Actively Recruiting
Does Topical Otic Drop Use at Time of Tympanostomy Tube Surgery Improve Outcomes When no Middle Ear Effusion is Present
Led by Boston Children's Hospital · Updated on 2024-07-09
125
Participants Needed
1
Research Sites
380 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Does Topical Otic Drop Use at Time of Tympanostomy Tube Surgery Improve Outcomes When no Middle Ear Effusion is Present
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Child has a history of Eustachian tube dysfunction or recurrent acute otitis media needing bilateral tympanostomy tubes
- Caregiver understands the study and agrees to follow the protocol
- Child is between 6 months and 10 years old and scheduled for bilateral tympanostomy tube surgery without middle ear fluid at surgery
You will not qualify if you...
- Child is having other procedures during tube surgery (e.g., adenoidectomy, airway endoscopy, nasal cautery)
- History of conductive hearing loss based on last audiogram before surgery
- Presence of middle ear fluid in either ear on surgery day
- Diagnosis of craniofacial abnormalities, Trisomy 21, primary ciliary dyskinesia, or cystic fibrosis
- History of known immunodeficiency disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Boston Children's Hospital at Waltham
Waltham, Massachusetts, United States, 02453
Actively Recruiting
Research Team
K
Kenneth R. Whittemore, MD, MS
CONTACT
B
Brian Boudreau, PA-C
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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