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Antibiotikaprofylax vid kirurgiska ingrepp - SBU

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Table 4.2.2 continued<br />

Author<br />

Year<br />

Reference<br />

Country<br />

Study<br />

design<br />

Population<br />

characteristics<br />

Intervention<br />

Method<br />

Number indi<strong>vid</strong>uals<br />

Control<br />

Number<br />

indi<strong>vid</strong>uals<br />

Results<br />

Withdrawal<br />

Drop outs<br />

Study quality<br />

and relevance<br />

Comments<br />

Itani<br />

2006<br />

[18]<br />

USA<br />

RCT<br />

Pts undergoing elective<br />

colorectal surgery.<br />

901 mITT (451/450)<br />

and 672 (338/334) per<br />

protocol.<br />

Female/male: 52.7%/56.2%.<br />

Age mean: 61.3 and<br />

60.2 years.<br />

n=1 002<br />

Follow-up 4 weeks<br />

I: Ertapenem 1 g 60 min<br />

prior to the operation<br />

(n=338)<br />

C: Cefotetan 2 g<br />

60 min prior to<br />

the operation<br />

(n=334)<br />

SSI (superficial or deep<br />

or organ-space infection)<br />

Per protocol<br />

I: 18.1%<br />

C: 31.1%<br />

Absolute difference –13.0%<br />

(95% CI –19.5 to –6.5)<br />

Any failure<br />

I: 28%<br />

C: 42.8%<br />

Absolute difference –14.8%<br />

(95% CI –21.9 to –7.5)<br />

70 excluded<br />

from randomisation.<br />

No<br />

ITT was performed<br />

Moderate<br />

Very high number<br />

of failures in both<br />

groups. In metaanalysis<br />

[1]<br />

Unexplained use of antibiotics<br />

I: 6.9%<br />

C: 7.5% ns<br />

Anastomotic leakage<br />

I: 3%<br />

C: 4.2% ns<br />

Distant site infections<br />

I: 6 %<br />

C: 6% ns<br />

Ivarsson<br />

1982<br />

[24]<br />

Sweden<br />

RCT<br />

Pts undergoing elective<br />

colorectal surgery.<br />

n=140<br />

I: Cefoxitin 2 g 1–15 h<br />

before operation and 2<br />

more doses after 6 h and<br />

12 h (n=55)<br />

C: Doxycycline<br />

200 mg before and<br />

after 12 h (n=47)<br />

Infectious complications<br />

I: 18%<br />

C: 13%<br />

38 reason<br />

given<br />

Moderate<br />

In meta-analysis<br />

[1]<br />

The table continues on the next page<br />

166 antibiotikaprofylax <strong>vid</strong> <strong>kirurgiska</strong> <strong>ingrepp</strong> KAPITEL 4 • den systematiska litteraturöversikten<br />

167

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