Novel approach to antibiotic prophylaxis in percutaneous endoscopic gastrostomy (PEG): randomised controlled trial.
ABSTRACT To evaluate a new and simpler strategy of antibiotic prophylaxis in percutaneous endoscopic gastrostomy (PEG).
Single centre, two arm, randomised, controlled, double blind clinical trial.
Endoscopy unit in Karolinska University Hospital, Stockholm, Sweden, between 3 June 2005 and 31 October 2009.
234 patients with an indication for PEG who gave informed consent to participate.
A single 20 ml dose of the oral solution of sulfamethoxazole and trimethoprim (also known as co-trimoxazole or Bactrim; F Hoffmann-La Roche Ltd, Basel, Switzerland) deposited in the PEG catheter immediately after insertion. The control group received standard prophylaxis consisting of a single intravenous dose of 1.5 g cefuroxime (Zinacef; GlaxoSmithKline, London) administered before insertion of the PEG tube.
Primary outcome was the occurrence of clinically evident wound infection within 14 days after insertion of the PEG catheter. Secondary outcomes were positive bacterial culture and blood tests (highly sensitive C reactive protein and white blood cell count). All randomised patients were included in an intention to treat analysis.
Of the 234 patients included in this study, 116 were randomly assigned to co-trimoxazole and 118 to cefuroxime. At follow-up 7-14 days after insertion of the PEG catheter, wound infection was found in 10 (8.6%) patients in the co-trimoxazole group and 14 (11.9%) in the cefuroxime group, which corresponds to a percentage point difference of -3.3% (95% confidence interval -10.9% to 4.5%). The per protocol analysis, which comprised 100 patients in each group, gave similar results-10% and 13% infection in the co-trimoxazole and cefuroxime groups, respectively (percentage point difference -3.0%, 95% CI -11.8% to 5.8%). Both these analyses indicate non-inferiority of co-trimoxazole compared with cefuroxime because the upper bounds of the confidence intervals are lower than the pre-determined non-inferiority margin of 15%. Analyses of the secondary outcomes supported this finding.
20 ml of co-trimoxazole solution deposited in a newly inserted PEG catheter is at least as effective as cefuroxime prophylaxis given intravenously before PEG at preventing wound infections in patients undergoing PEG. Trial registration Current Controlled Trials ISRCTN18677736.
Article: Efficacy of 48-hour post-operative antibiotics prophylaxis for patients undergoing percutaneous endoscopic gastrostomy tube in preventing site infection.[show abstract] [hide abstract]
ABSTRACT: Percutaneous Endoscopic Gastrostomy (PEG) is an endoscopic procedure for placing a feeding tube into the stomach through the skin, primarily to avoid malnutrition. Malnutrition can increase the risk of wound infection, whose incidence can be decreased by using antibiotic prophylaxis. The purpose of our study was to evaluate the efficacy of a new antibiotic regimen in preventing acute post-PEG procedure complications. Ninety-seven consecutive patients were put on combined antibiotic therapy of clindamycin 600 mg and cefotaxime 1,000 mg every eight hours, starting with the insertion of the PEG tube and maintained for 48 hours. Pain/tenderness, leakage/drainage, bleeding fever, maximum white blood cells (WBC) count, pus/discharge, and PEG tube function were evaluated within 48 hours and 1 week from PEG insertion. Infection at the site of PEG insertion occurred in 3 cases (3.1%) within 48 hours and in 1 case (1.0%) within 7 days. Within 48 hours from the procedure, incidence of fever and increased WBC count was 10.3% and 9.3%, respectively, though at 7 days all were resolved. Pain, leak, and bleeding at the site of PEG placement were prevalently mild within 48 hours (74.2%, 12.4%,13.4% of patients, respectively) and subsided within 7 days (2.1%, 0%, 0%). One case (1.0%) of minor antibiotic side effect occurred. Two patients died due to complications not related to the procedure. The combined use of short-term cefotaxime and clindamycin seems to be effective in reducing incidence of acute complications due to PEG placement without increasing side-effects.Journal of gastrointestinal and liver diseases: JGLD 06/2011; 20(2):131-4. · 1.81 Impact Factor
Novel approach to antibiotic prophylaxis in percutaneous
John Blomberg, PhD student,1,2Pernilla Lagergren, assistant professor,1Lena Martin, postdoctoral scientist,1
Fredrik Mattsson, statistician,1Jesper Lagergren, professor1,3
Objective To evaluate a new and simpler strategy of
antibiotic prophylaxis in percutaneous endoscopic
Design Single centre, two arm, randomised, controlled,
double blind clinical trial.
Setting Endoscopy unit in Karolinska University Hospital,
Stockholm, Sweden, between 3 June 2005 and 31
Participants 234 patients with an indication for PEG who
gave informed consent to participate.
Intervention A single 20 ml dose of the oral solution of
sulfamethoxazole and trimethoprim (also known as
co-trimoxazole or Bactrim; F Hoffmann-La Roche Ltd,
Basel, Switzerland) deposited in the PEG catheter
immediately after insertion. The control group received
standard prophylaxis consisting of a single intravenous
dose of 1.5 g cefuroxime (Zinacef; GlaxoSmithKline,
London) administered before insertion of the PEG tube.
Main outcome measure Primary outcome was the
occurrence of clinically evident wound infection within
14 days after insertion of the PEG catheter. Secondary
outcomes were positive bacterial culture and blood tests
(highly sensitive C reactive protein and white blood cell
count). All randomised patients were included in an
intention to treat analysis.
Results Of the 234 patients included in this study, 116
were randomly assigned to co-trimoxazole and 118 to
cefuroxime. At follow-up 7-14 days after insertion of the
PEG catheter, wound infection was found in 10 (8.6%)
patients in the co-trimoxazole group and 14 (11.9%) in
point difference of −3.3% (95% confidence interval
−10.9% to 4.5%). The per protocol analysis, which
comprised 100 patients in each group, gave similar
results—10% and 13% infection in the co-trimoxazole
and cefuroxime groups, respectively (percentage point
difference −3.0%, 95% CI −11.8% to 5.8%). Both these
analyses indicate non-inferiority of co-trimoxazole
compared with cefuroxime because the upper bounds of
the confidence intervals are lower than the
pre-determined non-inferiority margin of 15%. Analyses
of the secondary outcomes supported this finding.
Conclusion 20 ml of co-trimoxazole solution deposited in
a newly inserted PEG catheter is at least as effective as
preventing wound infections in patients undergoing PEG.
mainly used to maintain enteral nutrition in patients
ductionin 1980,1steadilyincreasedinusetobecome a
common intervention. As a consequence of malnutri-
acute problem after insertion of the PEG catheter.3
of all patients who receive a PEG catheter,4-8and such
infections are often difficult to treat. Meta-analyses of
prophylaxis is given before the PEG procedure.9-12A
single intravenous dose of the cephalosporin cefurox-
ime (Zinacef; GlaxoSmithKline, London), given one
hour before the PEG procedure, is well established as
thegoldstandard methodofantibiotic prophylaxisand
is recommended by the British Society of Gastro-
enterology (evidence grade Ia and recommendation
monly found intheuppergastrointestinal tract.1415Dis-
advantages of this strategy include the high cost, the
need to give the medication intravenously, and the
need to give it before insertion of the PEG catheter,
even though in about 10% of patients insertion of the
catheter proves to be impossible.16
We hypothesised that there is a less expensive, tech-
nically easier, and at least as effective way of infection
prophylaxis than using cefuroxime; that is, depositing
a single dose of a combination of a sulphonamide and
trimethoprim (also known as co-trimoxazole or Bac-
trim; F Hoffmann-La Roche Ltd, Basel, Switzerland),
as an oral solution, directly in the newly inserted PEG
catheter. To test this hypothesis we conducted a large
randomised clinical trial.
Design and intervention
We undertooka double blind, randomised clinical trial
to test whether a single dose of 20 ml co-trimoxazole
1Upper Gastrointestinal Research,
Department of Molecular Medicine
and Surgery, Karolinska Institutet,
SE-171 76 Stockholm, Sweden
2Department of Surgery,
University Hospital, SE-141 86
3King’s College, London
Correspondence to: J Blomberg
Cite this as: BMJ 2010;340:c3115
BMJ | ONLINE FIRST | bmj.compage 1 of 6
(800 mg sulfamethoxazole and 160 mg trimethoprim)
deposited in the PEG catheter immediately after inser-
antibiotic prophylaxis of a single intravenous dose of
tion of the PEG catheter. We chose co-trimoxazole
rather than an oral cephalosporin as the test drug
because of the following advantages: more rapid
absorption in the upper gastrointestinal tract; longer
half life; doesn’t need to be mixed with food intake
(which is difficult immediately after PEG); lower risk
All patients at the Karolinska University Hospital,
Stockholm, Sweden, who were referred to the endo-
scopy unit for PEG during the period 3 June 2005 to
indications for PEG, and were able to give consent to
participation in the study after receiving oral and writ-
ten information were included. Reasons for exclusion
allow the patient to participate, or allergy to any of the
Randomisation and blinding
The randomisation process was conducted by person-
nel at a hospital department not engaged in the care of
ticipate, these personnel were contacted by telephone
pre-prepared block (50 envelopes in each block) of
equally distributed and mixed envelopes, containing
a randomisation sheet with information on the drug
to be used. The patient’s personal identity number
and the date were documented on the randomisation
sheet. Thereafter, the sheet was sent to the study coor-
dinator. The patient and the nurse who evaluated the
patient at the follow-up visit were both blinded to
which antibiotic was to be given. The blinding of the
patients was accomplished by using intravenous fluid
and manipulating the newly inserted PEG catheter in
all patients. This sham manoeuvre was facilitated by
the use of sedation. The nurses who evaluated the
patients at the follow-up visit were not involved in
insertion of the PEG catheter, including the adminis-
tration of antibiotic prophylaxis.
The PEG procedure
All patientsfasted for at least six hoursbeforethe PEG
AstraZeneca, London) was administered as a throat
spray, after which midazolam (Dormicum; Roche)
was given intravenously for sedation. A standard, sili-
con wire reinforced, 20 Charrière Bard FasTrac pull
PEG catheter (Bard Norden AB, Sweden) was used in
all patients. The catheter was pulled down through the
mouth, into the stomach and out through the abdom-
inal wall, and anchored with an external bolster. The
tightness of the bolster position was checked by gently
pulling on the catheter to see if the bolster could easily
be lifted about 5 mm from the abdominal wall, thus
could then be used for infusion within two hours.
Patients were given an information folder that con-
tained a description of what had been done during the
procedure, the brand name of the PEG catheter,
instructions on how to perform daily care of the cathe-
associated with PEG, general nutritional advice, and a
a dietitian for contact whenever advice about the PEG
device or nutrition was needed.
The baseline data collected were name, personal iden-
tity number, age, sex, indication for PEG, comorbid-
ities, and tobacco smoking habits. Peripheral blood
bin, highly sensitive C reactive protein, white blood
cells, and albumin. Objective measurements of weight
and heightwere collected for assessmentof bodymass
At the follow-up appointment within 7-14 days of
sample for bacterial culture was retrieved from the
surement of the same parameters as presented above.
If the patient was unable to attend the follow-up visit,
the patient or caring personnel were contacted by tele-
phone and interviewed by the study nurse, who asked
whether any complications had occurred. If this inter-
was given a new urgent appointment and was checked
up at the outpatient clinic, where any infectious com-
plications were documented.
Finally, information on any deaths was obtained by
checking the complete and continuously updated
Swedish Total Population Register.
The primary outcome was occurrence of a clinically
identifiable wound infection, as judged by a red zone
around the catheter or occurrence of pus, subcuta-
neous swelling, and pain on palpation in the area
around the catheter. Secondary outcomes were objec-
tive signs of infection, including a positive bacterial
culture, high levels of highly sensitive C reactive pro-
tein, and a high white blood cell count.
ference between the co-trimoxazole and the cefurox-
ime group in the proportion of patients with an
infection was estimated, as was the corresponding
two sided 95% confidence interval (CI). Non-inferior-
ity of co-trimoxazole would be achieved if the upper
page 2 of 6
BMJ | ONLINE FIRST | bmj.com
limit of the 95% CI was smaller than the pre-specified
non-inferiority margin of 15%. The non-inferiority
margin was selected on a clinical basis.
Assuming infection rates of 15% or 20% in both
groups, the number of patients required to establish
non-inferiority with 80% power and significance level
of 5% were 89 or 112, respectively. Differences
between the two treatment groups were tested with
the t test or the Mann-Whitney U test for continuous
variables, depending on which assumption was met.
The χ2test was used for categorical variables as long
as the expected count in every cell was at least five,
otherwise Fisher’s test of exact probability was used.
Intention to treat was the main analysis strategy and
encompassed all randomised patients irrespective of
whether they received a PEG catheter or not, or were
followed up or not. A per protocol analysis was con-
ducted as a sensitivity test, and included only those
patients who underwent PEG and were followed up.
The software SAS Statistical Package (Version 9.2;
SAS Institute Inc, Cary, NC) was usedfor all statistical
Inclusion of patients
The figure presents a flow chart of patients considered
for the study. During the four year study period, 535
sion. Of these patients, 301 were unable to give
informed consent or did not wish to participate in the
study. The remaining 234 patients were randomly
assigned to a study arm and included in the intention
to treat analysis: 116 patients in the co-trimoxazole
group and 118 patients in the cefuroxime group. A
PEG for anatomical reasons. Between the PEG proce-
dure and the follow-up visit, five patients died, one
patient pulled out the PEG catheter without ensuing
complications, three patients were lost to follow-up,
and one patient who was randomised to cefuroxime
received co-trimoxazole instead. After exclusion of
these 34 patients, 100 patients in each group remained
for the per protocol analysis.
sented in table 1. No substantial differences existed
between the two groups regarding age, mortality at
30 days, tobacco smoking status, or occurrence of dia-
betes, but the proportion of men in the cefuroxime
group was non-significantly higher. The indications for
PEG were also evenly distributed, except for a higher
proportion of patients with oesophageal cancer in the
was the most common reason for PEG in both groups.
Table 2 summarises the occurrence of pre-defined
complications in the two treatment groups after inser-
tion of the PEG catheters. One or more of these com-
the co-trimoxazole group and in 47% (55/118) of the
patients in the cefuroxime group (P=0.590). None of
the individual complications was strongly over-repre-
sented in any of the groups, but the frequencies of
catheter leakage, constipation, abdominal pain, fever,
and infection were non-significantly higher in the
cefuroxime group (table 2).
No adverse reactions to the antibiotics used were
recorded among the included patients.
Wound infection (primary outcome)
cally identifiable wound infection was 8.6% (10/116) in
the co-trimoxazole group and 11.9% (14/118) in the
cefuroxime group. The percentage point difference
between the rate of infection in the co-trimoxazole
Randomised to co-trimoxazole (n=116)Randomised to cefuroxime (n=118)
Patients with indications for PEG (n=535)
Patients randomised (n=234)
PEG not possible (n=12)
Died before follow-up (n=3)
Lost to follow-up (n=1)
PEG not possible (n=12)
Died before follow-up (n=2)
Pulled out the PEG catheter (n=1)
Lost to follow-up (n=2)
Randomised to cefuroxime but received
Did not give informed consent or declined to participate (n=301)
Intention to treat
PEG patients randomised to
co-trimoxazole and followed up (n=100)
PEG patients randomised to
cefuroxime and followed up (n=100)
Per protocol analysis
Flowchart of patients considered for the trial of antibiotic prophylaxis in patients with a need
for percutaneous endoscopic gastrostomy (PEG)
Table 1 |Characteristics and indications for percutaneous
endoscopic gastrostomy (PEG) for the 234 patients
randomised to Bactrim or Zinacef
Female 42 (36)31 (26)
Age (mean in years (±standard
66 (12)65 (12)
30 day mortality8 (7) 5 (4)
Current tobacco smoker32 (28) 41 (35)
Diabetes 8 (7)8 (7)
Indication for PEG
Ear, nose, or throat cancer58 (50)69 (59)
Neurological disease24 (21)18 (15)
Oesophageal cancer20 (17) 10 (9)
Stroke4 (4)7 (7)
Dementia1 (1)0 (0)
Gastric cancer0 (0)1 (1)
Other9 (8)13 (11)
All values are number (%) unless stated otherwise and rounded up,
which in some cases gives a sum of more than 100%.
BMJ | ONLINE FIRST | bmj.compage 3 of 6
(percentage point difference −3.0%, 95% CI −11.8% to
5.8%). Both these analyses indicated non-inferiority of
co-trimoxazolecompared withcefuroxime because the
the pre-determined non-inferiority margin of 15%.
Positive bacterial culture or blood chemistry (secondary
patients in the co-trimoxazole group and in 71% (84/
118) in the cefuroxime group. A positive bacterial cul-
ture was identified in 44 out of 81 patients (54%) in the
co-trimoxazole group and in 53 out of 84 patients
(63%) in the cefuroxime group (P=0.252; table 3). Of
cally identifiable wound infection, eight had a positive
bacterial culture, whereas the corresponding propor-
tion in thecefuroxime groupwas 11 out of 14 patients.
with an infection was Staphylococcus aureus.
The comparison groups showed no differences
regarding changes in blood chemistry between base-
line and follow-up (table 4).
This single centre, two arm, randomised, controlled,
double blind clinical trial indicates that infection pro-
phylaxis with 20 ml co-trimoxazole, deposited in the
PEG catheter immediately after its insertion, prevents
wound infection at least as effectively as pre-operative
intravenous cefuroxime in patients undergoing PEG.
Antibiotic prophylaxis is usually accomplished by
using a second generation cephalosporin, such as
cefuroxime, given as a single intravenous dose just
before the PEG procedure. However, this strategy
has several drawbacks. Firstly, PEG is a common pro-
cedure, and the cost of intravenous antibiotic drugs is
not negligible. Secondly, giving an antibiotic intra-
venously is a time consuming process that requires
special equipment. Thirdly, achieving the one hour
and the insertion of the PEG catheter requires good
it proves impossible to insert a PEG catheter, the pro-
phylaxis is given in vain.16Fifthly, there is a risk of
superimposed infection with Clostridium difficile after
a single dose of a cephalosporin given as antibiotic
Assuming that the results of the present study are
true—that is, that co-trimoxazole solution given in the
intravenous cephalosporin—these five problems are
solved. This new strategy is inexpensive, requires no
intravenous administration,andis given after thePEG
tially have a localantibacterial effect with rapid perito-
The efficacy of antibiotic prophylaxis in surgery has
been shown to be reduced if it is administered more
than one hour after incision,21but the PEG procedure
found effect on the efficacy of co-trimoxazole prophy-
laxis. Co-trimoxazole, an inexpensive sulphonamide
tion hasgood bioavailability anda long half life(about
10 hours for both components), and has an anti-
bacterial spectrum suitable for the flora common in
the upper gastrointestinal tract, including meticillin
resistant S aureus (MRSA).2324
Comparison with other studies
procedure, it is associated with a general complications
rate reported to be as high as 50% and a major compli-
cations rate of up to 7.4%.1625Wound infection is the
most common problem, with a frequency of up to
often requiretreatment withsystemicantibiotics, inten-
ter if fitted too tightly. These wound infections can also
develop into a more devastating kind—for example,
necrotising fasciitis—with high mortality.27Infectious
complications entail patient discomfort and costs; for
example, owing to a longer hospital stay.28
prophylaxis in PEG procedures decreases the infection
rate, with an absolute risk reduction of 14-17% and a
Table 2 |Complications after insertion of the percutaneous
endoscopic gastrostomy (PEG) catheter
No complications 66 (57)63 (53)
Abdominal pain 13 (11)17 (14)
Leakage around the catheter 10 (9)16 (14)
Infection10 (9)14 (12)
PEG procedure failed12 (10) 12 (10)
Constipation 7 (6)11 (9)
Diarrhoea5 (4)4 (3)
Patient died before follow-up 3 (3)2 (2)
Fever0 (0) 3 (3)
Patient pulled out PEG catheter
0 (0)1 (1)
Values are number (%). Each individual patient could have more than
Table 3 |Bacterial growth in culture of samples retrieved from
the percutaneous endoscopic gastrostomy (PEG) stoma at
7-14 days after insertion of the PEG catheter
Positive growth 44 (38) 53 (45)
Negative growth37 (32)31 (26)
No culture performed 35 (30)34 (29)
Values are number (%).
page 4 of 6
BMJ | ONLINE FIRST | bmj.com
number needed to treat to avoid one infection of
between six and 10.11122930To reduce infections and
prophylaxis during PEG is recommended. Our novel
approach of giving an oral antibiotic solution directly
into the PEG catheter immediately after insertion has
not to our knowledge been tested previously.
Strengths and limitations of the study
Advantages of this study include the prospective ran-
tors, and the complementary use of objective markers
of infections—that is, bacterial cultures and blood
chemistry. Among the disadvantages, the included
patients had to be well enough to be able to give
informed consent, and, therefore, they might have
been healthier than those who were not included. On
the other hand, the patients with ear, nose, or throat
cancer, who made up the majority of patients in both
study groups, were likely to have received chemora-
on their immunological defences.
The potential for problems with the subjectivity of
infection diagnosis was counteracted by the strict
blinding of patients and the experienced nurses who
evaluated the patients at follow-up. Moreover, the sec-
ondary outcomes were objective and the results of the
Conclusions and policy implications
In conclusion, this prospective clinical trial of patients
who require PEG—which had a strict randomisation
process and blinding of all patients and evaluators,
and used several outcome markers—indicates that
antibiotic prophylaxis with 20 ml co-trimoxazole
administered through a newly inserted PEG catheter
prevents infectious complications at least as well as
the standard prophylaxis with intravenous 1.5 g cefur-
oxime given before the PEG procedure.
We express our gratitude to Margrete Gellervik for excellent
administrative help, to the nurses who cared for the patients with PEG
cathetersand managedalldocumentation,and thestaffattheendoscopy
Contributors:JL, PL, and LM formulated the study hypothesis. JB and JL
recruited the patients and performed the percutaneous endoscopic
gastrostomy procedures, and, together with PL and LM, met the patients
at the initial visit. FM, JB, and JL did the statistical analyses. JB wrote the
stages and critically reviewed and contributed to the final draft.
Funding:This study was funded by the Swedish Cancer Society and
Swedish Research Council.
Competinginterests:All authors have completed the Unified Competing
Interest form at www.icmje.org/coi_disclosure.pdf (available on request
from the corresponding author) and all authors declare: (1) No financial
support for the submitted work from anyone other than their employer;
(2) No financial relationships with commercial entities that might have an
interest in the submitted work; (3) No spouses, partners, or children with
relationships with commercial entities that might have an interest in the
submittedwork; (4)No non-financialinterests that maybe relevant to the
Ethicalapproval:The regional ethics committee in Stockholm, Sweden,
approved this study (registration number 05/505-31).
Datasharing:No additional data available.
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laparotomy: a percutaneous endoscopic technique. J PediatrSurg
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Table 4 |Blood chemistry at baseline and at follow-up 7-14 days after insertion of the percutaneous endoscopic gastrostomy
Co-trimoxazole (n=116)Cefuroxime (n=118)
Baseline Follow-up Baseline Follow-up
C reactive protein (mg/l)7.3 (3.3, 30.7)8.7 (4.5, 32.4) 6.9 (2.3, 21.4)7.4 (3.9, 30.0)
White blood cell count (×109/l) 7.3 (5.7, 11.2)7.2 (5.7, 9.4)7.8 (5.9, 10.2)7.2 (5.4, 9.3)
Haemoglobin (g/l)125 (18) 121 (15)124 (17) 125 (16)
Albumin (g/l) 32 (27, 36)32 (27, 35)33 (28, 36) 33 (29, 36)
Values are median (lower and upper quartile) for C reactive protein, white blood cell count, and albumin. Values are mean (±standard deviation) for
WHAT IS ALREADY KNOWN ON THIS TOPIC
Wound infection is a common complication of percutaneous endoscopic gastrostomy (PEG)
Several randomised studies and meta-analyses have shown a positive effect of antibiotic
prophylaxis on the risk of infection after insertion of a PEG catheter
Antibiotic prophylaxis usually comprises a single intravenous dose of a second generation
cephalosporin administered just before the PEG procedure, which is rather expensive, time
consuming, and can begiven in vain in patients in whom the PEG procedure is impossible to
WHAT THIS STUDY ADDS
Administering the oral solution of co-trimoxazole, a combination of a sulphonamide and
trimethoprim (Bactrim), in the PEG catheter immediately after insertion is as effective at
preventing wound infections as the standard prophylaxis regimen of cefuroxime (Zinacef)
given intravenously before the PEG procedure
This new strategy of antibiotic prophylaxis with co-trimoxazole can be administered rapidly
and is inexpensive, safe, less likely to be administered needlessly, and could be used
wherever in the world the PEG procedure is done
BMJ | ONLINE FIRST | bmj.compage 5 of 6
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Accepted: 22 April 2010
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