Comparison of single-dose cefotetan and multidose cefoxitin as intravenous prophylaxis in elective, open biliary tract surgery: a multicentre, double-blind, randomized study.
OBJECTIVE
To compare the safety, tolerance and prophylactic effectiveness of a single 2-g dose of cefotetan with a standard prophylactic regimen of cefoxitin in reducing the incidence of postoperative infections after elective, open biliary tract surgery.


METHODS
Multicentre, double-blind, randomized comparative study with a 4-week follow-up.


METHODS
Five Canadian university centres.


METHODS
One hundred and eleven patients scheduled to undergo elective, open biliary tract surgery.


METHODS
The patients were randomly assigned to receive either cefotetan or cefoxitin in a ratio of 2:1; 76 patients received cefotetan and 35 received cefoxitin.


METHODS
Wound infection as defined by the Centers for Disease Control and Prevention and by clinical evaluation, adverse events and laboratory parameters.


RESULTS
Two incisional wound infections were reported by patients in the cefotetan group, for an overall infection rate of 1.8% (2 of 111). No significant differences were found in the failure rate or in any other indicator of efficacy. The incidence of adverse events for cefotetan (12.6%) was not statistically different from that for cefoxitin (10.4%), and none of the 16 adverse events in the cefotetan group and 5 in the cefoxitin group was serious or severe. Only one event (rash) was possibly related to the study drugs. Several hematologic and biochemical parameters were found to be normal preoperatively and abnormal postoperatively, but no relation was found between these variations and the study drugs. These changes were mainly attributable to the operation.


CONCLUSIONS
Cefotetan was found to be effective and comparable to cefoxitin, both in safety and in reducing the incidence of infection after elective, open biliary tract surgery.
Lapointe
R W
RW
St-Luc Hospital, Montreal, Que.
Roy
A F
AF
Turgeon
P L
PL
Lewis
R T
RT
Dagenais
M H
MH
Joly
J R
JR
Scudamore
C H
CH
Roy
P D
PD
Conly
J M
JM
Syrotuik
J
J
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001662:Biliary Tract Surgical Procedures; D015313:Cefotetan / Q000008:administration & dosage* / Q000009:adverse effects; D002440:Cefoxitin / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D013530:Surgical Wound Infection / Q000382:microbiology / Q000517:prevention & control*
D015313:Cefotetan; D002440:Cefoxitin