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Antibiotikaprofylax vid kirurgiska ingrepp - SBU

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Table 4.5.7 continued<br />

Author<br />

Year<br />

Reference<br />

Country<br />

Study design<br />

Population<br />

characteristics<br />

Intervention/<br />

Method (I)<br />

Control Results Withdrawal<br />

Drop outs<br />

Study quality<br />

and relevance<br />

Comments<br />

Evrard<br />

1985, 1988<br />

[52,53]<br />

France<br />

RCT, double<br />

blind, multicenter.<br />

Power calculation<br />

for surrogate<br />

endpoint<br />

THR<br />

No ab cement, regular<br />

operating room<br />

Excluded: Re-op,<br />

infected, malignancy.<br />

Follow-up 1 year<br />

I: Cefamandole 1.5 g at<br />

induction of aneshesia<br />

followed by 0.75 g<br />

x 4 x II followed by<br />

placebo (n=488)<br />

C: Cefazolin 1 g<br />

at induction of<br />

aneshesia and<br />

then x 4 x V<br />

(n=477)<br />

Positive cultures<br />

in drains<br />

I: 44/488 (9.2%)<br />

C: 35/477 (7.5%) ns<br />

Deep wound infection<br />

I: 5/488 (2.5%)<br />

C: 3/477 (1.7%) ns<br />

18 protocol<br />

violations in<br />

each group<br />

Death 16,<br />

8.6% lost to<br />

follow-up<br />

Moderate<br />

Frajman<br />

1991<br />

[27]<br />

France<br />

RCT, open THR or TKR C: Cefotiam 2 g at<br />

induction of anesthesia<br />

with option of another<br />

if operation >4 h<br />

(n=89)<br />

C: Cefazolin 1 g<br />

at induction of<br />

anesthesia, then<br />

1 g x 4 x II<br />

(n=118)<br />

Wound infection<br />

I: 0/89<br />

C: 0/118<br />

ns<br />

Not reported<br />

Moderate<br />

No power calculation.<br />

No events in<br />

either group<br />

Mauerhan<br />

1994<br />

[55]<br />

USA<br />

RCT, double blind,<br />

mulitcenter<br />

THR or TKR including<br />

revision operation<br />

Excluded: Renal failure,<br />

neutropenia, recent ab<br />

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