Antibiotikaprofylax vid kirurgiska ingrepp - SBU

Table 4.1.4 continued
Author
Year
Reference
Country
Study
design
Population
characteristics
Intervention
Method
Number individuals
Control
Number
indiviuduals
Results
Withdrawal
Drop outs
Study quality
and relevance
Comments
Higgins
1999
[34]
United
Kingdom
RCT
412 pts elective laparoscopic
cholecystectomy
Power analysis. Blinded.
Follow-up 30 days.
Defined SSI
I1: Cefotetan 1 g iv (n=137)
within 60 min before
operation
I2: Cefazolin 1 g iv (n=140)
C: Placebo 50 mL
NaCl (n=135)
Infection rate
I1: 3 superficial
infections 2.2%
I2: 2 superficial and
2 distant infections
2.9%
C: 2 superficial
infections and
1 distant infection
– 2.2% overall
infection rate
38 pts
Protocol
violation
I1: 13,
I2: 11,
C: 14
High
Cefotetan 3 times more
expensive. Power analysis
after study. Shows 5 444
pts would be needed
to show a difference.
Selected group with no
acute cholecystitis, choledochoithiasis
or acute
pancreatitis
Illig
1997
[35]
USA
RCT
Elective laparoscopic
cholecystectomy. Power
calculation. Defined SSI.
Low-risk pts: no acute
cholecystitis jaundice,
DM, immunosuppression
foreign body. Follow-up
30 days
I: Cefazolin 1 g 30 min before
operation, 8 and 16 h after
(n=128)
C: Placebo
(n=122)
Major infection
I: 0%
C: 1 pt (0.8%)
Minor infection
I: 1 pt (0.8%)
C: 3 pts (2.5%)
34 pts got
more ab
than in
protocol
Moderate
Risk factors: old age –
not strong association.
Low number of patients.
Administration of ab did
not influence bacteria in
bile
Koc
2003
[38]
Turkey
RCT
112 pts with elective LC.
Low-risk pts – no biliary
obstruction, cholecystitis.
Post-op infection defined.
30 days follow-up. Teams
and pts blinded. Multivariate
analysis
I: Cefotaxime 2 g before
operation and 24 h after
C: Saline Infection
I: 1/49 (2.04%)
C: 1/43 (2.32%)
20 pts
Protocol
violation
Moderate
No indication of ab in
LC. Multivariate analysis
for risk factors, diabetes
mellitus, cholecystitis.
No spillage of infected
bile
Kuthe
2006
[11]
India
RCT
93 pts with elective LC.
Randomisation – random
number. 4 weeks followup.
Blinded surgical team.
SSI
I: Cefuroxime 1.5 g iv at
induction of anesthesia
(n=40)
C: Saline (n=53) Wound infection
I: 1 pt (2.5%)
C: 2 pts (3.7%)
11 pts
(Spillage,
conversion)
Moderate
Age, weight, duration,
positive bile culture no
risk. Diabetes, cholecystitis
risk factors
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