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according to the level and type of contamination at were considered separately from clean cases, whereas
the time of surgery. Infection included all abnormal cranioplastic procedures were included (4,12,14,15,28,30).
wounds and was documented as deep when infection We propose that to categorize a neurosurgical case as
occurred beneath the galea (subgaleal pus, osteitis, "clean," there must be absolutely no factor present
abscess/empyema, ventriculomeningitis) and as known to increase the risk of infection, including the
superficial if only the scalp (including wound presence of a foreign body.
erythema) was involved. A statistically significant Unfortunately, the diagnosis of sepsis in various
difference in the sepsis rate was found in the different series has not been uniform, which has complicated
categories (P < 0.0001). Of the 342 "dirty cases," comparative analysis (2,6,14,15,17,19,20,22,28,29,31). Wright
(30)
9.1% of patients developed further wound sepsis. defined neurosurgical wound sepsis as "purulence,
Concomitant cerebrospinal fluid fistulae (44%), meningitis or osteitis," established beyond doubt by
second operations (11.8%), and patients with the presence of pathogenic bacteria. Malis (17)
penetrating injuries (9.2%) were the major factors classified the wounds in his report as septic only if a
implicated in sepsis in the "contaminated" category positive culture was obtained from the discharging
(9.7%). In the "clean contaminated" category, a sepsis wound or if meningitis or meningism was present,
rate of 6.8% was found. Prolonged surgery (longer together with cerebrospinal fluid (CSF) leukocytosis
than 4 hours) was also implicated in higher infection and wound inflammation. These stringent criteria
rates (13.4%). This study strongly supports the have been adopted in various series reporting on
separation of patients who have foreign materials wound infection or on the use of prophylactic
implanted (sepsis rate = 6.0%) from "clean" patients, antibiotics (10-12,17). Wound swabs may not always
essentially cases categorized as having no known risk yield a pathogenic organism, especially when
factors that may affect sepsis, in whom a sepsis rate different or multiple bacterial isolates are found and
of 0.8% was found (P < 0.001). Importantly, surgery skin commensals may be falsely implicated. Clearly,
for the repair of so-called "clean" neural tube defects then, the incidence of wound infections can be
in neonates requires separate consideration. An underreported. The University of Maryland Hospital
infection rate of 14.8% existed in this subgroup. A later added the further criterion of "physician's
uniform system of reporting wound abnormalities is diagnosis," because any abnormal wound is of
also proposed. concern to the neurosurgeon (28).
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permanently or temporarily implanted foreign
materials present, namely, shunts, intracranial RESULTS
pressure monitors, reservoirs, and ventricular drains. During the 18-month period, 2249 surgical
Large, metallic foreign materials such as Halifax procedures were performed. Overall, 92 deep wound
clamps, Caspar plates, and Luque rectangles were infections (4.1%) and 51 superficial wound infections
also included. Methyl methacrylate ("acrylic"), (2.3%) were recorded (Table 2). As expected, a
because it was not entirely homogenous, was higher risk of infection was found with an increasing
included. Smaller metallic foreign materials such as degree of contamination. The proposed classification
aneurysm clips and ligaclips were excluded. Sutures was evaluated by use of the χ2 test, which revealed
(vicryl) and monofilamentous materials (stainless that there was a significant difference within the five
steel wire) used for standard neurosurgical categories (P < 0.0001). On pairwise comparison, this
procedures and routine wound closure were also difference was the most marked between the clean
excluded. and the other four groups (P < 0.005). The
contaminated group had higher infection rates than
Clean both the clean contaminated and the clean with
The entry of a case into the "clean" category was foreign body (χ2, P < 0.05) groups. The differences
by the exclusion of all the above factors. Surgery was between the clean with foreign body and clean
usually elective, under ideal operating conditions, contaminated groups were not significant.
with closed suction bellows drainage placed in the The data obtained from the different categories
subgaleal space for a period not exceeding 24 to 48 were also analyzed by use of the criteria proposed by
hours. Wright (30) and those proposed by Malis (17), which
Hair was routinely shaved preoperatively, and the have been used in several studies on antibiotic
scalp was examined for wounds or local sepsis. prophylaxis. These were compared with the criteria
Savlon, followed by Hibitane in alcohol, was used as that we used in the above analyses and that had been
the standard method of skin preparation for surgery. modified from the recommendations of Lowbury (16)
All surgery was performed in one of two (Table 3). Significantly lower overall sepsis rates of
neurosurgical operating rooms by standard 3.8 and 3.7%, respectively, were obtained with the
techniques. In addition, Cephamandole (15 mg/kg) criteria of Malis (17) and Wright (30), compared with a
was used perioperatively in all clean, clean 6.4% infection rate with our criteria.
contaminated, and clean with foreign body cases.
Penicillin and sulfadiazine were used as prophylactic Dirty cases
antibiotics in "open" trauma patients. Of the 342 patients classified as dirty, further
The patients were monitored for sepsis septic complications occurred in 31 (9.1%) (Table 2).
postoperatively, either until the time of discharge Ventriculomeningitis (15 cases) was the major cause
back to the primary referral hospital or after 4 weeks of deep infection. There were also two brain
had elapsed if they were still in the hospital or had abscesses, and one case each of osteitis and subgaleal
returned for follow-up visits. (All septic cases at infection. Moderate to severe superficial skin
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A 6.8% infection rate occurred in the clean (chest infections, urinary tract infection, etc.).
contaminated category (Table 2). Although there Concurrent infections occurred in 17.4% of patients
were no significant differences in the subgroups, without wound infections (Table 9). This difference
prolonged surgery (i.e., longer than 4 hours duration) was not significant (χ2, P = 0.27).
had a tendency toward a higher infection rate (13.4%)
(Table 5). DISCUSSION
We have formulated a method of prospectively
Clean with foreign body analyzing neurosurgical procedures according to
The risk of infection was doubled when a foreign factors previously reported and those that are likely
body was introduced to what would previously have to increase the risk of infection by the use of specific
been regarded as a clean case (Table 2). This was criteria (14,20,24,28,30,31). We believe that the 2249
highly significant (χ2, P < 0.05; Bonferroni patients in the period of review represent the work of
adjustment, P < 0.005). The sepsis rate for subdural a busy general unit, treating a wide spectrum of
intracranial pressure monitoring was low (2.5%). neurosurgical disorders including a high proportion
Ventricular catheters, either for temporary CSF of septic and trauma cases (15 and 45%,
diversions (even when used for up to 72 to 96 hours) respectively). Elective spinal and cranial surgery in
or for intracranial pressure monitoring, exhibited a patients of all ages constituted only 40% of the
slightly higher infection rate (5.9%) than subdural workload.
catheters, but this was not significant (P > 0.05) (2) The selective exclusive classification and reporting
(Table 6). of wound infections by Wright (30) and by Malis (17)
have gained some acceptance (10,12,15,17,19,22,30).
Clean cases Certainly, an infection rate of 0% is easily achievable
After the exclusion of all known factors that if stringent exclusive criteria are used (17).
influence sepsis, 25% of the operative cases fell into Furthermore, despite the refined methods of specimen
the clean category (Table 2). Although one should collection, microbiological testing may not always
expect a zero infection rate, it was, in fact, 2.6%! On reveal the causative organism, even though the
further analysis, almost all infections occurred in wound may be clinically infected. This may require
neonates who had surgery for the repair of a closed further surgery, prolong the hospital stay, and
myelomeningocele, lipomyelomeningocele, or therefore, add to the morbidity. To obviate this
encephalocele. In this subgroup, the infection rate problem, Vlahov et al. (28) suggested the use of
was 14.8% (Table 7). Clearly, this has to be identified "wound infection as diagnosed by the surgeon." To
as an additional risk factor. With the exclusion of remove this bias in the reporting of superficial wound
these neural tube defect repairs, there were only four infections, we adopted the system as proposed by
patients with wound abnormalities (sepsis rate = Lowbury (16), whereby all abnormal wounds were
0.8%). Wound erythema occurred in one patient who considered to be infected.
underwent laminectomy and in three patients with When we examined our infection rates using the
cranial surgery, one of whom had a positive culture criteria of Malis (17) and of Wright (30), naturally, a
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In patients with contamination as a result of cranioplasties 2 years after the initial removal of the
trauma, a significantly higher infection rate was bone flaps.
found in patients with CSF fistulae (44%) than in the Our infection rate of 6.3% for shunt procedures is
other subgroups. The high infection rate of 44% in similar to that of most reported series (21), despite the
this subgroup of patients is not unexpected because fact that a large number of CSF shunts had been
CSF pathways were exposed to outside inserted in patients with postmeningitic
contamination. This is similar to the experience of hydrocephalus, tuberculous meningitis, or
Aarabi (1) in the Iran-Iraq war and of Meirowsky et al. hydrocephalus associated with myelomeningoceles.
(18)
in the Vietnam conflict. The overall rate of wound This protocol would allow for the rapid identification
sepsis in our patients with a compound skull fracture of risk factors, should an increasing rate of infection
or an open scalp wound was 3.1% which compares be identified in the clean category or in the clean with
favorably with results from other reported series foreign body category; then, appropriate infection
(Glasgow, 3.5%; Rotterdam, 5%; Pelonomie, 5.3%; control strategies can be instituted. There is an
and Brisbane, 7%) (25). increasing use of spinal instrumentation and the
In various series reporting on "clean" neurosurgical insertion of metallic rods, plates, and screws on a
procedures, subsequent operations were strongly permanent basis in neurosurgical practice. With this
implicated in sepsis (7,20,30). In Wright's (30) review of sepsis protocol, the effect of these materials on
clean craniotomies, the sepsis rate was found to have wound abnormalities can be further evaluated by the
increased if the same wound was explored again use of additional subcategories in the broad category
within a period of 4 weeks. Second operations for of "clean with foreign body."
gliomas are at the highest risk of developing sepsis Another example is that we identified that the
(24)
. Clearly, second episodes of surgery expose a repair of neural tube defects in neonates is an
surgical wound to increased contamination and additional risk factor when the clean category was
therefore should be categorized as contaminated evaluated. A high incidence of wound complications
cases. This is supported by the high infection rate in (22.4%) has been reported in the past in patients who
this category (11.8%) and is justified by the finding undergo repair of myelomeningoceles or
that there was no significant difference, on pairwise encephaloceles and has been ascribed to poor wound
testing, within the contaminated category itself. healing (5,8,11). Our sepsis rate in this group was
Several studies have also shown a direct link 14.8%. Associated hydrocephalus, with or without
between the development of postoperative sepsis and ventriculitis, or abnormal skin at the site of surgery
the length of surgery (5,10,20,24,30). Vlahov et al. (28), may be an associated aggravating factor (5,11). These
after examining their neurosurgical wound infection patients therefore fall into a different risk group and
rate, revealed a low infection rate for procedures need to be analyzed separately. After the exclusion of
taking less than 2 hours, with a steady increase up to this group from our clean category, the sepsis rate for
4 hours (24,30). Earlier, Wright (30) reported a similar "clean" cases fell to 0.8% (Table 7). The prevailing
trend in his series for craniotomies. Extended sepsis rate in our unit, before the introduction of this
exposure of the wound can lead to devitalization of protocol, ranged from 2 to 5% for previously
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ACKNOWLEDGMENTS in neurosurgery. A randomized controlled
We thank Dr. Jerzy Golek for assistance in trial. J Neurosurg 60:724-726, 1984.
preparation of the sepsis protocol, members of the 13. Guglielmo BJ, Hohn DC, Koo PJ, Hunt TK,
staff of the Department of Neurosurgery for Sweet RL, Conte JE Jr: Antibiotic prophylaxis
compiling data, Mrs. Cyndy McKeown and Mr. S. in surgical procedures. A critical analyses of
Naidoo for processing data, and Mrs. M. du Plooy for the literature. Arch Surg 118:943-954, 1983.
the preparation of the manuscript. 14. Haines SJ: Systematic antibiotic prophylaxis
in neurologic surgery. Neurosurgery 6:355-
Received, February 25, 1993. 361, 1980.
Accepted, September 27, 1993. 15. Haines SJ, Goodman ML: Antibiotic
Reprint requests: Dr. P.K. Narotam, Section of prophylaxis of postoperative neurosurgical
Neurosurgery, Dept. of Surgery, University of wound infection. J Neurosurg 56:103-105,
Arizona Health Sciences Center, Tucson, AZ 85724. 1982.
16. Lowbury EJL: Control of hospital infection,
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28. Vlahov D, Montgomery E, Tenney JH, Kahn- burr holes in cosmetically important sites? Is one burr
Eisenberg S: Neurosurgical wound infections: hole filled with acrylic more of a risk than one or two
Methodological and clinical factors affecting aneurysm clips? At this time, this is more a matter of
calculation of infection rates. J Neurosurg interest than of action, because we do not have a
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29. Winston KR: Hair and neurosurgery. preventive measures we use when the implantation of
Neurosurgery 31:320-329, 1992. a foreign body is carried out. Should such preventive
30. Wright L: A survey of possible etiologic measures be developed, however, it would be most
agents in postoperative craniotomy infections. important to know when they should be applied.
J Neurosurg 25:125-132, 1966. Therefore, the question of the volume and type of
31. Young RF, Lawner PM: Peri-operative foreign material implanted may be a useful area for
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Neurosurg 66:701-705, 1987. Stephen J. Haines
Minneapolis, Minnesota
COMMENTS
The authors have examined in a prospective study REFERENCES: (1-3)
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a foreign body beyond the size of an aneurysm clip or
a few wire sutures increases the risk of postoperative
wound infection from levels traditionally associated There is merit in revisiting well-established
with clean neurosurgical operations (1% or less) to guidelines that are accepted in day-to-day practice to
those associated with "clean contaminated" or determine whether there is a need for modifications.
"contaminated" wounds (5 to 10%). This occurs The authors of this communication have undertaken
despite the use of intraoperative antibiotic the onerous task of structuring a prospective protocol
prophylaxis. to analyze the relationship of postoperative sepsis to
The authors have dealt with one of the major a variety of wound conditions. They have
problems of such clinical studies of wound infection: accumulated sufficient numbers to achieve statistical
Norman H. Horwitz
Washington, District of Columbia
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Redistribution of this article permitted only in accordance with the publisher’s copyright provisions.
intracranial malignant gliomas. Neurosurgery
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Table 2. Analysis of Wound Infection after Surgical
Proceduresa
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Table 6. Analyses of Sepsis in Clean with Foreign
Body Category
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Table 9. Influence of Concurrent Infectionsa