RESUMEN
OBJECTIVES/HYPOTHESIS: Antimicrobial prophylaxis is still a matter of debate in ear surgeries. Previous studies have focused on prophylaxis in middle ear surgery alone without inclusion of mastoidectomy. We therefore investigated efficacy of two regimes of antimicrobial prophylaxis in tympanoplasty with cortical mastoidectomy done for mild middle ear disease in chronic otitis media. STUDY DESIGN: Prospective, randomized, controlled, double-blind study. METHODS: Patients undergoing tympanoplasty with cortical mastoidectomy were included and randomized into two study groups. The group I patients received parenteral perioperative antimicrobials; only group II patients received additional extended oral antimicrobials for 8 days more postoperatively. Primary outcomes evaluated were postaural wound infection and graft success, assessed weekly until 1 month. Adverse events and length of hospital stay were evaluated as secondary outcome. RESULTS: Seventy-eight patients were randomized into group I (n = 39) and group II (n = 39). The two groups showed no difference in wound infection rate. The graft success rate in both the group was comparable (94.87% in group I and 97.44% in group II, respectively; P = 1.00). The length of hospital stay was significantly longer (P = 0.00001) in group II (3.05 [0.72], mean [SD]) as compared to group I (2.36 [0.49]). During the first postoperative week, a significantly higher incidence of gastrointestinal disturbances were observed in group II (19 [48.72%] as compared to 1 [2.56%] in group I, P = 0.00001). CONCLUSION: The present study shows that there is no need of extended antimicrobial prophylaxis for tympanoplasty with cortical mastoidectomy done for mild middle ear disease. An indiscriminate use of antimicrobials may lead to increase incidence of adverse events and prolonged hospital stay. LEVEL OF EVIDENCE: 1b.