Role of Postoperative Antimicrobials in Cleft Palate Surgery: Prospective, Double-Blind, Randomized, Placebo-Controlled Clinical Study in India.

Abstract

The purpose of this study was to determine whether administration of postoperative antibiotics affects the incidence of complications after primary cleft palate repair in a developing area. This study was a prospective, double-blind, randomized, placebo-controlled trial composed of 518 consecutive patients who underwent primary cleft palate repair at a single institution. Patients were aged 1 to 43 years at the time of surgery (median, 9 years). The patients were divided randomly into two groups. One group received a 5-day regimen of oral amoxicillin (50 mg/kg/day) postoperatively and the other group received placebo medication. Both groups received a single dose of cefuroxime (30 mg/kg) before incision. Patients and providers were blinded to the randomization. Patients were followed postoperatively for early complications (infection and wound breakdown) and for late complications (palatal fistulas). The incidence of early complications was 13.8 percent among the patients in the placebo group and 8.7 percent among the patients in the antibiotic group (p = 0.175). Fistulas were noted in 17.1 percent in the placebo group and in 10.7 percent in the antibiotic group (p = 0.085). Logistic regression analysis identified visiting surgeons as the only covariate related to early complications (OR, 3.71; p < 0.001). However, the use of placebo (OR, 2.09; p = 0.037), female sex (OR, 2.04; p = 0.047), and Veau III and IV (OR, 3.31; p = 0.004) were observed as factors associated with the incidence of fistulas. The authors' results indicate that postoperative antibiotic prophylaxis can reduce the incidence of fistulas after primary cleft palate repair in a developing area.