The Journal of Bone and Joint Surgery, Vol 66, Issue 8 1219-1222, Copyright © 1984 by Journal of Bone and Joint Surgery, Inc
Prophylactic cefamandole in orthopaedic surgery
JM Gatell, J Riba, ML Lozano, J Mana, R Ramon and J Garcia SanMiguel
Three hundred patients were included in a prospective randomized
double-blind trial comparing the efficacy of cefamandole with that of a
placebo for prophylaxis of sepsis in operations using Ender or Kuntscher
nails, bone plates, or other internal fixation devices. Patients with an
open fracture, total joint replacement, or direct operation on the hip were
not included in the study. Sixteen patients were excluded because the trial
protocol was not followed exactly, so a total of 284 patients participated,
134 of whom were given cefamandole and 150, a placebo. The two groups were
similar in terms of mean age, sex ratio, duration of preoperative hospital
stay, underlying risk factors, and type of surgical procedure. A
superficial wound infection developed in none of the 134 patients who were
given cefamandole and in seven of those in the control group (p less than
0.05). Two deep-wound infections developed in the cefamandole-treated group
and four, in the control group (p greater than 0.05). Staphylococcus
aureus, Staphylococcus epidermidis, and gram-negative bacilli were the most
common infecting organisms. The rates of infection-related mortality and
abscopal infection were similar in both groups. No adverse side effects of
the drug were encountered.