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
Jewesson
1997
[19]
Canada
RCT
Pts undergoing elective
colorectal surgery were
included. Prospective,
randomised doubleblinded
study.
n=153
Follow-up by telephone
at day 30
I1: Ceftizoxime 1 g,
Female/male: 16/22,
Mean age: 64 years
(n=38)
I2: Metronidazole 50 mg
+ gentamicin 120 mg,
Female/male: 25/20,
Mean age: 64 years
(n=45)
I3: Cefoxitin 1 g at 0, 12
and 24 h,
Female/male: 17/22,
Mean age: 58 years,
”High-risk” pts could
receive another 8 doses
(n=39)
No infection
I1: 100%
I2: 85%
I3: 74% p=0.005
Mean ASEPSIS scores were
higher for I2 and I3 vs I1.
No wound infection requiring
systemic antibiotics
I1: 100%
I2: 84%
I3: 74%
p=0.04
LOS
I3 longer hospital stay
vs I1 p=0.04
31 pts were
excluded
High
A sample of
50 pts in each
arm was estimated
to be needed
to detect a reduction
of 15%
in clinical success
rate at a significant
level of 5%
and a power of
90%
Kobayashi
2007
[22]
Japan
RCT
Pts undergoing elective
surgery for colorectal
cancer were randomised.
7 pat were lost to
follow-up
Intervention:
Female/male: 105/137.
Mean age: 69 years
Control:
Female/male: 88/154.
Mean age 67 years
n=491
I: Cefametazole 1 g before
operation and than twice
daily for 3 days (n=242)
C: Cefametazole
1 g before operation
and than twice
daily for 3 days
+ 1 g kanamycin
and 400 mg erythromycin
at
14.00, 15.00 and
23.00 h the day
before operation
(n=242)
SSI
I: 10.7%
C: 7% (95% CI –4.8 to 5.6)
Incisional SSI
I: 5.8%
C: 2.5%
Organ SSI
I: 4.9%
C: 4.5%
Adverse events
I: 9 pts
C: 12 pts
High
SSI according to
CDC guidelines
Follow-up 6 weeks
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