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.

Effect of antibiotic pack on hard palate after fistula closure on nasal airflow and reoccurrence rate.

This parallel blocked randomized controlled trial was done in two groups of 30 patients each to determine if placement of an antibiotic oral pack on the hard palate after hard palatal fistula repair reduces nasal air emission and fistula re-occurrence. Group A had an oral pack on the hard palate for 5 days post-operatively while group B did not. In group A, percentage of nasal air emission was tested using nasometry with and without pack. Paired t-tests were performed to compare nasal emissions for patients with and without pack. Recurrence of fistulas after 6 months between group A and B was tested using odds ratio. Effect of nasal air emission on fistula rates was tested using paired t-tests. There was a significant increase (p < 0.0001) in nasal emission after removal of the pack in group A. Fistula re-occurrence tended to be higher in group B (no pack) than group A but this was not significant (p = 0.242). There was no correlation between nasal air emission and fistula rates. In patients with recurrent fistulae, placement of an oral pack after fistula repair diminishes nasal air emission. Whether this has an impact on re-occurrence of fistulae needs to be investigated further.