Does intraoperative ciprofloxacin-soaked gelfoam have adverse effects on graft success rate? A randomized, double-blind controlled trial

Abstract

Objectives: The aim of this study was to evaluate whether intraoperative ciprofloxacin-soaked gelfoam is safe in tympanoplasty or not. Method: In this randomized, double-blind controlled clinical study, we included 100 patients between 18 and 60 years old, having perforation ≥50% of the tympanic membrane and dry ear for at least 2 months who were a candidate for underlay tympanoplasty via postauricular approach. We used ciprofloxacin soaked gelfoam in the case group and betamethasone soaked gelfoam in the control group for packing the middle ear cavity and external auditory canal during their operation. The graft success rate and tympanogram after 6 months follow-up period was considered as the primary outcome. Also, we evaluated the postoperative hearing results 6 months after the surgery as the secondary outcomes. Results: Postoperative microscopic otoscopy showed a graft success rate of 100% (44/44) and 97.7% (42/43) in the case and control groups, respectively. The level of improvement between the two groups was not significant for air-bone gap (ciprofloxacin: 9.01 ± 7.89 dB, betamethasone 5.31 ± 10.53 dB, P =.160), and speech reception thresholds (SRT; ciprofloxacin: 10.23 ± 8.62 dB, betamethasone 7.33 ± 12.60 dB, P =.260). 93.2% of all the ears in the case group and 81.4% of those in the control group achieved postoperative air-bone gap within 20 dB, but the difference between them was not significant (P =.118). Conclusions: We found that the application of ciprofloxacin impregnated gelfoam in the middle ear, and the external auditory canal had no adverse effect on the graft success rate in tympanoplasty. Levels of evidence: 1b.