Overview

Otiprio Versus Ciprodex Tympanostomy Tube Outcomes

Status:
Withdrawn
Trial end date:
2019-06-01
Target enrollment:
Participant gender:
Summary
Otolaryngologists routinely administer ear drops at the time of tympanostomy tube placement in order to prevent tube otorrhea; however, there is a lack of consensus as to which drops are the most effective, and whether a post-operative regimen should be used. Utilizing drops postoperatively places the onus of administration on parents who may have various difficulties in delivering the drops to their child's ears. Additionally, prescribing drops postoperatively is a health care cost. The purpose of this study is to determine if there is a difference in prevention of tympanostomy tube failure (defined as tube blockage or otorrhea) between Otiprio administered once intraoperatively, Ciprodex otic dropgs administered once intraoperatively, and Ciprodex otic drops administered intraoperatively with a postoperative course.
Phase:
Phase 4
Details
Lead Sponsor:
Boston Medical Center
Treatments:
BB 1101
Ciprofloxacin
Dexamethasone
Dexamethasone acetate