The use of prophylactic antibiotic prior to primary palatoplasty is not associated with lower fistula rates: an outcome study utilizing the Pediatric Health Information System (PHIS) Database.

Abstract

BACKGROUND\nPrevious attempts to study the effect of prophylactic antibiotics on the outcomes of cleft palate surgery have been hampered by the need for a very large sample size to provide adequate power to discern a potentially small therapeutic effect. This limitation can be overcome by querying large databases created by healthcare governing bodies.\n\n\nMETHODS\nData from the Pediatric Health Information System (PHIS) database was utilized for this analysis. Patients, 6-18 months, who had undergone primary palatoplasty (ICD-9 code 27.62) between 2004 and 2009 were included. Subsequent repair of an oronasal fistula between 2004 and 2015 was identified by ICD-9 procedure code 21.82. Pharmacy billing records were used to determine antibiotic administration. Associations between antibiotic administration and fistula repair were assessed using random-intercept logistic regression adjusting for age, gender, race, and cleft type.\n\n\nRESULTS\n7160 patients were available for analysis; of these, 6.4% (n=460) had a subsequent repair of an oronasal fistula. Fistula rates were 5.9%, 11.4% and 5.2% among patients given pre-operative antibiotics, only post-operative antibiotics, and no antibiotics respectively (p<0.001). Multivariable analysis results showed that the odds of having an oronasal fistula among patients who were administered pre-op antibiotics did not differ significantly (statistically) from patients who did not receive antibiotics (OR 0.88, 95% CI [0.59-1.31]).\n\n\nCONCLUSION\nThe treatment goal of primary palatoplasty is the successful repair of the cleft without an oronasal fistula. Administration of preoperative antibiotics did not significantly reduce the odds of subsequent fistula repair within the same PHIS institution following primary palatoplasty.