Status:
WITHDRAWN
Otiprio Versus Ciprodex Tympanostomy Tube Outcomes
Lead Sponsor:
Boston Medical Center
Conditions:
Otorrhea
Otitis Media With Effusion in Children
Eligibility:
All Genders
6-10 years
Phase:
PHASE4
Brief 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 effe...
Detailed Description
Tympanostomy tube placement is indicated in children with recurrent acute otitis media or chronic otitis media with effusion. Ear dishcarge, otorrhea, is the most common complication following tympano...
Eligibility Criteria
Inclusion
- Children (6 months to 10 years)
- Clinical diagnosis of bilateral middle ear effusion or recurrent acute otitis media requiring tympanostomy tube placement
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03347461
Start Date
October 1 2018
End Date
June 1 2019
Last Update
September 14 2018
Active Locations (1)
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1
Boston Medical Center
Boston, Massachusetts, United States, 02118