1
2
Draft Therapeutic Guidelines on Antimicrobial Prophylaxis in Surgery
Section: Neurosurgery
3
4
Background. Nosocomial central nervous system infections are low in incidence but have
5
potentially serious consequences and poor outcomes, including death.258 One of the greatest risks
6
for these infections in children and adults is undergoing a neurosurgical procedure. A
7
classification system for neurosurgery, validated by Narotam and colleagues, divides procedures
8
into five categories: clean, clean with foreign body, clean-contaminated, contaminated, and
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dirty.258a Clean procedures in neurosurgery include elective craniotomy, spinal procedures, and
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laminectomy and those with foreign body procedures are those with either a temporary or
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permanent foreign body left in situ (e.g. shunt, intracranial pressure monitors, clamps, ventricular
12
drains, acrylic cranioplasties and metal rods). Laminectomy and spinal procedures are performed
13
by both orthopedic and neurosurgeons and are addressed in the Spinal Procedures With and
14
Without Instrumentation section of these guidelines.
15
The reported incidence of postoperative infection, including meningitis, in clean
16
procedures (primarily craniotomy) ranges from 0.15% to 6.1% with antimicrobial
17
prophylaxis258,258a-258c,258d,258f-258l and 2% to 9.7% with placebo or no antimicrobial
18
prophylaxis.258,258c,258f-258h Postoperative central nervous system (CNS) shunt infections are
19
associated with serious morbidity and mortality with incidence reported up to 20%.258a,258k,260–
20
262262a-262j
21
(CSF) infection, and less frequently, surgical site infection.259 The majority of neurosurgical site
22
infections and other postoperative infections typically occur within two weeks to one
23
month.258h,258j,262h,262i
Postoperative CNS infections include meningitis, ventriculitis, cerebrospinal fluid
24
Clean-contaminated procedures are those with a risk of contamination during the
25
procedures with entry into paranasal air sinuses and transsphenoidal or transoral procedures.258a
26
Contaminated procedures have known preoperative contamination (e.g. compound skull
27
fractures, open scalp lacerations, cerebrospinal fluid (CSF) fistulae) or established sepsis at the
28
time of procedure.258a Patients undergoing contaminated and dirty procedures are given
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antibiotics as treatment; therefore, these procedures are not reviewed in these guidelines.
30
Risk factors for postoperative infections following neurological procedures include
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American Society of Anaesthesiologists (ASA) score > 2,258i postoperative duration (> 5 days)
32
of intracranial pressure monitoring258i,262f or ventricular drains,258,258i CSF leak,258h,258l,262f
1
33
procedure duration more than two to four hours,258f,258g,258h,258j diabetes,258j placement of foreign
34
body,258 repeat or additional neurosurgical procedures,258f,258g,258i,258l concurrent (remote,
35
incision, or shunt) or previous shunt infection,258,262d,262f,262k and emergency procedures.258f,262d
36
37
Organisms. Data from most published clinical trials indicate that surgical site infections are
38
primarily associated with gram-positive bacteria, S. aureus and coagulase-negative
39
staphylococci.258a, 258b,258d-258j,258l,262a-262d, 262f, 262h-262j,262l,262m Several cohort studies reported concern
40
of high rates (up to 75 or 80% of isolates) of methicillin-resistant Staphylococcus aureus258d,258f-
41
258h,258l,262a-262c,262h
42
neurosurgical procedures at their institutions.258g,258h,262a,262f Gram-negative bacteria have also been
43
isolated as the sole cause of postoperative neurosurgical surgical site infections, in approximately
44
5% to 8% of cases and have been isolated in polymicrobial
45
infections.258a,258b,258d,258f,258g,258i,258j,258l,262a,262b,262d,262f,262h,262i
and coagulase-negative staphylococci among patients undergoing a variety of
46
47
Efficacy for Clean Neurosurgical Procedures. Antimicrobial prophylaxis is recommended for
48
adult and pediatric patients undergoing craniotomy and spinal procedures.262o,262p One meta-
49
analysis of six studies found decreased odds of meningitis in patients undergoing craniotomy
50
who received antimicrobial prophylaxis (1.1%) compared with no prophylaxis (2.7%) (p =
51
0.03).258c
52
Two cohort studies258g,258h in patients undergoing craniotomy at the same institution
53
found that antibiotic prophylaxis with cloxacillin or amoxicillin/clavulanate, clindamycin for
54
penicillin allergic patients, and other antibiotics (not listed) had a significantly lower infection
55
rate (5.8%) than no prophylaxis (9.7%) (p < 0.0001).258g A significantly lower infection rate of
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4.6% was seen in low-risk patients (clean craniotomy, no implant) with antimicrobial
57
prophylaxis versus those without (4.6% vs 10%, p < 0.0001). A significantly lower incidence of
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scalp infections, bone flap osteitis and abscess or empyema was seen with antimicrobial
59
prophylaxis compared with no prophylaxis. Antimicrobial prophylaxis demonstrated no
60
difference in postoperative meningitis258g,258h and infection rate in high-risk patients (emergency,
61
clean-contaminated and dirty procedures, operative time longer than 4 hours, and re-
62
63
operation).258g
64
neurosurgical postoperative infection rates when antimicrobial prophylaxis is used.263–266 One such
2
Prospective studies involving large numbers of patients have also demonstrated lower
65
study in craniotomy, spinal, and shunting procedures was stopped early because of an excessive
66
number of surgical site infections in the placebo group.267
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Choice. Studies of clean neurosurgical procedures reported antibiotic regimens including
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clindamycin,258c,258g,258h vancomycin,258c,258f cefotiam (not marketed in the US),258c
69
piperacillin,258c cloxacillin,258c,258g,258h oxacillin,258c,258f cefuroxime,258b cefotaxime,258d
70
sulfamethoxazole/trimethoprim, cefazolin,258f,258j penicillin g,258f and amoxicillin/clavulanate.258f-
71
258h
72
regimens of clindamycin, vancomycin or cefotiam; three doses of piperacillin; four doses of
73
cloxacillin; and six doses of oxacillin) in incidence of post-craniotomy meningitis in a meta-
74
analysis.258c
75
No significant difference was noted between various antimicrobial regimens (single-dose
A randomized, open-label, multicenter study of 613 adult patients undergoing elective
76
craniotomy, shunt or stereotactic procedures found no difference in single-doses of cefotaxime
77
and trimethoprim/sulfamethoxazole in postoperative abscess formation and surgical site and
78
shunt infections.258d
79
The routine use of vancomycin as antimicrobial prophylaxis is not recommended, but
80
may be reserved for patients with a beta-lactam allergy, with a previous history of MRSA
81
infection, at institutions with a high rate of methicillin-resistant Staphylococcus aureus (MRSA)
82
or methicillin-resistant Staphylococcus epidermidis (MRSE) surgical site infections or patients
83
colonized or infected with MRSA. 21,262l-262o
84
85
Duration. The majority of studies included single-doses of antibiotics; therefore the use
86
of single-dose antibiotic prophylaxis given within 60 minutes prior to incision in patients
87
undergoing neurosurgery is generally recommended.258b-258d,258g,258h,262m,262o-262q
88
Additional intraoperative doses of antimicrobial agents are recommended if the procedure is
89
more than three or four hours in duration or if the duration of the procedure exceeds two half-
90
lives of the antibiotics administered preoperatively, or if major blood loss occurs.
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procedure
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93
Pediatric Efficacy for Clean Neurosurgical Procedures. There are no studies in pediatric
94
patients looking at efficacy of antimicrobial prophylaxis in clean neurosurgical procedures;
95
efficacy is extrapolated from adult studies.262o
96
3
97
98
99
Efficacy for Cerebrospinal Fluid-Shunting Procedures.
Antimicrobial prophylaxis is recommended for adults undergoing placement of a
cerebrospinal fluid shunt.262o Prophylaxis in patients undergoing ventriculostomy or
100
intraventrical prophylaxis at the time of ventriculoperitoneal shunt insertion has shown some
101
102
benefit in reducing infection, but remains controversial due to limited evidence.262m,262o
103
and morbidity, especially in children, the possible role of prophylactic antimicrobials in such
104
procedures has been studied in numerous small, well-conducted, randomized, controlled trials.268–275
105
Meticulous surgical and aseptic technique and short procedure time were determined to be important
106
factors in lowering infection rates after shunt placement. Although the number of patients studied in
107
each trial was small, two meta-analyses of these data demonstrated that antimicrobial prophylaxis use
108
in CSF-shunting procedures reduces the risk of infection by approximately 50%.276,277
109
Because CNS infections after shunting procedures are responsible for substantial mortality
There is no consensus on the use of antimicrobial prophylaxis in patients with
110
extraventricular drains (EVD) or intracranial pressure (ICP) monitors.277a An international survey
111
of neurosurgeons, critical care medicine and infectious disease specialists illustrates the
112
difference in practices. The majority of the neurosurgeons used or recommended use of
113
antimicrobial prophylaxis with EVDs (73.5%) and other monitoring devices (59%) compared
114
with response rates of 46-59% and 35% of other specialty respondents, respectively. The
115
majority of specialties did not recommend or use antimicrobial-coated EVD catheters.
116
Routine use of antibiotic-impregnated devices is not recommended; additional well-
117
designed studies are needed to establish their place in therapy.262o,277b Two randomized
118
controlled studies comparing antibiotic-impregnated shunts to standard, non-antibiotic-
119
impregnated shunts along with antimicrobial prophylaxis, intravenous cephalosporin, found a
120
121
decrease in rates of shunt infections262a and a significant decrease in CSF infection.262d
122
have greater efficacy over others 258d,262c,262g-262k There is a lack of data on CNS penetration of
123
antimicrobials as it relates to prevention of infection in CNS shunting procedures.
Choice. In CSF-shunting procedures, no single antimicrobial has been demonstrated to
124
Duration. The majority of studies support use of single-dose prophylaxis regimens or
125
regimens with a duration of 24 to 48 hours postoperatively.258e,262a-262c,262f-262h,262k-262m,262o,262p
126
There is a lack of data evaluating the continuation of extraventricular drains with and
127
without antimicrobial prophylaxis. The international survey mentioned above asked respondents
128
to indicate their recommended duration for antimicrobial prophylaxis with EVD as either
4
129
periprocedural, for 24 hours, first three days, entire time device is in place or other.277a The
130
respondents from the specialties of neurosurgery, neurocritical care and critical care had similar
131
results of 28-31% using or recommending periprocedural antibiotics, 4-10% for 24 hours, 2-4%
132
for first three days, 43-64% for the entire time device is in place and 0-14% other. The infectious
133
diseases specialists reported rates of 62%, 19%, 4%, 12% and 4%, respectively.
134
One retrospective single-center cohort of 308 patients with EVDs placed for three or
135
more days received antimicrobial prophylaxis for the duration of EVD use (n = 209) compared
136
with patients receiving cefuroxime 1.5 grams intravenously every 8 hours for three doses or less
137
periprocedurally (timing not clearly defined in paper) (n = 99).262r The overall infection rate of
138
bacterial ventriculitis was 3.9% with eight (3.8%) in the extended use group and four (4%) in the
139
short-term prophylaxis group, which was not statistically significant. Authors concluded that
140
141
there was no benefit to use of continuous antimicrobial prophylaxis.
142
143
Pediatric Efficacy for CSF-Shunting Procedures.
144
cerebrospinal fluid shunt.262o There are no studies evaluating efficacy in pediatric CSF-shunting
145
procedures. The efficacy of antimicrobial prophylaxis is extrapolated from adult studies.
Similarly, antimicrobial prophylaxis is recommended for children undergoing
146
A retrospective pediatric study of 1201 CSF-shunting procedures failed to demonstrate a
147
significant difference in infection rates between patients who received antimicrobials (2.1%) and
148
those who did not (5.6%). Two randomized, prospective studies that included pediatric patients
149
did not demonstrate a significant difference in infection rates between the control group and the
150
groups that received cefotiam275 (not available in the US) or methicillin.272 A randomized,
151
double-blind, placebo-controlled study that included pediatric patients undergoing
152
ventriculoperitoneal shunt surgeries failed to demonstrate that the use of perioperative
153
sulfamethoxazole–trimethoprim reduced the frequency of shunt infection.268
154
Other studies have demonstrated efficacy for prophylactic antimicrobials.270,278 A single-
155
center, randomized, double blind, placebo-controlled trial of perioperative rifampin plus
156
trimethoprim was performed in pediatric patients.278 Among patients receiving rifampin plus
157
trimethoprim, the infection rate was 12%, compared with 19% in patients receiving placebo. The
158
study was ended (because of the high infection rates) before significance could be achieved.
159
Infection rates at the study institution had been 7.5% in the years before the study. An open-label
160
randomized study, including pediatric patients, demonstrated a lower infection rate in a group
5
161
162
receiving oxacillin (3.3%) than in a control group (20%).270
A survey of North American pediatric neurosurgical practitioners found that all 100
163
respondents were familiar with antibiotic-impregnated shunt catheters, but only 61% used them
164
in practice.270a Routine use was reported by only eleven respondents, while the remaining used
165
them more than half the time (n = 20) and less than 50% of the time (n = 30). Reasons for use
166
included revisions for shunt infection (n = 27), prophylaxis (n = 24), immunocompromised
167
patients (n = 17), neonates or premature infants (n = 14) and pediatric patients only (n = 3).
168
Fifty-nine of the respondents were familiar with antimicrobial sutures. Among the 14
169
respondents who had used them in practice, the majority reported use in 80% of shunt cases (n =
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13) and one stated 10% of cases. All of the respondents used antimicrobial prophylaxis
171
intravenously and intraventricularly (27%) during shunt surgery.
172
Based on the available evidence, the routine use of antibiotic-impregnated devices is not
173
recommended in this population.262o,277b One cohort of 78 pediatric patients who underwent CSF
174
diversion procedures compared antibiotic-impregnated shunts to standard, non-antibiotic-
175
impregnated shunts along with intravenous cefazolin on the day of the procedure and one day
176
postoperatively. The decrease in the rates of shunt infections was not statistically different
177
between the two groups.
178
A small, randomized, placebo-controlled, single-center study of 61 patients stratified by
179
weight, age and shunt infection evaluated the incidence of early (< 6 months postoperatively)
180
shunt infection with triclosan-coated absorbable sutures after CSF shunt procedures.277c All
181
patients received intravenous cefazolin (or vancomycin for cephalosporin-allergic patients),
182
antibiotic wound irrigation prior to site closure, and had the silicone shunt soaked in bacitracin
183
solution prior to implantation. The median age of patients was 6.3 years with a range from 1 day
184
to 48 years. After a second interim analysis, shunt infections were diagnosed in two of the 46
185
patients (4.3%) in the antimicrobial-coated suture group and eight of the 38 patients (21%) in the
186
placebo suture group (p = 0.038). The study was stopped after this analysis. The authors
187
concluded that the number needed to treat with the sutures was six. Larger, longer-term studies
188
are needed to establish the efficacy, safety and costs associated with use of antimicrobial-coated
189
190
sutures.
191
Recommendation. A single-dose of cefazolin 1 gram intravenously administered within 60
192
minutes prior to skin incision is recommended for patients undergoing clean neurosurgical
6
193
procedures or CSF-shunting procedures. Vancomycin 1 gram intravenously within two hours
194
prior to skin incision. should be reserved as an alternative agent for patients with beta-lactam
195
allergy, patients in an institution with a high prevalence of MRSA or MRSE surgical site
196
infections and patients colonized or at high-risk for colonization with MRSA. Additional
197
intraoperative doses of antimicrobial agents are recommended if the procedure is more than three
198
or four hours in duration or if the duration of the procedure exceeds two half-lives of the
199
antibiotics administered preoperatively, or if major blood loss occurs.
200
Additional discussion of weight-based antimicrobial dosing is included in the common principles
201
section of these guidelines. (Strength of evidence for prophylaxis for clean neurosurgical
202
procedures = A.) (Strength of evidence for prophylaxis for CSF-shunting procedures = A.)
203
204
Pediatric. The recommended regimen for pediatric patients undergoing clean neurosurgical
205
procedures or CSF-shunting procedures is a single dose of intravenous cefazolin 20–30 mg/kg
206
administered within 60 minutes prior to skin incision. Vancomycin 15 mg/kg intravenously
207
should be reserved as an alternative agent for patients with beta-lactam allergy, patients in an
208
institution with a high prevalence of MRSA or MRSE surgical site infections and patients
209
colonized or at high-risk for colonization with MRSA. Additional intraoperative doses of
210
antimicrobial agents are recommended if the procedure is more than three or four hours in
211
duration or if the duration of the procedure exceeds two half-lives of the antibiotics administered
212
preoperatively, or if major blood loss occurs.
7
213
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