Placement of an antibiotic oral pack on the hard palate after primary cleft palatoplasty: a randomized controlled trial into the effect on fistula rates

OBJECTIVE: The objective of this study is to determine whether placement of an antibiotic oral pack on the hard palate reduces fistula rates after primary cleft palatoplasty. SUBJECTS AND METHODS: This study was a parallel blocked randomized controlled trial. The study consisted of two groups of 100 patients each with non-syndromic unilateral complete cleft lip, alveolus, and hard and soft palate that underwent primary palatoplasty. Group A had an oral pack placed on the hard palate for 5 days postoperatively while group B did not. Occurrence of fistulae between both groups was tested using odds ratios (OR). RESULTS: In 2% of the patients in group A, a fistula was found 6 months after palatal surgery. In contrast, in 21% of the patients in group B, a palatal fistula could be confirmed. The fistula occurrence in group A was statistically significantly lower than that in group B (OR = 0.0768, CI = [0.02 … 0.34], p < 0.001). CONCLUSION: The findings of this study provide evidence that the rate of fistula formation after primary palatoplasty is significantly reduced if a pack soaked with antibiotic cream is placed on the palate postoperatively for 5 days. CLINICAL RELEVANCE: The use of an antibiotic pack after cleft palate repair can be recommended to prevent occurrence of oronasal fistulae.