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

Launched by BOSTON CHILDREN'S HOSPITAL · Aug 30, 2018

Keywords

ClinConnect Summary

This clinical trial is studying whether using special ear drops during and after tympanostomy tube surgery can help improve outcomes for children who don’t have fluid in their middle ear at the time of the surgery. The surgery is often done to treat frequent ear infections. Researchers want to see if these drops can reduce problems like the tubes getting blocked or drainage from the ear in the first four weeks after surgery. In this study, children aged 6 months to 10 years who are having the surgery for both ears may be eligible, as long as they don’t have any ear fluid or other specific health issues.

If a child participates, they will receive the ear drops in one ear during the surgery and after, while the other ear will not receive the drops. The researchers will track how well the tubes work and whether there’s any drainage from the ear over the following month. It's important to note that children who are having other procedures at the same time or have certain medical conditions won’t be included in the study. Overall, this trial aims to find better ways to ensure successful surgery for kids with ear problems.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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