Does Topical Otic Drop Use at Time of Tympanostomy Tube Surgery Improve Outcomes When no Middle Ear Effusion is Present

Stopped early · Phase 4

Conditions studied: Otitis Media

In brief

To determine whether the use of topical otic drops intra-operative and post-operative during tympanostomy tube placement reduces the rate of tympanostomy tube occlusion and post-operative otorrhea (ear drainage) during the initial 4-week post-operative period in subjects with no middle ear effusion (fluid behind the ear drum) present at the time of surgery. A within subject controlled study design will be utilized to study this effect. Subjects with absent middle ear effusion who are receiving tympanostomy tube placement will receive a standard protocol of Floxin topical drops during surgery and after surgery in one ear. Selection of ear (right ear or left ear) will be randomized. The primary measured outcome will be the rate of tympanostomy tube occlusion within first 4 weeks postoperatively. The secondary measured outcome is the rate of tympanostomy tube otorrhea (drainage) within first 4 weeks postoperatively.

Key facts

Study ID

NCT03655665

Run by

Boston Children's Hospital

People needed

9

Starts

2019-05-16

Expected to finish

2024-08-06

Last updated by the study team

2026-06-17

Who can join

Age: 1 and older, up to 10. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant has a history of Eustachian tube dysfunction (ETD) or recurrent acute otitis media (AOM) requiring surgery for bilateral TT placement
• Participant's caregiver understands the protocol and is willing to comply with the protocol
• Children ages 6 months to 10 years undergoing surgery for bilateral tympanostomy tube placement without middle ear fluid on the day of their surgery

You may not qualify if…

• Participant is having concomitant procedures performed at the time of their tympanostomy tube surgery (i.ei.e. adenoidectomy, airway endoscopy, nasal cautery).
• Historyof conductive hearing loss, as determined from their last audiogram prior to tympanostomy tube procedure
• Middle ear effusion present in either their left or right ear on the day of tympanostomy tube surgery
• Current diagnosis of craniofacial abnormalities, Trisomy 21, primary ciliary dyskinesia, cystic fibrosis
• History of a known immunodeficiency disease

Where it is running

• Boston Children's Hospital at Waltham — Waltham, Massachusetts, United States

Full record on ClinicalTrials.gov

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