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Antibiotikaprofylax vid kirurgiska ingrepp - SBU

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Table 4.1.5 Open cholecystectomy.<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 />

Aloj<br />

1991<br />

[66]<br />

United<br />

Kingdom<br />

and Italy<br />

RCT<br />

Compare to ab. SSI defined.<br />

103 pts with OC. Risk<br />

factors evaluated (>60,<br />

jaundice, cholangitis, CBD<br />

stones, previous biliary<br />

surgery). Bile cultures<br />

I1: Piperacillin 2 g im<br />

before surgery and 12 h<br />

interval for 48 h (n=56).<br />

I2: Tobramycin 100 mg<br />

im at same intervals<br />

(n=47)<br />

SSI<br />

I1: 7 (12.5%)<br />

I2: 11 (23.4%)<br />

Not stated<br />

Moderate<br />

Dervisoglou<br />

2006<br />

[23]<br />

Greece<br />

RCT<br />

Compare ampicillin/subactam<br />

with coverage of<br />

Enterococcus sp vs cephalosporin<br />

1 center. OC<br />

(n=288) or laparoscopic<br />

cholecystectomy:<br />

(n=190). Computer<br />

randomisation. Infection<br />

defined. Power calculation.<br />

549 evaluated, 418 pts<br />

eligible. Follow-up 4 weeks<br />

I1: Ampicillin-sulbactam<br />

3 g iv at induction of<br />

anesthesia (n=211)<br />

I2: Cefuroxime 1.5 g at<br />

same schedule (n=207)<br />

Wound infection<br />

I1: OC 1/211<br />

Lap group: 0/93<br />

I2: OC 18/207<br />

Lap group: 5/97<br />

44 emergency<br />

operations,<br />

37 acute<br />

cholecystitis,<br />

26 other<br />

simultaneous<br />

operations,<br />

19 allergy,<br />

other diseases<br />

High<br />

Enterococcus common<br />

in infected pts. Fewer<br />

diabetic pts in I1 had<br />

infection than I2 (equal<br />

number of DM). OC<br />

was more commonly<br />

performed in high-risk<br />

pts<br />

Fabian<br />

1988<br />

[25]<br />

USA<br />

RCT<br />

Multicenter (5) 10 per trial<br />

of two cephalosporins in<br />

elective biliary surgery<br />

(mostly OC). Computer<br />

randomisation.<br />

n=260<br />

I1: Cefotetan 2 g iv<br />

30 min prior to operation<br />

+ 6 h intervals for 24 h<br />

I2: Cefoxitin 2 g at same<br />

schedule. In later phase<br />

1 g cefotetan dose was<br />

used<br />

Wound infection<br />

I1: 2/155<br />

I2: 2/68<br />

37 pts (14%)<br />

protocol<br />

violation<br />

Moderate<br />

No differences. Authors<br />

recommend cefotetan<br />

Garcia-<br />

Rodriguez<br />

1989<br />

[26]<br />

Spain<br />

RCT<br />

1 451 pts with biliary<br />

surgery and gastric resection<br />

among others.<br />

Complications not separated.<br />

Only gallbladder<br />

and bile duct surgery<br />

I1: Cefotaxime 1 g before<br />

operation (n=512).<br />

I2: Cefoxitin 2 g in 4 doses,<br />

one before, 6, 12 and 18 h<br />

post-op (n=514)<br />

Wound infection<br />

I1: 3.3%<br />

I2: 7.5%. Statistically<br />

significant<br />

7 pts in total.<br />

No info on<br />

post-op<br />

Moderate<br />

Large material. Groups<br />

not separated. Majority<br />

OC. Cefotaxime most<br />

effective<br />

Gazzaniga<br />

1992<br />

[16]<br />

Italy<br />

RCT<br />

Ultra short prophylaxis<br />

vs short prophylaxis.<br />

44 centres (each centre<br />

at least 10 pts). Power<br />

calcuation. Follow-up<br />

1 week. Defined SSI<br />

I: Ceftazidine 2 g iv at<br />

anesthesia induction<br />

(n=386)<br />

C: Ceftazidine<br />

1 g iv 30 min<br />

before operation<br />

+ 6 and 12 h<br />

after first dose<br />

(n=382)<br />

Wound infection<br />

I1: 2.9%<br />

C: 3.7%<br />

Sepsis<br />

I: 0.3%<br />

C: 0.3%<br />

12 pts in I and<br />

3 in C because<br />

protocol<br />

violation<br />

Moderate<br />

Large study. Low<br />

infection rate. Ultra<br />

short regimen preferred.<br />

Sponsored<br />

by Glaxo<br />

The table continues on the next page<br />

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

109

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