Prophylaxis in cardiac surgery.

A controlled randomized comparison between cefazolin

and cefuroxime
F Wellens, M Pirlet, R Larbuisson, F De Meireleire and P De Somer
Eur J Cardiothorac Surg 1995;9:325-329

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The European Journal of Cardio-thoracic Surgery is the official Journal of the European Association for
Cardio-thoracic Surgery and the European Society of Thoracic Surgeons. Copyright © 1995 by European
Association for Cardio-Thoracic Surgery. Published by Elsevier. All rights reserved. Print ISSN: 1010-7940.

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 - - • European Journal of
Eur J Cardio-thorac Surg (1995) 9 : 3 2 5 - 3 2 9
CardiOthoracic
Surgery © Sprmger-Verlag 1995

Prophylaxis in cardiac surgery

A controlled randomized comparison between cefazolin and cefuroxime
F. Wellens 2, M. Pirlet 2, R. Larbuisson a, F. De Meireleire 3, P. De Somer 1
1 Department of Cardiac Surgery, Onze Lleve Vrouwmekenhuis, Moorselbaan 164, 9300 Aalst, Belgium
2 Department of Anesthesia, Centre Hospitalier Unlversitalre du Sart Tilman. Liege, Belgium
3 Department of Infectious Diseases, Onze Lieve Vrouwziekenhuis, Moorselhaan 164, 9300 Aalst, Belgium

Abstract. In a prospective randomized two center trial, short-term prophylaxis with cefuroxime (CFX) in 189 pa-
tients was compared with cefazolin (CFZ) in 196 patients submitted to elective cardiac surgery. A total of 3 g was
administered over 24 h in both groups. One major adverse reaction with CFX was noted. Patients were prospec-
tively screened by infectious disease nurses for surgical wound and secondary infections. Sternal wound infec-
tions occurred in eight patients treated with CFX and all were minor. One patient from this group eventually died
of infectious causes. In the CFZ-treated patients two major and six minor wound infections occurred requiring
extensive debridement in two. Secondary infections occurred less frequently in the CFX group (13.2 per 100) than
in the CFZ group (16.8 per 100) with two infection-related deaths in the CFX and one in the CFZ group. The most
commonly identified organisms were Staphylococcus aureus and a variety of gram-negative organisms. No major
differences were observed between the CFX and CFZ groups. Short-term administration of 3 g CFZ or CFX in
this study could not demonstrate the advantage of one of the antibiotics used over the other in terms of clinical
outcome, incidence or site of infection or organisms identified. The 24 h administration of 3 g CFZ or CFX pro-
vided suboptimal prophylaxis for wound infection or secondary infections in patients undergoing elective open
heart surgery. [Eur J Cardio-thorac Surg (1995) 9: 325-329]

Key words: Cardiac surgery - Infection - Antibiotics - Prophylaxis - Sternum

The possible life-threatening consequence of infection in
patients undergoing cardiac surgery justifies the prophy-
lactic use of antibiotics [1, 3, 7, 10, 19]. The organisms
causing infectious problems after cardiac procedures are
equally divided between Staphylococcal species and En-
terobacteriaceae, although the proportion of each varies
considerably from study to study. Several antibiotics have
been evaluated for prophylaxis and especially the cepha-
losporins are very frequently used because of their spec-
trum of activity, pharmacokinetic profile and the lack of
major toxicity. Cefazolin (CFZ), one of the first cephalos-
porins available, has been a popular choice for prophylac-
tic therapy among cardiovascular surgeons [ l 7]. However,
the increasing prevalence of resistance of gram-negative
bacilli has encouraged investigators to evaluate second
generation cephalosporins such as cefuroxime (CFX) [2.
5, 8, 11]. Several authors [2, 8, 13, 15, 17] have suggested
better efficacy in preventing postoperative wound infec-
tion with CFX and cefamandole than with CFZ in cardio-
Received for publication: March 2. 1994
Accepted for publication: January 10. 1995
Correspondence to: E Wellens. M. D.
vascular surgery. With the exception of the recent study of
Doebbeling and co-workers [5], few comparisons have
been made between the prophylactic use of CFX and CFZ.
The changing patterns of the patient population in two
tertiary referral centers (as in other open heart surgery pro-
grams [4]), the extensive use of one or both internal tho-
racic arteries in recent years with increased morbidity of
sternal infections [15] and the controversial results with
various antibiotics in the literature were the reasons for
starting a prospective randomized trial comparing the ef-
ficacy of CFX and CFZ in preventing postoperative infec-
tions in open heart surgery.
Patients and methods
Patient selection
Patients over 18 years of age admitted for elective coronary artery
bypass grafting, cardiac valve replacement or reconstruction and
simple congenital lntracar&ac repair were considered to receive
CFX or CFZ antibiotic prophylaxis in this randomized trial. All pro-
cedures were performed at the Onze Lieve Vrouw Ziekenhuis Aalst
and at the University Hospital of Liege Belgium over a period of

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326
1 year. To be included in the study the patients could have neither
hypersensivity to cephalosporins, nor fever of more than 38 °C. Pre-
vious antibiotic treatment within 3 days before admission, hospital
admission exceeding 36 h before operation and immunocomprom-
ised patients (less than 1000 polymorphonuclear neutrophils) were
absolute exclusion criteria.
Study design
A non-blind randomized comparison of 24 h prophylaxis with CFX
versus CFZ was carried out in two groups of 200 evaluable patients.
Four hundred patients had to be included in the study in order to al-
low a 50% reduction of the infection rate when starting with the hy-
pothesis of 14% infection rate and a study power of 80%. A series
of scaled numbered envelopes, containing the treatment allocation
was used. The envelopes were opened in numerical order, one for
each patient after inclusion in the study. Randomization was carried
out in advance for the whole group by a computer program for se-
ries of 200 patients.
Study medication
Both CFX and CFZ were administered in bolus during the first op-
erative day. Cefuroxime was given intravenously at a total dosage
of 3 g divided in two injections of 1.5 g. The first injection of CFX
was administered at the induction of anesthesia. The second dosage
was given 12 h later on the intensive care unit. Cefazolin was ad-
ministered intravenously at a total dosage of 3 g divided in three in-
jections of 1 g. The first injection was administered at the induction
of anesthesia. The second and third injections of 1 g CFZ were giv-
en, respectively, 8 and 16 h later.
Clinical evaluation and surveillance
Patients had a full clinical examination the day before operation and
clinical assessment was carried out daily during the hospitalization
period by one of the cardiovascular (CV) staff surgeons, and separ-
ately by the infections disease room nurses (RN) assigned to the
study. An individual study book was used for each patient and data
were entered on a day-to-day basis. Skin preparation was carried out
with povidone iodine the evening before operation and with iodine
solution intraoperatively. After hospital discharge patients were re-
viewed at the outpatient clinic by the staff CV surgeon and RN re-
sponsible for the study between 4 to 6 weeks postoperatively, or ear-
her in case of infection problem.
Rectal temperature was measured twice daily during hospitaliza-
tion. A safety screen covering hematology (red blood cells, haemog-
lobin, haematocrit, platelet count, prothrombin time and differential
white cell count and sedimentation rates), biochemistry (liver func-
tion, blood urea nitrogen, serum creatinine and clearance) and urine
analysis (PH, density, biochemistry and microscopy and culture),
was performed within 24 h before the operation, between 24
and 48 h postoperatively and on the day of follow-up when ab-
normal values which could be antibiotic related were noticed
after the second postoperative day. Creactive protein was not mon-
itored. Bacteriologic assessment was carried out on appropriate
samples collected for culture and sensitivity when infection was sus-
pected.
Disc sensitivity of the isolates was tested agmnst CFZ and CFX
and a standard range of antibiotics including ampicillin, cephalotm,
piperacillin, gentamycln and cefotaxlme. All adverse events after
administration of the antibiotic were registered,
Criteria for diagnosing infection
If, after 48 h postoperatively, two consecutive rectal temperature
readings were more than 38.0 °C infection was suspected. Wound
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infection referred to the presence of pus in the wound and seventy
of wound infection was characterized as follows:
grade 1 : disturbed wound healing
grade 2 : redness <1 cm from the incision
grade 3 : suture pus
grade 4 : wound dehiscence and
grade 5 : wound edge necrosis, concomitant osteomyelitls
and/or mediastmitls.
Grades 4 and 5 were considered as major infections.
Pulmonary infection was diagnosed in the presence of at least
two of the following criteria: fever more than 38 °C, the presence of
purulent sputum and radiologic evidence of infection or a sputum
culture positive for organisms others than normal flora. Urinary tract
infection was diagnosed on the finding of more than 106 organ-
isms/ml in a mid-stream urine sample or at least two of the follow-
ing symptoms: a temperature higher than 38 °C, abnormal sediment
and clinical signs and symptoms. Gastrointestinal infection was di-
agnosed in the presence of positive stool culture and diarrhea. Sep-
ticemia was diagnosed in the presence of a rectal temperature high-
er than 38 °C and positive blood culture.
Infections were divided according to their location: wound (ster-
num + leg) versus secondary infections (blood, lungs, gastrointesti-
nal and urinary tract), and according to the time of onset: infections
were considered early when they occurred within the first 2 weeks
after the operation.
Statistical analysis
All statistical tests were carried out two-tailed at the 5 % level of sig-
nificance. The calculations were performed using the statistical
package SPSS/PC+ on an IBM compatible microcomputer. For the
comparison of continuous variables in the two treatment groups both
the t-test and the Mann-Whitueytest were used. For the discrete var-
iables chi-squared or Fisher exact tests were used. For the relation-
ship between continuous variables and several discrete variables
(e.g. between the day of onset of the infection and the treatment, the
occurrence of an infection and the center) the analysis of variance
was applied (ANOVA),
Results
F r o m the 401 patients enrolled in this trial 385 record
forms were f o u n d to be evaluable, 196 (51%) in the C F Z
treatment group and 189 (49%) in the C F X treatment
group. Sixteen patients (4%) were excluded for the fol-
l o w i n g reasons: five patients died w i t h i n the first 3 post-
operative days of n o n - i n f e c t i o n causes, ten patients were
excluded for major protocol violations and one patient had
a m a j o r adverse e v e n t at the time o f operation.
F r o m the 385 e v a l u a b l e patients, 296 were admitted to
the hospital for coronary artery bypass grafting, 66 pa-
tients for cardiac valve replacement, 18 patients for com-
b i n e d procedures and 5 patients for atrial septal defect clo-
sure. No significant differences in operative characteris-
tics or hospital stay were observed a m o n g the patients as-
signed to the two treatment groups (Table 1). The average
age of the patients was 60.5 years range: 2 0 - 8 2 . Except
for a difference in hospital stay, no differences were f o u n d
b e t w e e n the patient p o p u l a t i o n s of the two study centers.
E v a l u a t i o n of safety was performed for 395 patients.
Only one adverse event which was possibly related to the
trial drug was reported in this trial: severe h y p o t e n s i o n
with v e n t r i c u l a r fibrillation occurred after injection of
 327
Table 1. Baseline and operative characteristics and hospital stay in Table 3. Late infections
two groups treated wxth esther CFX or CFZ
Number of patients with CFX group CFZ group
Cefuroxlme Cefazolin problems at follow-up
(N= 189) (N= 196)
Total number 18 22
Age (years) 60.7 _+9.9 60.4 _+9.0 Related to the operation 9 13
Weight (kg) 72.5 + 12 74.0 + 11.7 Reqmring antibiotics 9 9
Height (era) 168.2 + 8.4 169.2 + 8.2
Temperature 36.2 _+0.3 36.3 _+0.3 Related to the operation 6 9
before operation (°C) and requiring antibiotics
Duration of operation (rain) 220.4 + 51.2 229.5 + 55.3
Blood loss (cc) 901.5 + 640.8 900.8 _ 492.3
Hospital stay (days) 13.4 + 4.9 13.6 + 5.2 eventually died from multiorgan failure. One leg wound
infection but 22 secondary infections were registered in
Operative indication (%, no in brackets) the CFX group. One patient died from sepsis caused by an
- CABG 36.8% (142) 39.5% (154) intra-abdominal abscess.
-Valveprocedure 9.6% (37) 7.5% (29) In the CFZ group 34 infections were noted in 28 pa-
- CABG+valve 18% (7) 2.8% (11)
- Congenital 0.8% (3) 0.5% (2) tients (14.2% of the group). Twenty-two patients needed
antibiotic treatment. One patient developed a major ster-
Mean values + standard deviation nal wound infection and two others a minor sternal wound
problem. Thirty secondary infections were noted, with one
death in a patient with a pulmonary infection. For 13 other
Table 2. Early postoperative infections patients a delay in hospital discharge was directly related
to the infection.
Infection site CFX group CFZ group Total
(n = 189) (n= 1 9 6 ) (n=385) Significant differences could not be concluded between
the two treatment groups for any of the types of infections
No. Death No. Death No. (Fisher test or chi-squared test). Another evaluation of ef-
ficacy was carried out by comparing the average hospital
Sternal wound stay in the two treatment groups. The duration of the post-
major 0 1 operative period, i.e. days between day of operation and
minor 5 1 2
Leg wound 1 1 2 day of discharge, was 11.53 + 5.05 days in the CFX group
Pulmonary infection 9 14 23 (range: 2-49 days) and 11.66 + 5.32 days in the CFZ group
Urinary tract infection 5 7 12 (range: 7-47 days). Both the t-test and the Mann-Whitney
Septicemia 4 1 8 12 test yielded non-significant differences between the two
Catheter sepsis 3 1 4 treatment groups. Another means to control efficacy was
Other the analysis of the evolution of body temperature. Com-
Total infections 27 34 61 parison of the actual or maximal temperatures yielded non-
No. infected patients 20 2 28 1 48 significant results (t-test and Mann-Whitney test).
(10.6%) (14.2%) (12.5%) After discharge 40 patients had an infectious problem,
in 22 it was operation-related (Table 3). Six patients from
the CFX group and nine patients from the CFZ group re-
CFX at the time of induction of anesthesia. From the quired antibiotics. Late sternal wound infections occurred
401 patients recruited for this study 11 (2.7%) patients in three patients in the CFX group and in five in the CFZ
died, 5 in the CFZ group and 6 in the CFX group. In the group, one of them being classified as major. Secondary
CFX group three patients died because of infection, in the infections occurred on four occasions in the CFX group
CFZ group one patient died as a result of pneumonia (Ta- and on 2 in the CFZ group. Leg wound infections occurred
ble 2). The other deaths were not related to any infections; in six patients in the CFZ-treated group and in two in the
five of them were excluded from the further trial as they CFX group (Table 4).
died within 3 days after the operation from non-infectious The distribution of bacterial species responsible for the
causes. early onset infections is outlined in Table 5. In the CFX
Early infection, i.e. within 2 weeks postoperatively, oc- group 30, and in the CFZ group 33 positive cultures were
curred in 48 patients (Table 2). Twelve patients had two registered. There was a similarity noted for gram-positive
or more infection sites, of whom 5 presented with identi- cocci as well as for gram-negative bacilli.
cal germs at their multiple infectious sites. A delay in hos- In order to investigate whether the variable age, weight
pital discharge was noticed in 24 patients (50%). and duration of operation, blood loss and hospital stay were
In the CFX group 27 infections occurred in 20 patients related to the occurrence of a post-surgical infection, three-
(10.6%). Fifteen patients had to be treated with antibio- way ANOVAS were carried out. This analysis failed to
tics. Two deaths were directly infection-related. Ten other demonstrate any relation between the tested parameters
patients had a delay in hospital discharge. None of the CFX and the occurrence of infection. On the other hand, there
patients developed a major sternal wound infection. One was a highly significant relationship between the occur-
of the five patients with minor sternal wound infections rence of a postoperative infection and a prolonged hospi-
also developed pulmonary and urinary tract infection and tal stay in this subset of patients.

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328
Table 4. Late infections therefore seemed reasonable to compare CFX to the cur-
rently used CFZ antibiotic prophylaxis. From the results
Infection site Cefuroxime (n = 183) Cefazolin (n=191)
+ AB + AB obtained from this selective study population we could not
demonstrate the advantage of either of the antibiotics used.
Sternal wound: major 0 0 1 1 Sternal wound infections occurred in 16 patients; eight
minor 3 0 4 2 of them in the first 2 weeks after the operation (CFX: five
Leg wound 2 2 6 4 and CFZ three) and eight in the late phase (CFX three and
Pulmonary tract 2 2 0 0
Urinary tract 2 2 2 2 CFZ five). However the only two major sternal infections
Other 0 0 0 0 occurred in the CFZ group. Both patients needed exten-
Total number of patients 9 6 13 9 sive debridement and eventually healed. Only one patient
(4.9%) (6.8%) with a minor wound infection from the CFX group died
from infectious problems as he presented several infec-
AB, antlbiotm treatment tious sites with the same germs and succumbed from mul-
tiorgan failure. Leg wound complications were all minor
Table 5. Organisms responsible for infection and most were seen at the first outpatient clinic control.
However, six out of eight patients had received antibiotic
Cefnroxlme Cefazolin
treatment from their family physician; the same observa-
Gram + tion was also made by Miedzinski [15].
Staphylococcu~ aureus 4 5 This total of 26 surgical infections (15 in the CFZ group
Staphylococcus szmulans 1 0 and 11 in the CFX group) represents a 6.7% infection rate
Staphylococcus epidermidts 3 4 for the entire study population. Farrington [6] and Wells
Streptococcus pneumoniae 0 2
[ 18] reported a higher infection rate and Slama [ 17] a lower
Streptococcus haemol, gr C 1 0
Streptococcus faecalis 1 3 total infection rate than our results. The results of the re-
Corynebacterium species 1 - cent report by Doebbeling and co-workers [5] who per-
Anaerobic Streptococcus 1 - formed a prospective double-blind comparison of CFZ and
CFX were nearly identical to ours. In their study Doebbel-
12 14
ing and co-workers [15] found that CFZ was much more
Gram - efficient in preventing sternal wound infections than CFX.
Eschertchia colt 2 3 It is important to notice, however, that the two patients
Klebs tella oxytoca 1 2
who needed surgical intervention for sternal wound infec-
Klebsiella pneumomae 4 1
Haemophilus mfluenzae 1 4 tion in our study were both from the CFZ group.
Enterobacter cloacae 4 2 Although the patient selection and the diagnosis of in-
Serratta marcescens 4 1 fection in our study and that of Doebbeling were very sim-
Pseudomonas aerugmosa 0 4 ilar, there are some important differences between the two
Proteus mirabihs 0 2
Salmonella 1 0 studies in terms of the number of patients, the fact that our
Acinetobacter 1 study was an open study and, mainly, in the duration of
antibiotic treatment: as we only administered antibiotic
18 19 prophylaxis for 24 h while they gave it for 48 h. Appar-
Total 30 33 ently this did not increase the number of surgical infec-
tions compared to the series of Doebbeling et al. [5]. This
short antibiotic course did not even influence the incidence
Discussion of nosocomial infections when comparing the two studies
or others [11, 12]. In Doebbeling's study nosocomial in-
This study was undertaken to test the possible adve,ntage fections accounted for 16.3 and 19.3% in the CFZ and CFX
of CFX over CFZ in the prevention of postoperative wound groups, respectively, while in our study we found 16.3 and
and secondary infections after open heart surgery. 13.7%, respectively.
The study of Slama and co-workers (17) was a pros- In our study it is important to notice that this short-course
pective randomized study comparing cefamandole, CFX antibiotic treatment was insufficient to protect a number of
and CFZ as antibiotic prophylaxes in 300 patients over patients from multiple infection sites, which means a total
48 h. The results were not favorable for intravenous (IV) failure of the antibiotic coverage. Indeed in the early post-
CFZ, with the highest rate in total and wound infections. operative infections (Table 2) we noticed that 28 infections
Cefazolin was used as the standard prophylaxis in the two occurred in only 20 patients in the CFX group and 34 in-
cardiac institutions involved in this study. The rapid fections in only 24 patients in the CFZ group. Five patients
change in patient demographics with older patients, more presented the same micro-organism in wound and blood
emergency operations and the extensive use of the intra- cultures suggesting that early wound infection caused sec-
thoracic artery over the last years were all reasons to ex- ondary septicemia. No case of native or prosthetic endo-
pect more infections, together with an increase in early carditis was observed in the entire study population.
morbidity and mortality. Peterson and co-workers [ 16] and Surgical wound and nosocomial infections have been
Geroulanos and co-workers [9] stated that CFX was as ef- studied in most studies on antibiotic prophylaxis. How-
fective as cefamandole in open heart surgery. In addition ever the efficacy of an individual antibiotic on each type
CFX was less costly and had a less frequent dosage. It of infection should be studied separately as patient-related

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factors are probably more important in a subset of secon-
dary infections. Due to the discrepancy in patient selec-
tion, study design, duration of antibiotic administration
and diagnosis of infection, comparison of our study results
with those of Gentry [8], Slama [17] and Geroulanos [9],
is more hazardous and of less value.
Another observation from our study was the prevalence
of gram-negative organisms present in the surgical wound
as well as in the nosocomial infections. Often a combina-
tion was found of both gram-positive and -negative organ-
isms. Indeed, the frequency of enterobacteriacae also sug-
gests that nonantibiotic measures have to be intensified
[14]. It leads us to the question of whether we have to use
wider spectrum antibiotics in the early postoperative phase
or if we have to limit ourselves to an adequate gram-pos-
itive coverage in order to avoid a rapid change in the
patient's bacteriologic household.
Even if one keeps to the choice of first or second gen-
eration cephalosporins we have to take into account the lo-
cal bacteriologic profile of every institution. Recently we
could observe an important increase in isolates of Staph-
yloccocus epidermidis resistant to methicillin. Continuous
collaboration with the Infectious Disease Department is
mandatory to adapt antibiotic prophylaxis to the changing
institutional bacteriologic profile.
In view of the increasing demands put on the cardiac
surgical teams and the devastating consequences of surgi-
cal sternal and/or mediastinal infections, one has to focus
not only on efficient antibiotic perioperative coverage but
even more on the classical rules of surgical asepsis and
meticulous surgical techniques as recently advocated by
Loop and co-workers [14]. More attention must also be
given to ICU infectious surveillance and fast retrieval of
indwelling catheters.
Economic considerations do not play an important role
in the choice between CFX and CFZ as the price per 24 h
dosage in nearly identical. Due to the short administration
of both antibiotics, any difference in administering costs
was negligible in our study. In contrast, delay in hospital
discharge due to infection was obvious in both groups. The
economic impact of prolonged hospitalization is much
more important than the small variation of cost due to dos-
age, short- or medium-term use or administrative costs.
In conclusion, this randomized controlled study could
not demonstrate the advantage of one of the antibiotics
used over the other in open heart surgery prophylaxis. They
were both good in preventing major wound infections,
while the incidence of minor wound and secondary infec-
tions was high. In view of these results we have to face the
fact that none of the cephalosporins used can provide the
cardiac surgeon with a highly effective protection against
all surgical or secondary infections. Further research and
evaluation of newer antibiotics together with more strin-
gent local and surgical technical measures will be the only
way to reduce the devastating consequences of infections
in open heart surgery.
Acknowledgements.The authors would like to thank L. Kaufman
and M.R Derde (Biostatistics, FASC, Free University Brussels) for
the statistical analysis. The study was supported by a grant from
GLAXO, Belgium.
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329
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Prophylaxis in cardiac surgery. A controlled randomized comparison between cefazolin
and cefuroxime
F Wellens, M Pirlet, R Larbuisson, F De Meireleire and P De Somer
Eur J Cardiothorac Surg 1995;9:325-329
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