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Acta Orthopaedica et Traumatologica Turcica 52 (2018) 289e293
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Acta Orthopaedica et Traumatologica Turcica

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The effectiveness of pedicle screw immersion in vancomycin and
ceftriaxone solution for the prevention of postoperative spinal
infection: A prospective comparative study

Burak Eren a, *, Feyza Karag€oz Güzey a, Serkan Kitiş b, Nezih €Ozkan c, Cafer Korkut d

a Health Sciences University, Ba�gcılar Training and Research Hospital, Department of Neurosurgery, _Istanbul, Turkey
b Bezmi Alem University, Department of Neurosurgery, _Istanbul, Turkey
c Acıbadem University Atakent Hospital, Department of Neurosurgery, _Istanbul, Turkey
d Health Sciences University, Ba�gcılar Training and Research Hospital, Department of Infectious Diseases, _Istanbul, Turkey
a r t i c l e i n f o

Article history:
Received 24 June 2017
Received in revised form
9 April 2018
Accepted 14 May 2018
Available online 7 June 2018

Keywords:
Spinal infection
Implant associated infections
Surgical site infection
Prevent infection
Local antibiotic
Prophylactic antibiotic
* Corresponding author. Merkez Mah, Mimar Sinan
Turkey. Fax: þ902124404242.

E-mail addresses: drburakeren@hotmail.com (B
(F. Karag€oz Güzey), serkankitis@yahoo.com (S. Kiti
(N. €Ozkan), cafer.korkut@hotmail.com (C. Korkut).

Peer review under responsibility of Turkish Asso
Traumatology.

https://doi.org/10.1016/j.aott.2018.05.004
1017-995X/© 2018 Turkish Association of Orthopaedic
(http://creativecommons.org/licenses/by-nc-nd/4.0/).
a b s t r a c t

Objective: The aim of this study was to evaluate the efficacy of the local application of vancomycin
hydrochloride (HCl)eceftriaxone disodium hemiheptahydrate onto implants before using them to pre-
vent postoperative infection.
Methods: The study included 239 patients (153 women and 86 men; mean age: 48.23 ± 16.77 years) who
had thoracolumbar stabilization with transpedicular screws. All surgeries were performed by the same
surgeon. Patients were divided into two groups. In the group 1 (n ¼ 104), implants were bathed in a so-
lution of local prophylactic antibiotics for 5 seconds just before implantation. In the group 2 (n ¼ 135),
implants were not bathed before implantation. Local antibiotics used in the study was effective against
gram positive bacteria (including methicillin resistant Staphylococcus aureus) and gram negative bacteria.
The rate of surgical site infection and wound healing time were compared between the groups.
Results: A total of 10 patients (4.1%) had deep wound infection and 20 (8.4%) had superficial infection.
The most common bacteria was Staphylococcus aureus. One patient died 21 days after the surgery
because of sepsis. The wound healed in a mean of 9.66 ± 2.04 days in patients who had no infection and
in 32.33 ± 19.64 days in patients with infection (p < 0.001). The patients in group 1 had significantly less
deep infection than the patients in group 2 (p < 0.05). However, there was no statistically significant
difference between the groups for superficial infection. Patients with vertebral fracture had significantly
lower deep infection rate in group 1. The deep infection rate of group 1 patients with diabetes, with
bleeding of more than 2000 mL, transfused with blood transfusions above 3 units and with dural injury
was significantly lower than those in the group 2. None of the patients had allergic reactions to the drugs
used for local prophylaxis.
Conclusions: This study shown that bathing implants in antibiotics solution was an effective local
prophylactic method to prevent deep infections in spinal surgeries with instrumentation.
Level of Evidence: Level III, Therapeutic study.
© 2018 Turkish Association of Orthopaedics and Traumatology. Publishing services by Elsevier B.V. This is
an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/

4.0/).
Cad. 6. Sok, Ba�gcılar, _Istanbul,

. Eren), fkarag@yahoo.com
ş), ozkannezih@hotmail.com

ciation of Orthopaedics and

s and Traumatology. Publishing se
Introduction

Surgical site infection (SSI) is a serious complication of spinal
surgery. It is reported in 0.7%e14% of patients who undergo spinal
surgeries involving instrumentation.1e8 SSI can be either superficial
or deep. If the infection extends under the paravertebral fascia, it is
defined as deep SSI. Deep SSI involves long hospital stays, repeated
surgeries, removal of the spinal implant and increased incidence of
developing pseudoarthrosis, resulting in high hospitalization costs.9
rvices by Elsevier B.V. This is an open access article under the CC BY-NC-ND license

http://creativecommons.org/licenses/by-nc-nd/4.0/
http://creativecommons.org/licenses/by-nc-nd/4.0/
mailto:drburakeren@hotmail.com
mailto:fkarag@yahoo.com
mailto:serkankitis@yahoo.com
mailto:ozkannezih@hotmail.com
mailto:cafer.korkut@hotmail.com
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B. Eren et al. / Acta Orthopaedica et Traumatologica Turcica 52 (2018) 289e293290
Microorganisms generally stick to the surface of spinal implants
and are, thus, transferred to the surgical site during surgery; in
addition, they may appear on implants in a case of permanent
bacteraemia after the surgery. Spinal implant surgeries are associ-
ated with an increased risk of infection owing to the bacterial bio-
film layer that grows on the surface of implants, which is resistant to
antibiotics.10 The gold standard in infection control is preventing
the development of SSI, which can be achieved by various methods.

This study primarily aimed to evaluate the efficacy of the
local application of vancomycin hydrochloride (HCl)eceftriaxone
disodium hemiheptahydrate onto implants prior to their use in
surgeries to prevent postoperative infection.
Material and methods

This prospective study was approved by the local ethics
committee of the hospital on 25 February 2006 (number
B.02.1.VGM.2.03.01). Written informed consent was obtained from
all patients. Patients who were treatment via posterior thor-
acolumbar stabilization with transpedicular screws and postero-
lateral fusion in our neurosurgery clinic were included in this study.
Between March 2006 and June 2009, 260 consecutive cases were
treated. Eighteen patients were excluded owing to a preoperative
diagnosis of spondylodiscitis or because of a known allergy to
some drugs, which were to be used in the study. In addition, three
patients were excluded because they did not follow-up. Therefore,
in total, 239 cases were included in this study.

Cefazolin sodium (1 gm) was intravenously injected in all the
patients 30 min prior to the skin incision. Furthermore, 1 g of
cefazolin sodium was postoperatively administered for 24 h (3 � 1,
every 8 h’’) for routine prophylaxis. The surgeries were all per-
formed by the same spinal surgeon. The fascia was closed with #1
polyglactin (MEDSORB PGLA®, Medeks, Istanbul, Turkey), the sub-
cutaneous tissue was closed with #2/0 polyglactin (PEGESORB®,
Fig. 1. To prepare the solution, a) The antibiotics powder are unpacked and, b) Dissolved in 2
before implantation.
Dogsan, Trabzon, Turkey) and the skin was closed with #2/0 poly-
propylene (PROP_ILEN®, Dogsan, Trabzon, Turkey) in all the patients.
A drain was placed in each patient that was removed on the first
postoperative day. In the hospital, the authors evaluated thewounds
daily until complete closure of the wound. Superficial and deep
infections were distinguished by a neurosurgeon along with a
specialist in infectious diseases based on examination andMRI with
contrast. In cases exhibiting flux from the surgery site, culture
samples were collected from the wounds andwere examined in our
microbiology laboratory. Both before surgery and one week after
surgery, blood glucose levels, white blood cell (WBC) counts, hae-
moglobin and haematocrit values, C-reactive protein (CRP) levels
and erythrocyte sedimentation rates (ESRs) were examined for each
patient. In addition, daily WBC, ESR and CRP levels were measured
in patients diagnosedwith an infection. All SSI cases were treated by
the author, who is an infectious disease specialist. Each SSI case was
followed from its diagnosis to wound healing, and the number of
days to reach complete wound healing was prospectively recorded
for all such cases. The patients were followed for an average of 1.2
years (range: 21 dayse3.5 years) for SSI.
Study groups

The broad-spectrum antibiotics for the local prophylaxis
solution were selected based on the microorganisms present at
the infection site (gram-positive bacteria including methicillin-
resistant Staphylococcus aureus and gram-negative bacteria). To
prepare the solution, vancomycin HCl (Edicin i.v. 500 mg 1 Flakon;
Sandoz, Istanbul, Turkey) powder and ceftriaxone disodium hem-
iheptahydrate (Cefaday i.v. 1000 mg 1 Flakon; Biofarma, Istanbul,
Turkey) powder were dissolved in 250 ml of saline (Fig. 1a and b).
The patients were divided into two groups. In group 1 (n¼ 104), the
implants were bathed in the local prophylactic antibiotics solution
for 5 s just before implantation (Fig. 1c). In group 2 (n ¼ 135), the
50 ml saline. c) Implants are bathed in the solution of local prophylactic antibiotics just



B. Eren et al. / Acta Orthopaedica et Traumatologica Turcica 52 (2018) 289e293 291
implants were applied without bathing them in local prophylactic
antibiotics solution. The patients were classified into the two
groups according to their preference for using the local antibiotics
solution during the operation. Patients who preferred local
antibiotics comprised group 1, whereas patients who did not prefer
the antibiotics solution comprised group 2 (control group).
Statistical analyses

The normality of the variables was assessed using a one-sample
KolmogoroveSmirnov test. Associations between SSI and potential
risk factors were analysed using chi-square and Fisher's exact
tests. Significant differences between continuous variables were
determined with the t-test or the ManneWhitney U test. A multi-
variate logistic regression analysis was used to identify independent
risk factors for SSI. A p value of <0.05 was considered as statistically
significant.
Results

This study included 239 patients (153 females and 86 males)
aged 48.23 ± 16.77 years old. In 26 patients (10.8%), additional
interventions were performed after the surgery for non-infectious
reasons. Screw revision was performed in nine patients in group 1
and in 11 patients in group 2. External lumbar drainage was per-
formed for cerebrospinal fluid (CSF) leakage in six patients (three in
group 1 and three in group 2), and three of these patients (one in
group 1 and two in group 2) underwent additional operation for
duraplasty.

Among all the patients, 10 (4.1%) had a deep wound infection
and 20 (8.4%) had a superficial infection. The average duration for
the development of the infection was 13.26 ± 10.96 days. Wound
debridement was performed in all patients with deep infection and
in four patients with superficial infection. Instrumentation systems
were removed in four cases with deep infection. One patient's
wound was closed with a paravertebral muscle flap. One patient
succumbed to sepsis after 21 days of the operation. Proper wound
Table 1
Risk factors for infection in the study groups.

Risk factor Group 1 (n ¼ 1

Age (years) 50.8 ± 14.2
Gender (F/M) 72(69%)/32 (31
Primary diagnoses (traumatic/non-traumatic) 28(27%)/76(73
BMI 209 ± 5.4
Diabetes mellitus (þ/�) 10(10%)/94(90
Smoking (þ/�) 15(14%)/89(86
Other concomitant diseases (þ/�) 44(42%)/60(58
ASIA grade (A-B/C-D-E) 4(4%)/100(96%
Preoperative glucose (mg/dl) 98 (58e246)
Preoperative Hb level (g/dl) 13 (4.6e16.8)
Preoperative hospitalization time (days) 9 (0e43)
Surgical category (emergent/elective) 10(10%)/94(90
Surgeryduration (h) 4 ± 1.1
N of instrumented segments (<5/�5) 91(88%)/13(12
Transfusion (>3 unit bag/�3 unit bag) 14(13%)/90(87
Dural injury (þ/�) 15(14%)/89(86
Postoperative ICU stay (þ/�) 16(15%)/88(85
Additional surgeries (þ/�) 12(12%)/92(88
Postoperative WBC count 8.3 (3.4e25.1)
Postoperative CRP level 0.9 (0.3e19.4)
Postoperative ESR level 60.5 (2e401)

Age, BMI and surgery duration data are presented as means±standard deviations. Da
postoperative WBC, CRP and ESR levels are presented as medians (ranges) and others ar
N, number; SD, standard deviation; BMI, body mass index; ASIA, American Spinal Injury
C-reactive protein; ESR, erythrocyte sedimentation rate.
closure observed in 9.66 ± 2.04 days in patients without infection
and in 32.33 ± 19.64 days in the patients with SSI (p < 0.001).

The postoperative WBC and ESR levels in the patients with
and without SSI were not statistically different. However, the
postoperative CRP levels in the patients with SSI were higher than
those in the patients without SSI (p < 0.001).

In 22 of 30 patients (73.3%), microorganisms were isolated from
the flux at the surgery sites. Multiple microorganisms were isolated
from 12 patients. The most commonly isolated bacteria was
S. aureus (n ¼ 10), followed by (in order of frequency of isolation)
Coagulase negative Staphylococcus, Pseudomonas aeruginosa, Acine-
tobacter baumannii, Enterobacter cloacae, Escherichia coli, Proteus
mirabilis, Enterococcus faecalis and Corynebacterium species.
Comparison of study groups and effects of local prophylactic
antibiotics

None of the patients demonstrated allergic reactions to the
drugs used for local prophylaxis. Moreover, there was no difference
between groups 1 and 2 regarding any of the studied characteristics
(demographic data, primary diagnoses, presence of concomitant
diseases, BMI, blood biochemistry and hospitalization and surgery
factors) (Table 1).

Nine patients developed SSI (only one developed deep SSI) in
group 1 (8.7%) and 21 patients developed SSI (ninewith deep SSI) in
group 2 (15.6%). The deep infection rate was significantly lower in
group 1 (0.96%) than in group 2 (6.6%) (p ¼ 0.04, OR ¼ 7.36).
However, there was no statistically significant difference between
the two groups with regard to the development of superficial SSI
(p ¼ 0.81, OR ¼ 1.17). All characteristics of the patients with deep
SSI are shown in Table 2.

The study groups were also compared based on the presence of
the following evaluated risk factors: primary diagnoses, presence of
concomitant diseases, amount of intraoperative bleeding and blood
transfusion and presence of an intraoperative dural injury. Patients
with a vertebral fracture in group 1 had a significantly lower
SSI rate than that in patients with a vertebral fracture in group 2
(p¼ 0.03). Patients with diabetes, thosewith >2000ml of bleeding,
04) Group 2 (n ¼ 135) p value

48 ± 14.9 0.13
%) 81(60%)/54 (40%) 0.14
%) 52(39%)/83(61%) 0.06

27.9 ± 5.2 0.10
%) 19(14%)/116(86%) 0.29
%) 28(21%)/107(79%) 0.20
%) 42(31%)/93(69%) 0.07
) 11(8%)/124(92%) 0.17

100 (56e383) 0.63
13.1 (8.2e17) 0.28
11 (0e48) 0.51

%) 13(10%)/122(90%) 0.99
3.8 ± 1 0.18

%) 121(90%)/14 (10%) 0.18
%) 15(11%)/120(89%) 0.58
%) 19(14%)/116(86%) 0.93
%) 12(9%)/123(91%) 0.12
%) 19(14%)/116(86%) 0.56

8.2 (1.7e19.5) 0.48
0.8 (0.3e19.3) 0.63
61 (2e120) 0.77

ta of preoperative glucose and Hb levels; preoperative hospitalization stays and
e presented as percentages. Significant p values are shown as bold characters.
Association; Hb, haemoglobin; ICU, intensive care unit; WBC, white blood cell; CRP,



Table 2
Characteristics of 10 patients with deep infections.

Age/Gender Primary Diagnosis Concomitant disease Surgery duration (hr) N of segments Study group Blood loss (ml) Implant removal

72/M Trauma þ 5 5 2 1200 e

61/F SL e 4 3 2 1800 þ
61/M LSS þ 5 2 2 2200 e

37/F SL e 2 2 2 500 þ
29/M Trauma þ 3 5 2 2500 þ
64/F SL þ 5 3 2 1300 e

63/F Tumour þ 8 5 2 2500 e

67/F LSS þ 3 2 1 700 e

39/M Tumour e 5 3 2 2800 e

35/F Trauma þ 4 5 2 1500 þ
N, number; SL, spondylolisthesis; LSS, lumbar spinal stenosis.

B. Eren et al. / Acta Orthopaedica et Traumatologica Turcica 52 (2018) 289e293292
those who were transfused with >3 units of blood and those with a
dural injury had lower SSI rates in group 1 than in group 2 (p¼ 0.03,
p ¼ 0.026, p ¼ 0.016 and p < 0.001, respectively). However, there
were no intergroup differences with respect to low ASIA score,
presence of chronic illnesses except diabetes mellitus and number
of instrumented segments (p ¼ 0.17, p ¼ 0.93 and p ¼ 0.6,
respectively).

Discussion

Infection is the most common complication of spinal surgeries.
SSI prolongs the patient's hospital stay and increases morbidity and
mortality. Superficial infections typically progress mildly, but deep
wound infections can lead to spondylodiscitis, osteomyelitis and
meningitis.11 Furthermore, the frequency of SSI is high after spinal
surgeries that involve instrumentation.9 Rechtine et al12 ascer-
tained that the rate of SSI for thoracolumbar trauma surgeries was
10% in 235 cases. Jutte and Castelein13 reported a deep infection
rate of 4.7% in 105 patients whowere operated using underwent an
operation involving pedicle screws. This rate was lower in our
study. The treatment of patients with deep postoperative infections
is expensive; moreover, the patient's length of stay in the hospital
increases, preventing them from resuming work, and further
increasing indirect costs.14 Deep wound infections might also lead
to sepsis and death, as shown in our research.11

According to this study, postoperative CRP levels were reliable
indicators of infection. However, we could not identify a connection
between high postoperative ESR levels and the presence of an SSI.
CRP is more sensitive than ESR when evaluating the response to
infection treatment.15e17

Reportedly, the most common causative microorganisms of SSI
are S. aureus and other members of Staphylococcus species.12,17,18

Chen et al19 also reported that members of the Staphylococcus
species were themost common causative agents of SSI and that they
were isolated from 58.3% of cases. In our study, the most commonly
isolated organism was also S. aureus. On the contrary, the rate of
negative cultures in our study was high (26.7%), similar to that
observed in the study by Gerometta et al20 (0e31.4%).

Prophylaxis for infection and other protective procedures

Under the paravertebral fascia, foreign bodies and local tissue
necrosis of paravertebral soft tissues, such as postoperative hae-
matoma or intervertebral discs, create an optimum medium for
microorganism growth. During surgery, microorganisms present
in the air of the operating room can enter the wound and stick to
the implants. In a prospective study that included patients who
were operated in the same operating room and by the same sur-
geon, Gelalis et al21 reported that the culture samples collected
intraoperatively from the surgical wounds showed a 20% growth.
Moreover, the development of biofilms on the surfaces of implants
plays an important role in implant-associated infections because of
the biofilm's protective effect on microorganisms against the host
defence systems and antibiotics. This biofilm layer covers the sur-
faces of implants and neighbouring host tissues. The biofilm layer
contains fibronectin, fibrinogen, collagen and other proteins.
Glycocalyx-coatedmicrocolonies are often protected from the host-
tissue defences.4 Extracellular DNA is amajor structural component
of the S. aureus biofilm matrix. Bacterial proteases cause the release
of extracellular DNA, which is critical for the early development of
biofilms.22 Literature suggests that biocompatibility and physical/
chemical properties of implants can be contributing factors for the
differences in infection rates, especially with metal implants that
have smooth and rough surfaces.23,24 All of these studies showed
the importance of intraoperative SSI prevention.

Many studies have evaluated the effects of local antibiotics or
antimicrobials on the development of postoperative wound in-
fections. In a study by Brennan et al,25 the antimicrobial outcomes of
silver-coated implants were good, with a low proportion of positive
cultures and low rates of osteomyelitis. Similarly, another study
observed that silver-coated titanium implants can be used to prevent
implant-associated deep bone infections.26 However, these types of
implants are quite expensive and pose some risks due to silver
intoxication.27 Another cost-effective method involves bathing the
implants in a povidone-iodine solution before implantation.28

Some studies demonstrated that the use of local antibiotics was
less risky and cheaper treatment option. In a study conducted with
218 rats, Perdue et al29 reported that they performed peritoneal
lavage using a saline solution with ceftriaxone and successfully
treated peritonitis. Themost studied antibiotic for local prophylaxis
is vancomycin, which is the effective against the most frequently
cultured microorganisms from Staphylococcus species. Some clin-
ical studies have reported that the rate of deep wound infection
reduced following the use of local prophylactic intraoperative
powdered vancomycin.30,31 In addition, other antibiotics have been
reported in the literature. In a rabbit model, Stall et al32 cured twice
as many infections using polylacticoglycolic acid microspheres
saturated with gentamicin than using a placebo. Conversely, the
local use of antibiotics and antimicrobials may cause serious com-
plications. Blas et al33 reported anaphylaxis due to bacitracin irri-
gation before closing the wound. In our study, a solution that
contained broad-spectrum antibiotics, which were effective on the
most common microorganisms causing SSI in our clinic, such as
gram-positive bacteria including methicillin-resistant S. aureus and
gram-negative bacteria, was locally applied on the implants before
implantation. Thus, the surfaces of screws and other parts of in-
struments were coated with broad-spectrum antibiotics. A com-
parison between the patient groups demonstrated that bathing the
implants in a prophylactic antibiotic solution prevented deep in-
fections. This reliable method is cost-effective and easy to use.



B. Eren et al. / Acta Orthopaedica et Traumatologica Turcica 52 (2018) 289e293 293
Furthermore, in this study, none of the patients who received local
antibiotic prophylaxis experienced an allergic reaction.

CSF leakage, smoking, obesity, diabetes, HT and blood trans-
fusions are the risk factors associated with SSI.2 In diabetic patients,
local changes in the tissues increased the risk of infection. A pre-
vious study reported that diabetic patients had a 10%e20.9% rate of
SSI.4 However, in our study, diabetic patients were protected from
deep SSI in group 2. Moreover, vertebral fractures lead to a high rate
of SSI.19 Moreover, excessive amount of blood loss and transfusions
were reported as risk factors for infection development.9 However,
another study did not observe an increase in infection risk with a
loss of �1500 ml of blood.1 Reportedly, with the use of local anti-
biotics, the concentration of antibiotics at the operation site is
higher than systemic application.34 In our study, we observed that
the local use of antibiotics had protective action against deep in-
fections in patients with fractures and in patients who had too
much blood transfused due to excessive bleeding. In a meta-
analysis, Khan et al35 defended the local use of vancomycin pow-
der that might have a protective action against SSI; however, they
recommended its use only in high-risk patients. By contrast, Suh
et al36 suggested that this method was not successful in preventing
SSI. Conversely, in another study, vancomycin-impregnated fibrin
sealant use was successful in preventing SSI.37

The limitations of this study include the high rate of infection,
the fact that it was not effective in some high-risk groups and the
simultaneous use of two antibiotics. In particular, the high rate of
superficial infection relative to other studies may have affected the
outcomes of this study. However, unlike our study, only deep
infection rates were reported in most previous studies, and
superficial infections were not mentioned.2,13,30,35 Moreover, the
efficacy might vary if the doses of antibiotics or the amount of
saline changes.

Conclusion

This prospective study proposes a novel suggestion for the pre-
vention of deep spinal infection. Bathing implants in vancomycin HCl
and ceftriaxone disodium hemiheptahydrate solution before their
application is an effective local prophylactic method in spinal sur-
gerieswith instrumentation. Thismethod appears to be an interesting
alternative that requires further prospective and randomized studies.

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	The effectiveness of pedicle screw immersion in vancomycin and ceftriaxone solution for the prevention of postoperative spi ...
	Introduction
	Material and methods
	Study groups
	Statistical analyses

	Results
	Comparison of study groups and effects of local prophylactic antibiotics

	Discussion
	Prophylaxis for infection and other protective procedures

	Conclusion
	References