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

Abstract

ObjectiveThe 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 methodsThis 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).ResultsIn 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).ConclusionThe 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 relevanceThe use of an antibiotic pack after cleft palate repair can be recommended to prevent occurrence of oronasal fistulae.