Otiprio Versus Ciprodex Tympanostomy Tube Outcomes

• Status: Withdrawn
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Medical Center
• Treatments: BB 1101; Ciprofloxacin; Dexamethasone; Dexamethasone acetate

Criteria

Inclusion Criteria:

• Children (6 months to 10 years)

• Clinical diagnosis of bilateral middle ear effusion or recurrent acute otitis media requiring tympanostomy tube placement

Exclusion Criteria:

• Patient having any other concurrent surgery

• History of mastoid surgery, chronic or recurrent bacterial infections

• Tympanic membrane perforations

• History of immunodeficiency disease

• Abnormalities of the tympanic membrane or middle ear

• Otic or systemic corticosteroid within 7 days of surgery

• Topical or systemic antimicrobials or antifungal agents prior to their particular washout intervals

• Concurrent use of anti-inflammatory agents

• Allergy to the medications used in this study and their components

• Menarcheal or postmenarcheal female.