The Impact of Preoperative Antibiotic Use in Primary Palatoplasty. An Outcome Study Utilizing the Pediatric Health Information System (PHIS) Database
Diana Jodeh, MD1, James J. Cray, PhD2, S. Alex Rottgers, MD1.
1John Hopkins All Children's Hospital, St.Petersburg, FL, USA, 2Medical University of South Carolina, Charleston, SC, USA.
PURPOSE: Previous 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 or healthcare alliances.
METHODS: We queried the Pediatric Health Information System (PHIS) database for de-identified billing records. This meta-dataset was accumulated from 47 participating children's hospitals. We identified patients within the PHIS database who had undergone primary palatoplasty, ICD-9 code 749.21, between 2007 and 2012. Patients between 6-18 months old at the time of surgery were included. We determined how many of these patients had undergone repair of an oronasal fistula, ICD-9 procedure code 21.82, between 2007 and 2015. Pharmacy billing records for each patient were queried for charges for antibiotic administration. Our primary analysis consisted of two groups. Group 1 received no preoperative antibiotics. Group 2 received a dose of preoperative antibiotics. Our secondary analysis also consisted of 2 groups. Group 1 received no antibiotics. Group 2 received preoperative and/or postoperative antibiotics during their hospital admission. Chi-square one-sample hypotheses tests were completed using Statistical Analysis System (SAS) software. With our sample size, we were powered to detect a 2% difference in fistula rates between groups.
RESULTS: 6941 patients were identified who underwent primary palatoplasty between 6-18 months of age during the study period. 5992 (86%) patients received a dose of preoperative antibiotics and 216 (3.6%) of these underwent subsequent fistula repairs. 949 (14%) patients did not receive preop antibiotics, and 26 (2.7%) underwent fistula repair. The difference between Group 1 and 2 was not significant (p=0.163). Within the secondary analysis, 6323 patients received preoperative and/ or postoperative antibiotics; 227 of those patients (3.6%) had a subsequent fistula repair. 618 patients received no antibiotics, and 17 (2.75%) of these underwent fistula repair. The difference in the rate of developing fistulae is not statistically different between the two groups (p=0.188).
CONCLUSION: The primary endpoint of primary palatoplasty is the successful repair of the cleft without an oronasal fistula. In an attempt to limits of inadequate power in previous studies, we are reporting a series of 6941 palatoplasties from 47 hospitals within the PHIS database. A small, but not statistically significant increase in fistula rate was seen in patients who received antibiotics indicating that antibiotic use likely has little or no effect on the rate of fistula formation. Their use can be considered for other clinical indications.
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