ibiot ic once a week, showed an incidence of
mediast init is of 2.4%, and of subcut aneous emphysema of
3.2%. A ret rospect ive series63 of 61 pat ient s, of whom 92%
received prophylact ic cef uroxime, revealed a perf orat ion
rat e of 8%.
Due t o t he lack of conclusive st udies, t he use of ant ibiot ics
is not recommended in laser surgery of t he larynx or
hypopharynx or in t he endoscopic t reat ment of Zenker’s
divert iculum.
Antibiotic prophylaxis in rhinologic surgery
Healt hy individuals have pot ent ially pat hogenic species in
t heir nost rils such as S. aureus, Klebsiella sp. or Escherichia
coli in 77% of cases.64 Bet ween 18%and 50%of pat ient s are
colonized by S. aureus. In pat ient s diagnosed wit h chronic
rhinosinusit is, mult iple bat ches of ant ibiot ic t reat ment s
select for resist ant pat hogenic species. Up t o 90%of pat ient s
undergoing endoscopic sinonasal surgery present posit ive
cult ures, and most species are resist ant t o penicillin and
65%are resist ant t o cephalosporines. 65
The risk of bact eraemia wit h nasal packing is est imat ed
at around 12% in pat ient s who have not undergone
surgery. 66 Up t o 15%of pat ient s undergoing sept oplast y and
sept orhinoplast y wit h nasal packing develop bact eraemia. 67
Bact eraemia may lead t o endocardit is in pat ient s at risk by
cardiopat hies, carriers of prost het ic valves, pat ient s wit h
cardiac t ransplant at ion or a hist ory of endocardit is; in t hese
cases, ant ibiot ics are recommended for t he durat ion of t he
bact eraemia. Nevert heless, endocardit is has also been
described in nat ive valves in pat ient s wit h nasal packing. 68
The 2007 clinical guidelines of the American Heart
Associat ion recommend t he use of amoxicillin or ampicillin
as a single dose 30 min before t he mucosal incision; t his
document does not make reference t o bact eraemia
60
associat ed t o nasal packing. 4 There are no RCTs t o
demonst rat e a reduct ion in t he incidence of bact eraemia in
pat ient s wit h nasal packing when using ant ibiot ics. Anot her
of t he infect ious complicat ions ascribed t o t he use of nasal
packing is st aphylococcal t oxic shock syndrome, which is
est imat ed at 16.5/ 100,000 rhinologic int ervent ions. 69 It
has not been shown t hat perioperat ive use of ant ibiot ics is
beneicial in preventing this complication.70
It is est imat ed t hat t he infect ion rat e in sept oplast y is
approximat ely 2.5%. An incidence of infect ion of 0.48%was
det ect ed in a st udy of 1040 sept oplast ies wit h blockage
and wit hout perioperat ive ant ibiot ics. 71 Caniellas et al., 72
in t heir RCT of 35 pat ient s undergoing sept oplast y wit h
packing, found no signiicant differences in pain, morbidity
or complicat ions in pat ient s t reat ed wit h cefazolin during
anaest het ic induct ion, wit h t he ant ibiot ic for 1 week or
wit hout ant ibiot ic. In t he RCT of Manzini et al. 73 on 100
pat ient s undergoing sept oplast y, divided int o four groups
wit h and wit hout ant ibiot ic and wit h and wit hout packing,
there were no signiicant differences with regard to
infection. There are no RCTs that have shown the beneit
of perioperat ive syst emic ant ibiot ics in sept oplast y; nor has
it been demonst rat ed t hat t hey reduce colonizat ion of t he
packing. However, despit e t hese dat a, up t o 66% of U.S.
ot olaryngologist s rout inely use ant ibiot ics in sept oplast ies. 74
In t he UK, it is est imat ed t hat only 22% of hospit als do not
use perioperative antibiotics and 37% use them for more
t han 24 h. 71
Bandhauer et al., 75 in t heir RCT on 95 pat ient s undergoing
septoplasty with parking, found a signiicantly lower growth
of S. aureus and ot her pat hogenic species in t he group
t reat ed wit h single doses of Terra-Cort ril ® on t he packing.
Several RCTs conirm the usefulness of topical antibiotics in
reducing t he colonizat ion of packings. 66,76 The beneits of the
use of Synalar ® on t he packing have been shown in pat ient s
undergoing endoscopic surgery for chronic rhinosinusit is,
signiicantly reducing (by up to 36%) the colonization of
Merocel ®, but no differences were found wit h regard t o
post operat ive rhinorrhea. 66
In complex nasal surgery, underst anding as such review
sept orhinoplast ies, nasal graf t surgery or t he repair of
septal defects, the infection rate reaches 27%.18 It has
been suggested that these patients might beneit from
using ant ibiot ics, but t here are no RCTs comparing t he
perioperat ive use of ant ibiot ics versus placebo. In t he RCT
by Andrews et al. 18 on 164 pat ient s undergoing complex
septorhinoplasty, no signiicant differences in infection
were f ound bet ween t he administ rat ion of syst emic
ant ibiot ics during 1 day vs 3 days. Schaf er et al., 77 in t heir
RCT on 100 pat ient s undergoing complex sept orhinoplast y
wit h packing and t opical ant ibiot ics on t he packing, f ound
8% of inf ect ion in t he group t reat ed f or 12 days wit h
propicillin compared to 27% in the group without systemic
ant ibiot ics.
Based on t he foregoing, we recommend t he use of t opical
ant ibiot ic on t he parking in pat ient s undergoing sept oplast y
and sept orhinoplast y, for t here is no evidence t hat syst emic
antibiotic is beneicial. There is still uncertainty about
t he usefulness of perioperat ive ant ibiot ics in complex
sept orhinoplast ies. Pat ient s wit h packing and at risk for
endocardit is should be t reat ed wit h syst emic ant ibiot ics t o
prevent bact eraemia.
S. Obeso et al
Antibiotic prophylaxis in amygdalectomy
It has been suggest ed t hat colonizat ion by t he oropharyngeal
lora of the open tonsillar fossa produces a local inlammatory
response t hat exacerbat es post operat ive pain. 78 It is widely
accept ed t hat infect ion causes secondary bleeding, while
only 16% of pat ient s wit h bleeding aft er t onsillect omy
present ed posit ive cult uresin t he oropharynx. 79 Furt hermore,
in pat ient s undergoing t onsillect omy, bact eraemia occurs in
40% of cases, wit hout t his being relat ed t o an increased
incidence of fever or discomfort . 80 However, it is import ant
t o prevent bact eraemia in pat ient s at risk for endocardit is.
In a 1955 st udy, 81 t reat ment wit h penicillin-procaine for 4
days in t he post operat ive period in 20 pat ient s undergoing
t onsillect omy was followed by bact eraemia in 5.5% of
cases; however, in t he 68 cont rol pat ient s, t he incidence of
bact eraemia was 28%. For pat ient s at risk for endocardit is,
2 g of amoxicillin 30 min before incision is t he recommended
dose (t he paediat ric dose is 50 mg/ kg); alt ernat ively,
clindamycin is preferred in allergic pat ient s, wit h a dose
of 600 mg. 4
Grandis et al., 82 in an RCT of 101 adult pat ient s, showed
that administration of beta-lactam antibiotics for 7 days
signiicantly reduced the duration of halitosis and the time
of ret urn t o a normal diet and daily act ivit ies. The met a-
analysis of Dhiwakar et al., 83 which included ive RCTs
wit h adult and paediat ric pat ient s, and bot h syst emic
and topical treatments, showed a signiicant reduction in
t he incidence of post operat ive f ever (r=0.62), durat ion of
halit osis (2 days less) and t ime t o ret urn t o normal act ivit ies
(0.64 days less) in t he group t reat ed wit h ant ibiot ics;
t he dif f erences in pain reduct ion, ret urn t o normal diet ,
t he need f or analgesia and secondary bleeding were not
signiicant. Similar results were conirmed in a more
ext ensive met a-analysis by t he same aut hors84; in nine
RCTs, there was a signiicant reduction in the incidence
of f ever (RR=0.63) in t he group t reat ed wit h ant ibiot ics,
but not of pain or secondary bleeding. Neit her was t he
incidence of adverse events signiicant in patients treated
wit h ant ibiot ics. In a t hird met a-analysis, by Burkat et
al. 85 on seven RCTs, t he only paramet ers t hat showed
signiicantly reduced incidence in the group with antibiotic
t reat ment were t he reduct ion of one day in t he ret urn
t o normal diet and ret urn t o normal act ivit y. Considering
t hese dat a (which correspond t o a level of evidence A),
we conclude t hat perioperat ive t reat ment wit h syst emic
ant ibiot ics reduces t he incidence of f ever and halit osis;
t o a lesser degree and in a very subt le manner, it enables
an early ret urn t o habit ual diet and act ivit y. There is no
evidence t hat ant ibiot ics reduce pain and bleeding. It must
be kept in mind t hat t hese st udies mixed paediat ric and
adult populat ions, various ant ibiot ic regimes and various
surgical t echniques.
Telian et al. , 86 in t heir RCT on 100 paediat ric pat ient s
undergoing t onsillect omy, evaluat ed preoperat ive
administ rat ion of int ravenous ampicillin f ollowed by
amoxicillin for 7 days versus placebo. There were
signiicant differences in the incidence of fever, halitosis
(4 days less) and ret urn t ime t o diet (1 day less) and daily
act ivit y (1 day less) in t he group t reat ed wit h ant ibiot ics;
it must be t aken int o account t hat t hat st udy excluded
7 patients from the inal analysis due to postoperative
Ant ibiot ic prophylaxis in ot olaryngologic surgery
inf ect ion (6 in t he group wit hout ant ibiot ics) and t hat
3 of t he pat ient s experienced bleeding (all in t he group
wit hout ant ibiot ics). Pain was not assessed wit h a linear
scale; however, there was a signiicant reduction in the
durat ion of t he painf ul period (3. 3 versus 4. 4 days) in t he
group t reat ed wit h ant ibiot ics. Ramos et al. , 87 in an RCT
on 58 children, found no signiicant differences in terms
of f ever or pain in pat ient s t reat ed wit h amoxicillin-
clavulanat e in t he post operat ive period. In t he met a-
analysis of Lyer et al. , 88 in paediat ric pat ient s undergoing
t onsillect omy, only t he associat ion bet ween short er t ime
unt il ret urn t o normal diet (1 day) and t he perioperat ive
use of antibiotics was signiicant. In a study 89 wit h no
randomisat ion or blinding on paediat ric pat ient s,
signiicantly reduced pain and better oral tolerance were
f ound in t he group t reat ed wit h ant ibiot ics. Paradoxically,
Lee et al. 90 found a signiicantly increased incidence of ear
pain and need for analgesia on the ifth postoperative day
in pat ient s t reat ed wit h amoxicillin f or 5 days. However,
t his was not a blind st udy and f ollow-up was carried out
by t elephone. In t he light of t hese st udies, t here is no
evidence t hat perioperat ive syst emic ant ibiot ics in t he
paediat ric age decrease t he incidence of bleeding and
inf ect ion. The level of evidence is B wit h respect t o t he
reduct ion of t he durat ion of halit osis, f ever and earlier
ret urn t o daily act ivit ies in paediat ric pat ient s t reat ed
wit h ant ibiot ics. The administ rat ion of ant ibiot ics in
paediatric patients signiicantly reduces the early return
t o normal diet (level of evidence A). The regimes most
frequently used in the literature include 5 to 7 days of
t reat ment wit h bet a-lact ams.
While st udies using syst emic ant ibiot ics are numerous,
those that assess the eficacy of topical antibiotics are
scarce. In t he RCT of Mann et al. 78 on adult pat ient s,
t opical t reat ment was assessed bef ore and af t er surgery
wit h bot h clindamycin and amoxicillin versus syst emic
t reat ment wit h amoxicillin f or 1 week and t reat ment wit h
placebo. Pat ient s t reat ed wit h t opical ant ibiot ics had a
signiicantly lower growth of cfu in oral secretions. Odour
and pain were signiicantly lower in patients with topical
ant ibiot ics, but ot algia, f ever, and ret urn t o everyday
act ivit y were not . In an RCT90 on 60 paediat ric pat ient s,
no signiicant difference was found between fusafungine,
f usaf ungine wit h analgesics and amoxicillin-clavulanat e
with analgesics in terms of pain in the irst 10 days;
however, from day 10 the pain was signiicantly less and
scarring was bet t er in t he groups wit h t opical f usaf ungine. 91
There are no more clinical t rials comparing t opical versus
syst emic ant ibiot ic t reat ment . One RCT on 101 pat ient s
over 12 years found signiicant beneit with respect to
t ime t o normal diet in pat ient s receiving oral and t opical
t reat ment versus t he group wit hout t reat ment ; pain and
fever were not signiicantly reduced.82 In one RCT on 68
pat ient s, t he t opical use of f usaf ungine, an ant ibact erial
and anti-inlammatory peptide, reduced pain during the
irst days and also reduced the consumption of analgesics
signiicantly.92 Through all t hese dat a, t here is a B level
of evidence t o recommend t he use of t opical ant ibiot ics
in adult pat ient s undergoing t onsillect omy in t erms of
reduced post operat ive morbidit y, and a level of evidence A
to conclude that systemic antibiotics do not offer beneits
over t opical ant ibiot ics.
61
Antibiotic prophylaxis in otologic surgery
Most ot ologic surgery falls int o t he cat egory of clean surgery.
However, surgery for chronic ot it is media, wit h or wit hout
cholest eat oma, should be considered clean-cont aminat ed; if
t here ot orrhea during surgery, it is considered cont aminat ed
or dirt y, so t he use of ant ibiot ics would have a t herapeut ic
int ent ion. 93
Post operat ive infect ion in ot ology manifest s it self as a
loss of t he neot ympanic graft , labyrint hit is, surgical wound
infect ion or t he occurrence of medial or ext ernal ot it is. In
order t o syst emat ise ot ologic int ervent ions based upon t he
risk of infection, we will take the classiication proposed by
Verschuur et al. 94:
• Clean surgery: myringoplast y, st apedect omy, ossicular
reconst ruct ion and dry ears.
• Clean-cont aminat ed or dirt y surgery: ears wit h
preoperat ive suppurat ion (chronic ot it is media wit h or
wit hout cholest eat oma).
• Insert ion of t ranst ympanic drainage t ubes: ears wit hout
effusion are considered clean; wit h seromucous effusion,
clean-cont aminat ed; and wit h purulent effusion, dirt y.
The incidence of post operat ive inf ect ion in clean
surgery has been est imat ed as less t han 5%, whereas,
it has been estimated as between 7 and 14% for clean-
cont aminat ed surgery. 95-97 The most common inf ect ious
agent s in clean ot ologic surgery are species of S. aur eus
and ot her gram-posit ives. 93 In chronic ot it is media
wit hout cholest eat oma, t he most f requent ly isolat ed
germs are Pseudomonas aer ugi nosa and St aphyl ococci
species, mainly S. aur eus. Dif f erent species of gram-
negat ive organisms f ollow in order of f requency, such
as Kl ebsi el l a, Pr ot eus or Haemophi l us and gram-posit ive
bact eria, wit h predominance of St r ept ococci ; t he
isolat ion of anaerobes is uncommon. The Pseudomonas
species isolat ed are highly sensit ive t o polymyxin B,
ciproloxacin and gentamicin, while St aphyl ococci
species are sensit ive t o cloxacillin, gent amicin and
ciproloxacin.40, 98 The isolat es in t he periods of ot orrhea
are mostly polymicrobial. The microbiological proile
of ot it is media wit h cholest eat oma is similar t o t hat
of simple chronic ot it is media, wit h t he except ion t hat
anaerobes are more f requent , mainly Bact er oi des and
Pept ococcus; anaerobes have been isolat ed in up t o t wo
t hirds of ot orrhea wit h cholest eat oma. 40,97 Alt hough it is
assumed t hat ot it is media wit h ef f usion does not present
act ive inf ect ion, microorganisms are isolat ed in up t o
50% of cases, most f requent ly Haemophilus inluenza, M.
cat ar r hal i s and St r ept ococcus pneumoni ae. 40
Clean otologic surgery
Because t he incidence of infect ion is so low in clean
ot ologic surgery, t he risk of bet a error is very high; a very
large sample size would t herefore be required t o show
statistically signiicant differences. Most studies do not
different iat e bet ween clean, clean-cont aminat ed and dirt y
surgery.
Donaldson et al., 99 in a double-blind RCT on 96 pat ient s
undergoing myringoplasty, showed no statistically signiicant
62
differences bet ween using oral sulfamet hoxazole or
placebo. However, t his st udy did not specify t he lengt h of
t reat ment and t he packing was impregnat ed wit h polymyxin
B and neomycin. John et al. 100 conduct ed a single blind
RCT on 130 pat ient s undergoing myringoplast y, wit h one
group of pat ient s receiving syst emic ant ibiot ics (ampicillin
and lucloxacillin). No signiicant differences were found
in t erms of graft success; in fact , graft failure was more
frequent in t he group t reat ed wit h ant ibiot ics. In t hat
st udy, pat ient s did not receive ant ibiot ics on t he packing
t hey carried for 1 week.
The incidence of perichondrit is in pat ient s undergoing
ear pavilion surgery is est imat ed at bet ween 0%and 5.56%.
In an RCT101 on 84 pat ient s undergoing ear pavilion surgery
with closure for second intention, no signiicant beneit in
the use of systemic levoloxacin was shown.
In view of t hese clinical t rials wit h evidence level A,
t here is no evidence t o recommend t he perioperat ive
use of syst emic ant ibiot ics in pat ient s undergoing clean
ot ologic surgery wit h packing. It must be kept in mind
that there are no clinical trials that evaluate the eficacy
of t opical ant ibiot ic versus placebo; t he st udy populat ion
in t hese clinical t rials is composed of pat ient s undergoing
myringoplast y. Some aut hors have recommended t he use
of syst emic ant ibiot ics t o reduce t he risk of labyrint hit is;
however, t his has not been corroborat ed by clinical
t rials.
Clean-contaminated and dirty otologic surgery
There are few RCTs in which t he st udy populat ion is composed
exclusively of pat ient s undergoing “ unclean” surgery.
In t he RCT of Tong et al. 102 on 101 pat ient s wit h chronic
ot it is media undergoing t ype I t ympanoplast y, preoperat ive
topical oloxacin was administered for 2 weeks. Although a
signiicant negativisation was shown in the cultures, there
were no statistically signiicant differences in postoperative
infect ion. It can be concluded t hat a colonized ear does
not necessarily imply infect ion. There are no ot her clinical
t rials comparing t reat ment wit h t opical ant ibiot ics versus
placebo in surgery for chronic otitis. Thus, the beneit of
preoperat ive t opical t reat ment has not been demonst rat ed
(level of evidence B). However, t his st udy should be assessed
wit h caut ion, since t here are no clinical t rials t hat evaluat e
t he usefulness of post operat ive t opical ant ibiot ics in clean-
cont aminat ed and dirt y surgery.
Several st udies have evaluat ed t he use of syst emic
ant ibiot ics versus not using ant ibiot ics. In an RCT103 on 26
pat ient s wit h chronic ot it is media and posit ive cult ures for
P. aeruginosa, t he perioperat ive use of syst emic ceft azidime
has been shown to be statistically signiicant in reducing
post operat ive ot orrhea. Anot her RCT97 on 72 patients
diagnosed wit h chronic suppurat ive ot it is undergoing closed
t ympanomast oidect omy, of which 40 had cholest eat oma,
evaluated the eficacy of perioperative clindamycin
and gentamicin. There were no statistically signiicant
differences wit h regard t o infect ion bet ween t he group
t reat ed wit h ant ibiot ics and t he unt reat ed one (11 vs 14%).
Bagger-Sj oback et al., 104 in anot her double-blind RCT on 100
pat ient s undergoing middle ear surgery, including chronic
otitis media, showed no statistically signiicant beneit
in t erms of infect ion in pat ient s t reat ed wit h placebo or
S. Obeso et al
phenoxypenicillin; nevertheless, a signiicant reduction
in t he growt h of pat hogens was proven (P<.04). Based on
these studies, the beneit of using systemic antibiotics
versus placebo or not t reat ing has not been clearly shown
in clean-cont aminat ed ot ologic surgery. Nevert heless, t here
are subgroups, such as pat ient s in t he ot orrhea phase, for
whom it is useful. Furt her prospect ive st udies would be
necessary, as well as randomised st udies wit h a populat ion
t hat includes only clean-cont aminat ed surgery and dirt y
surgery.
Several clinical t rials have evaluat ed t he use of syst emic
and t opical ant ibiot ics versus t opical ant ibiot ics. These
st udies lack rigor when it comes t o segregat ing pat ient s
wit h chronic suppurat ion f rom t hose wit h clean ears. In
t he RCT of Govaert s et al. 105 on 750 patients undergoing
middle ear surgery and using a packing impregnat ed
wit h polymyxin B and neomycin, including pat ient s wit h
chronic otitis, no signiicant difference was found in
t erms of inf ect ion by adding perioperat ive cef uroxime
f or less t han 24h; t he higher incidence of early inf ect ion
in pat ient s wit h cholest eat oma who were not t reat ed
with cefuroxime was signiicant in that study, although
lat er on t he incidences were mat ched. Jackson et al. , 93
in a double-blind RCT on 3, 481 pat ient s undergoing
clean, clean-cont aminat ed and dirt y middle ear surgery,
in addit ion t o neuro-ot ologic procedures, showed no
signiicant beneit in using oral antibiotics for 24 h
prior t o a packing impregnat ed in polysporin used by
bot h groups. Separat ely analysing clean and dirt y ears
resulted in no signiicant relationships either between
adding t opical ant ibiot ic t o t he oral ant ibiot ic and a
lower incidence of infection. A signiicant relationship
was found between infection and dirty ears (17.2% in
dirt y ears and 4. 4% in clean ears; P<. 05). Hest er et al. , 106
in an RCT on 146 pat ient s undergoing middle ear surgery
f or chronic suppurat ive ot it is, assessed t he usef ulness of
syst emat ically administ ering ampicillin-sulbact am during
t he int ervent ion and amoxicillin-clavulanat e f or 5 days;
all pat ient s carried gel f oam and colist in in t he middle
ear and a packing wit h bacit racin, in addit ion t o t aking
neomycin and polymyxin B af t er removal of t he packing.
No signiicant differences were found in infection or
graf t f ailure bet ween t he groups. Considering t he above,
st udies wit h evidence level A have f ailed t o demonst rat e
the beneit of adding systemic antibiotics to topical
ant ibiot ics in clean-cont aminat ed and dirt y surgery.
A recent met a-analysis94 published in 2007 evaluated
several randomised and prospect ive t rials on ant ibiot ic
prophylaxis in clean and clean-cont aminat ed ot ologic
surgery. The subgroups could not be analysed. No signiicant
difference was found bet ween using ant ibiot ic or not , using
syst emic ant ibiot ic or not , using t opical ant ibiot ic or not , or
using syst emic and t opical ant ibiot ic compared wit h t opical
ant ibiot ic alone.
Prophylaxis in transtympanic drains
Post operat ive ot orrhea in pat ient s wit h t ranst ympanic
drains (TTD) ranges between 3.4 and 74%, although the
real igure is closer to 15-19%.107 In a met a-analysis108
f rom 2006, t he relat ive risk in t erms of occurrence of
post operat ive ot orrhea in t he pat ient group wit h TTD
Ant ibiot ic prophylaxis in ot olaryngologic surgery
t reat ed f or more t han 48 hours wit h a t opical ant ibiot ic
compared wit h unt reat ed pat ient s was 0.52% (0.39%-
0.69%); t opical ant ibiot ic t reat ment reduces t he incidence
of postoperative otorrhea by up to 48%. The beneit of
t opical ant ibiot ics in reducing post operat ive ot orrhea is
demonstrated with a level of evidence A. No signiicant
differences were found between oloxacin and neomycin
wit h polymyxin B.
Several well-designed RCTs have shown no signiicant
differences in t he incidence of ot orrhea in pat ient s t reat ed
wit h normal int raoperat ive serum washings, post operat ive
oral ant ibiot ic, post operat ive t opical ant ibiot ic or
perioperat ive washings wit h oxymet azoline. 109,110 As t he
greater eficacy of intraoperative irrigation with saline
solution is conirmed in another randomised clinical
t rial, 111,112 t here is a level of evidence A t o recommend
washing wit h saline solut ion; it is a cheaper t reat ment and
also has a better safety proile. We thus conclude that it
should be t he rout ine t reat ment in pat ient s undergoing TTD
placement .
Antibiotic prophylaxis in cochlear implants
Surgical wound inf ect ion in surgery f or cochlear implant at ion
is a rare phenomenon, est imat ed at around 4%(depending
on t he series, bet ween 0.9% and 11.8%). 113,114 Cochlear
implant surgery is f ramed wit hin clean surgery, and t he
low incidence of local inf ect ion implies t hat perioperat ive
antibiotics will not be recommended in the irst years of
t he t echnique. However, t here are no randomised st udies
comparing t he incidence of local inf ect ion in pat ient s wit h
and wit hout ant ibiot ic t reat ment . In a survey conduct ed
in 1989, 56.4% of 1,030 implant ed pat ient s had received
perioperat ive ant ibiot ics; in 4.5% of pat ient s wit hout
ant ibiot ic t reat ment it was necessary t o remove t he
implant , while t his decision was t aken in only 0.9% of
pat ient s wit h prophylaxis. 115
However, t he FDA report ed in 2002116 an increase of
bact erial meningit is in implant ed pat ient s; unt il 2003,
t here were 118 cases of bact erial meningit is, predominant ly
st rept ococcal, in pat ient s aged bet ween 13 mont hs and 81
years. The lat ency period bet ween t he int ervent ion and
t he onset of sympt oms ranged from less t han 24h t o over 6
years. Of these cases, a cerebrospinal luid (CSF) culture was
carried out in 69, which was posit ive for S. pneumoniae in
46. In t his 2003 alert as in a new one in 2006, evaluat ing t he
use of perioperat ive ant ibiot ics t o prevent t his complicat ion
was recommended; however, t he recommendat ion is
ambiguous and does not specify t he t ype of ant ibiot ic, it s
dose or t he durat ion of t he t reat ment . 116,117
It has been suggest ed t hat cochlear implant placement
lowers t he t hreshold t o cause meningit is, a circumst ance
that seems to be inluenced by the use of placeholders (now
obsolet e), t he t raumat ic placement of t he implant and t he
reduct ion in t he int racochlear defensive capacit y produced
by a foreign body, all based on st udies in animal models. 118
In animal implant at ion models, it has been shown t hat
t he concent rat ion of S. pneumoniae inoculum t hat causes
meningit is is less if t he inner ear is inoculat ed t han if it
is administ ered syst emically; t he concent rat ion required is
great er when t he middle ear is inoculat ed. 119
63
Hirsch et al., 114 in a ret rospect ive st udy on 95 implant ed
pat ient s, declared no maj or infect ion and 1% of minor
infect ions; 83% of pat ient s received at least 4 doses of
perioperat ive cefazolin. Basavaraj et al. 113 ret rospect ively
analysed 292 implant ed pat ient s and regist ered 4 maj or
infect ions (3 of which occurred in pat ient s t reat ed wit h long
ant ibiot ic regimes), 8 minor infect ions and no meningit is; t he
use of long antibiotic regimes was signiicantly associated
wit h post operat ive infect ion (5.6% in t reat ment for 5 days
and 13% in treatment for 7 days) versus administration of
single doses. However, t his was a ret rospect ive st udy and
t he assignment was not randomised, so pat ient s wit h long
regimes may have been t hose who showed signs of infect ion
early.
The haemat o-labyrint hine barrier may be a hindrance for
t he penet rat ion of ant ibiot ics. There are no st udies on t he
use of t opical ant ibiot ics in humans, but t here are some
in experiment al models. Wei et al. 120 showed t hat coat ing
the implant with ciproloxacin had a signiicant protective
effect in t erms of onset of meningit is when S. pneumoniae
was inoculated in blood; however, this was not signiicant
for inoculat ion in t he inner or middle ear.
For all t hese reasons, t here is a level of evidence C t o
recommend t he use of perioperat ive syst emic ant ibiot ics
in cochlear implant at ion; t here are no clinical t rials and
hardly any ret rospect ive st udies t hat evaluat e t he use of
ant ibiot ic versus placebo or different ant ibiot ic regimes.
The most widely used ant ibiot ic is cefazolin, which provides
good coverage against gram-posit ive cocci, wit h highly
variable regimes depending on t he inst it ut ion.
Antibiotic prophylaxis in dural exposure
In clean neurosurgical procedures, t here is no penet rat ion
int o t he respirat ory and gast roint est inal t ract s and asept ic
t echnique is not violat ed. This group includes craniect omies,
including neuro-ot ologic approaches. The incidence of local
infect ion is around 2%-3%121 and t he most import ant risk
factor is CSF istula.122
There are several double-blind RCTs122,123 t hat evaluat e
t he administ rat ion of ant ibiot ic prophylaxis versus placebo
in clean craniect omies, and t he reduct ion of surgical
infection in patients receiving antibiotics is signiicant.
A met a-analysis by Barker et al. 125 assessed t he presence
of surgical wound infect ion in pat ient s undergoing clean
craniect omies, such as t ranst emporal approaches, and a
local infection incidence of 8.7% was calculated for the
group not receiving ant ibiot ic versus 1.8% for t he t reat ed
group (signiicant differences). Therefore, there is evidence
of level A t o recommend t he prophylact ic use of syst emic
ant ibiot ics in clean craniect omies.
In 2007, Barker126 published a new met a-analysis
t hat evaluat ed t he incidence of meningit is in clean
craniect omies regardless of t he applicat ion or not of
ant ibiot ic prophylaxis. Of t he six RCTs included, none
detected statistical signiicance; combining the individual
dat a, t he incidence of meningit is in t he groups wit h and
without antibiotics was 1.1% and 2.7%, respectively (not
a signiicant difference); on the other hand, the number
of pat ient s who required t reat ment t o prevent a case of
meningit is was 65.
64 S. Obeso et al

Table 5 Main conclusions on ant ibiot ic prophylaxis in head and neck surgery, based on current ly- available evidence

Laryngopharyngeal clean-cont aminat ed surgery

Amoxicillin-clavulanat e does not decrease t he incidence of infect ion versus cefazolin Level A
The combinat ion of clindamycin and gent amicin does not reduce t he incidence of infect ion compared Level B
wit h clindamycin
The combinat ion of clindamycin and gent amicin does not reduce t he incidence of infect ion versus cefazolin Level B
or amoxicillin-clavulanat e
There is no evidence t hat regimes prolonged furt her t han 24h decrease t he incidence of infect ion Level A
compared t o perioperat ive regimes
Topical washings with antibiotics signiicantly reduce colony forming units in saliva compared to systemic Level A
ant ibiot ics
Washings wit h t opical ant ibiot ics reduce t he incidence of infect ion compared t o placebo Level B
The combinat ion of t opical and syst emic ant ibiot ics reduces t he incidence of infect ion compared Level B
t o syst emic ant ibiot ics alone

Flap reconst ruct ion in clean-cont aminat ed surgery

Clindamycin does not decrease t he incidence of infect ion wit h respect t o cefazolin Level B
Prolonged 5-day prophylact ic regimes do not reduce t he incidence of infect ion wit h respect t o 1-day regimes Level A

Laryngopharyngeal laser surgery

There are no clinical t rials or expert consensus in t his respect

Rhinologic surgery
Perioperat ive syst emic ant ibiot ics do not decrease morbidit y or infect ion in sept oplast y Level A
Topical ant ibiot ics reduce t he colonizat ion of t he packings in sept oplast y Level A

Tonsillect omy
Perioperat ive syst emic ant ibiot ics reduce fever and halit osis and enable an early ret urn t o t he usual diet Level A
and act ivit y
Perioperat ive syst emic ant ibiot ics do not reduce pain or t he risk of bleeding Level A
Systemic antibiotics do not provide beneits with respect to topical antibiotics Level A
Topical ant ibiot ics reduce pain wit h respect t o syst emic ant ibiot ics Level B

Ot ologic surgery
Syst emic ant ibiot ics do not reduce t he incidence of infect ion in clean surgery Level A
Syst emic ant ibiot ics do not reduce t he incidence of infect ion in clean-cont aminat ed surgery Level B
Systemic antibiotics provide no beneit with respect to topical antibiotic treatment in clean-contaminated Level B
surgery
Perioperat ive syst emic ant ibiot ics reduce infect ion in clean-cont aminat ed surgery and wit h Level B
posit ive preoperat ive cult ures
Wit hout st rat ifying t he different cat egories of ot ologic surgery, perioperat ive ant ibiot ics do not reduce Level A
incidence of infect ion
Post operat ive t opical ant ibiot ics reduce t he incidence of ot orrhea aft er t he placement of t ranst ympanic drains, Level A
although they do not provide beneits with respect to intraoperative washing with serum

Cochlear implant
Perioperat ive syst emic ant ibiot ics reduce t he incidence of meningit is Level C

Neurological approaches
Prophylact ic syst emic ant ibiot ics reduce t he incidence of infect ion and meningit is in clean craniect omies Level A
Perioperat ive syst emic ant ibiot ics reduce t he incidence of infect ion in clean-cont aminat ed approaches: Level C
skull base surgery and endoscopic approaches

There are no RCTs t hat assess t he durat ion of ant ibiot ic
prophylaxis. Most st udies used regimes of 24h or less123,124,127,128
and Barker’s met a-analysis125 demonst rat ed no difference
bet ween t he use of a single dose or of mult iple doses. There
are no RCTs demonstrating the beneit of one antibiotic
regime over anot her; it is necessary t o cover gram-posit ives
and the beneit in extending coverage to gram-negatives
has not been shown. 121,125 Given the safety proile, lower
cost , reduced spect rum, low presence of gram-negat ive in
infect ion and t he absence of RCTs t hat refut e t heir suit abilit y,
Ant ibiot ic prophylaxis in ot olaryngologic surgery
we recommend cefazolin as prophylaxis, according t o t he
ASHP. 3 Following administ rat ion of 1 g of cefazolin, t he
serum peak is reached aft er one hour. Concent rat ions above
t he MIC of most common germs in post operat ive infect ions
are maint ained for 12h in t he wound and serum, wit h t he
except ion of E. coli and A. f aecalis; however, t his is only
maintained for 5h in cerebrospinal luid.129 Therefore, doses
should be repeat ed at 4-hour int ervals.
In clean-cont aminat ed neurosurgical procedures, t here
is a communicat ion bet ween t he int racranial cavit y and
t he respirat ory or gast roint est inal t ract . The ant erior or
lat eral approaches of skull base surgery, t ranssphenoidal
surgery and endoscopic surgery of t he skull base belong t o
t his cat egory. 130 The incidence of infect ious complicat ions
in craniofacial resect ions ranges bet ween 18% and 38%. 131
Ant ibiot ic prophylaxis is recommended for t he durat ion
of exposure in t hese cases. There are no RCTs t hat assess
t he need for ant ibiot ic prophylaxis in clean-cont aminat ed
surgery, different regimes or t opical ant ibiot ic t reat ment .
There is no evidence t o suggest one regime over anot her.
Ant ibiot ic t reat ment wit h t herapeut ic int ent is
recommended in cont aminat ed or dirt y procedures.
Conclusions
Table 5 summarises some of t he conclusions t hat can be
drawn from t his review in t he form of st at ement s and t heir
corresponding level of evidence.
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