Comparison of postoperative infection and graft uptake rate using single dose of intravenous co-amoxiclav versus no antibiotic in children undergoing myringoplasty: A randomized controlled trial.

ABSTRACT

OBJECTIVES: To compare postoperative infection and graft uptake rate using single dose of intravenous co-amoxiclav versus no antibiotic in children undergoing myringoplasty. METHODS: This is a prospective, randomized controlled study conducted in children of age 6-15 years with chronic otitis media (COM) mucosal, inactive type undergoing myringoplasty. Postoperative infection over a period of 4 weeks and status of graft at or around 3 months after surgery was studied as outcome measure. RESULTS: Fifty five out of sixty children completed follow-up. The overall postoperative infection rate was 5.4%. Postoperative infection rate was 3.5% in children receiving prophylactic antibiotic and 7.4% in children receiving no antibiotic. There was no statistically significant difference in postoperative infection between two groups (P > 0.05). The overall graft uptake rate was 87.27%. It was 85.7% in antibiotic used group and 88.8% in non-antibiotic group with no statistically significant difference (P > 0.05). CONCLUSIONS: Postoperative infection following myringoplasty in children is uncommon as it is a clean type of surgery. There was no statistically significant difference in postoperative infection and graft uptake rate by the use of prophylactic antibiotic in the intraoperative period. This study shows no benefit of a prophylactic antibiotic on postoperative infection or graft success in myringoplasty in children. TRIAL REGISTRATION NUMBER NCT03700814.