Administration of Single-Dose Antibiotic Does Not Decrease Oronasal Fistula Rates After Primary Palatoplasty

Abstract

Objective: Oronasal fistula (ONF) is a known complication after primary palatoplasty (PP). Studies investigating the effect of perioperative antibiotics on fistula rates after PP are limited by inadequate sample size or reliance on self-reporting through national databases. In this study, the authors evaluated the association between single-dose perioperative antibiotics and postoperative fistula rates after PP at a single institution. Design: A retrospective study. Participants: Children younger than 2 years who underwent PP from April 2009 to September 2019 were included. Interventions: Patients were divided into 2 categories: Group 1 received a single intraoperative dose of IV antibiotic, while group 2 did not. Main Outcome Measure(s): Outcome measures included ONF formation, length of stay (LOS), and 30-day readmission rates. Multivariable firth logistic regression, quantile regression, and χ2 tests were performed. Results: Of the 424 patients, 215 and 209 patients were in groups 1 and 2, respectively. The overall ONF rate was 1.9% among all patients. Patients in group 1 experienced an ONF rate of 3.3%, while patients in group 2 had an ONF rate of 0.5%. After correcting for confounding variables, the difference in ONF rates was not statistically different ( P = .68). Median LOS was 35.7 hours and 35.5 hours ( P = .17), while the rate of readmission within 30 days was 4.7% and 2.4% for group 1 and 2, respectively ( P = .96). Conclusions: Administration of a single-dose perioperative antibiotic did not decrease fistula formation after PP, nor did it affect the patient’s LOS or 30-day readmission rate.

Patient Safety and Quality Improvement Initiatives in Cleft Lip and Palate Surgery: A Systematic Review

“…Jodeh et al42 found that cleft palate patients who received preoperative antibiotics experienced lower rates of fistula (2.7% versus 3.6%; P =0.163). Mamidi et al43 found rates of fistula formation, 30-day readmission, and length of stay to be similar in patients who received a single intraoperative dose of antibiotics during primary palatoplasty compared with patients who did not. Two articles investigated the utility of microbiological swabs at the time of cleft lip and palate surgery 44,45.…”

“…Pfaff et al 41 concluded that evidence appeared unclear toward the benefit of postoperative antibiotics in cleft palate surgery. Similarly, Mamidi et al 43 found no benefit to single-dose intraoperative antibiotics in reducing fistulae. These findings are supported by an earlier review by Rottgers et al 71 who found that preoperative antibiotics provided little-to-no benefit in preventing postoperative infections and fistulae in cleft palate surgery, but suggested that a single prophylactic dose may still serve to prevent rare, potentially severe, infections.…”

“…38,39 Fistula Formation and Infection Of the 7 articles (Supplemental Table 6, Supplemental Digital Content 6, http://links.lww.com/SCS/E643) that investigated the topic of fistula formation and infection, 4 examined the effect of antibiotics on rates of surgical complications, including wound breakdown and fistula formation. [40][41][42][43] Aznar et al 40 found that postoperative antibiotics (5 d, 50 mg/kg/d) compared with placebo resulted in less complication rates (8.7% versus 13.8%; P = 0.175) and fistula rates (10.7% versus 17.1%; P = 0.085) in cleft palate surgery. Pfaff et al 41 on the other hand found unclear evidence through a systematic review to support the use of prolonged postoperative antibiotics in cleft palate surgery.…”