Using ear drops during tympanostomy tube surgery to improve outcomes
Does the Use of Topical Otic Drops at the Time of Tympanostomy Tube Placement Improve Outcomes When no Middle Ear Effusion is Present at the Time of Surgery
This study is testing if using ear drops during tympanostomy tube surgery can help reduce problems like tube blockage and ear drainage in children who don’t have fluid in their ears.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 125 (estimated) |
| Ages | 6 Months to 10 Years |
| Sex | All |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 1 site (Waltham, Massachusetts) |
| Trial ID | NCT03655665 on ClinicalTrials.gov |
What this trial studies
This study investigates whether the application of topical otic drops during and after tympanostomy tube placement can reduce complications such as tube occlusion and ear drainage in children without middle ear effusion. Participants will receive Ofloxacin otic solution in one ear, while the other ear will serve as a control. The study employs a within-subject controlled design, randomizing which ear receives the treatment. The primary outcome measured will be the rate of tympanostomy tube occlusion within the first four weeks post-surgery, with secondary outcomes focusing on the incidence of post-operative ear drainage.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 months to 10 years with a history of Eustachian tube dysfunction or recurrent acute otitis media, requiring bilateral tympanostomy tube placement without middle ear fluid.
Not a fit: Patients undergoing additional surgical procedures at the same time or those with middle ear effusion or specific medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to fewer complications and lower healthcare costs for families undergoing tympanostomy tube placement.
How similar studies have performed: While previous studies have explored factors affecting tympanostomy tube outcomes, this specific approach of using topical otic drops in the absence of middle ear effusion is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Waltham, Massachusetts
- Boston Children's Hospital at Waltham — Waltham, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Kenneth R. Whittemore, MD, MS — Boston Children's Hospital
- Study coordinator: Kenneth R. Whittemore, MD, MS
- Email: Kenneth.Whittemore@childrens.harvard.edu
- Phone: (617)-355-2880
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.