Cefotaxime single-dose surgical prophylaxis in a prepaid group practice. Comparisons with other cephalosporins and ticarcillin/clavulanic acid.

The prophylactic efficacy of a single 1g dose of cefotaxime for a wide variety of clean and clean-contaminated surgical procedures was studied in a large prepaid medical practice setting. Regimens were evaluated in 3 successive prospective, randomised comparative trials involving 1950 evaluable patients between November 1983 and March 1986. Single-dose cefotaxime was initially compared with standard multiple-dose regimens of cephazolin and cefoxitin, and subsequently used as the control regimen for comparisons with single-dose cefoperazone and ticarcillin/clavulanic acid. Patients were observed for the development of wound infection, non-wound morbidity, and adverse reactions. The single-dose prophylaxis regimens resulted in fewer surgical wound infections (p less than 0.05) compared with multi-dose prophylaxis if colorectal procedures were excluded from the analyses. The limited effectiveness of single-dose prophylaxis in colorectal surgery occurred despite the co-administration of erythromycin and neomycin. More than half the infections in all groups were discovered after hospital discharge and were inconsequential. Organisms isolated from the various infections generally remained susceptible to the administered antimicrobial agents. Adverse reactions occurred significantly (p less than 0.001) less often in the patients receiving single-dose prophylaxis. Non-wound morbidity was comparable in all trial groups. The costs associated with single-dose regimens were much lower than those of the FDA-approved multiple-dose regimens. These data confirm that single-dose, broad spectrum beta-lactam agents such as cefotaxime provide safe, effective and economical prophylaxis for a wide variety of surgical procedures.

RCT Entities:   Population Interventions Outcomes