Antibiotikaprofylax vid kirurgiska ingrepp - SBU

Table 4.2.2 continued
Author
Year
Reference
Country
Study
design
Population
characteristics
Intervention
Method
Number individuals
Control
Number
individuals
Results
Withdrawal
Drop outs
Study quality
and relevance
Comments
Woodfield
2003
[15]
New Zealand
RCT
Pts undergoing acute or
elective open abdominal
surgery.
Female/male: 250/212 (I),
232/226.
Mean age 51.6 years (I),
49.6 years (C).
n=1 013
Follow-up 4 weeks
I: Ceftriaxone 1 g + metronidazole
500 mg. Appendectomy
did not receive
metronidazole (n=462)
C: Cefotaxime 1 g
+ metronidazole
500 mg. Appendectomy
did not
receive metronidazole
(n=458)
Wound infection
with pus or cellulitis
I: 31/3 798 (8,2%)
C: 36/358 (10.1%) ns
(appendectomy withdrawn)
Anastamotic morbidity
I: 3%
C: 8%. p=0.054
Mostly
therapeutic
antibiotics
High
Cefotaxime
without metronidazole
did not
work on pts with
appendectomy
(in contrast to
ceftriaxone)
Chest infection and/or UTI
I: 6%
C: 11%, p=0.01
Zanella
2000
[16]
Italy
RCT
Pts undergoing elective
colorectal surgery.
Female/male: 46%/54%.
Age: 19–92 years,
median 66 years.
77.7% had neoplastic
disease. All had mechanical
bowel preparation.
n=615
Folllow-up 4–6 weeks
I: Cefepime 2 g + metronidazole
500 mg. An extra
dose was given if surgery
exceeded 12 h (n=307)
C: Ceftriaxone 2 g
+ metronidazole
500 mg (n=308)
Primary site infection
prevented
I: 92.8%
C: 92.9%
Clinical success
I: 75.2%
C: 75.3% (95% CI –7.5
to 7.3%)
1 pt High
Very well performed
study.
In meta-analysis
[1]
Zelenitsky
2000
[10]
Canada
RCT
Pts undergoing colorectal
elective surgery.
Female/male: 45.9%/
54.1% (I), 43.1%/56.9% (C).
Mean age: 56.7 years (I),
57.8 years (C).
n=164
Follow-up 30 days
I: Gentamicin 4.5 mg/kg
+ 500 mg metronidazole
pre-op. and placebo at
8, 16, 24 h
C: Gentamicin
1.5 mg/kg +
500 mg metronidazole
pre-op
and 8, 16, 24 h
(n=72)
Superficial SSI
I: 18.9%
C: 30.6%
(95% CI 20–41.2) p=0.05
Deep SSI
I: 8.1%
C: 6.9%
(95% CI 0.3–3.7) p=0.94
Distant infections
I: 4 pts
C: 3 pts
18 pts were
excluded
Moderate
Significant higher
concentrations
of gentamicin in
serum at the time
of closure in the
single-dose group.
Per protocol
analysis. In metaanalysis
[1]
ASEPSIS score = Measures erythema, exudates and wound separation; C = Control
group; CDC guidelines = Centers for Disease Control and Prevention; CI = Confidence
interval; h = Hour; I = Intervention group; ITT = Intention-to-treat; iv = intravenous; LOS
= Length of hospital stay; LRTI = Lower respiratory tract infections; mITT = Modified
intention-to-treat; MRSA = Meticillinresistent Staphylococcus aureus; n = Number of
patients; ns = Non significant; OR = Odds ratio; RCT = Randomised controlled trial;
RR = Relative risk; SSI = Surgical site infection; UTI = Urinary tract infection
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