Antibiotikaprofylax vid kirurgiska ingrepp - SBU

Table 4.5.3 continued
Author
Year
Reference
Country
Study design
Population
characteristics
Intervention/
Method (I)
Control (C) Results Withdrawal
Drop outs
Study quality
and relevance
Comments
Gatell
1987
[9]
Spain
RCT double-blind,
open
Closed fractures
operated with metal
devices. Excluded:
Total hip replacement,
ongoing ab
I: Cefamandole
1 dose
2 g 30 min
pre-op, 2, 8,
followed by 4
placebo doses
(n=382)
C: Cefamandole
5 doses: 2 g 30 min
pre-op and 2 h postop,
1 g 8, 14, 20 h
post-op
(n=335)
Deep wound infection
followed until healed
I: 9/382 (2.4%)
C: 1/335 (0.3%)
p=0.043
33/750
“protocol,
violation”
High
Included in
Cochrane review
[5], statistical
recalculated
Gillespie
2001
[5]
Cochrane review,
meta-analysis/
systematic review
of antibiotic prophylaxis
in closed
long bone fractures
Closed fractures of hip or
other long bones undergoing
surgery for fixation
or replacement. 2 RCT
comparing one dose vs
multiple doses (Gatell 1987
[9], Buckley 1990 [10])
I: Systemic
antibiotics,
one dose
(n=465)
C: Systemic antibiotics,
multiple
doses of the same
antibiotic
(n=456)
Deep wound infection
Multiple doses
marginally more
effective RR 7.89
(95% CI 1.01–61.97)
Moderate
Meta-analysis of
two studies, one
of which without
events
Gillespie
2001
[5]
Cochrane review,
meta-analysis/
systematic review
of antibiotic prophylaxis
in closed
long bone fractures
Closed fractures of hip
or other long bone undergoing
surgery for fixation
or replacement. 2 RCT
comparing 24 h vs longer
antibiotic duration
(Hedström 1987 [15]
and Nelson 1983 [16])
I: Systemic
antibiotics,
multiple
doses for
24 h
(n=124)
C: Systemic antibiotics
>24 h
duration of the
same antibiotics
(n=100)
Deep wound infection
No difference
RR 1.10 (95%
CI 0.22–5.34)
Moderate
Meta-analysis of
two studies, one
of which with only
one event
Hedström
1987
[15]
Sweden
RCT, double blind
2 centers
Trochanteric fracture
op with nail and plate.
Excluded: Op >2 days
after fracture unable
to tolerate oral ab.
Follow-up 6 weeks–4 months
I: Cefuroxime
first dose
1–2 h pre-op
0.75 g x 3
x 1 followed
by placebo
x 2 x 6 days
(n=65)
C: Cefuroxime first
dose 1–2 h pre-op
0.75 g x 3 x 1 followed
by po cefalexin 0.5 g x
2 x 6 days
(n=56)
Deep wound infection
I: 1/65 (1.5%)
C: 0/56 (0%)
ns
Superficial wound
infection
I: 4/65 (6.2%)
C: 6/56 (10.7%)
ns
26/147 for
protocol
violations and
withdrawel
Moderate
Included in
Cochrane
review [5]
No power
calculation
Nelson
1983
[16]
USA
CT, open, randomised
by last digit
of hospital record
Hip fracture repair
Follow-up 12 months
I: Nafcillin first
dose 20 min
pre-op (or if
allergy cefazolin)
0.5 g x
4 x I
(n=59)
C: Nafcillin first dose
20 min pre-op (or if
allergy cefazolin) 0.5 g
x 4 x III followed by po
0.5 g x 4 x IV
(n=44)
Deep wound
infection
I: 2/59 (3.4%)
C: 2/44 (4.5%)
Not stated
Moderate
Included in
Cochrane review
[5]. Inadequate
randomisation procedure
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