title: Role of Postoperative Antimicrobials in Cleft Palate Surgery: Prospective, Double-Blind, Randomized, Placebo-Controlled Clinical Study in India.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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).
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  The authors' results indicate that postoperative antibiotic prophylaxis can reduce the incidence of fistulas after primary cleft palate repair in a developing area.
authors.affiliation: Barcelona, Spain; Malmö, Sweden; and Virginia Beach, Va. From Servei de Malalties Infeccioses and Servei de Anestesiologia i Reanimació, Hospital Universitari Valld'Hebron, Universitat Autónoma de Barcelona, Department of Medicine; Department of Plastic and Reconstructive Surgery, Skåne University Hospital; and Operation Smile.
authors.forename: María Luisa
authors.initials: ML
authors.lastname: Aznar
authors.forename: Bjorn
authors.initials: B
authors.lastname: Schönmeyr
authors.forename: Gastón
authors.initials: G
authors.lastname: Echaniz
authors.forename: Lismore
authors.initials: L
authors.lastname: Nebeker
authors.forename: Lisa
authors.initials: L
authors.lastname: Wendby
authors.forename: Alex
authors.initials: A
authors.lastname: Campbell
mesh_terms: D000293:Adolescent; D000328:Adult; D000658:Amoxicillin / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D019072:Antibiotic Prophylaxis; D002648:Child; D002675:Child, Preschool; D002972:Cleft Palate / Q000601:surgery*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D015994:Incidence; D007194:India; D007223:Infant; D016015:Logistic Models; D008297:Male; D011182:Postoperative Care / Q000379:methods*; D011183:Postoperative Complications / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D011446:Prospective Studies; D012307:Risk Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D000658:Amoxicillin