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

Who is this study for? Child patients with Otitis Media
What treatments are being studied? Ofloxacin Otic Solution
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 10
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Boston Children's Hospital at Waltham
RECRUITING
Waltham
Contact Information
Primary
Kenneth R. Whittemore, MD, MS
Kenneth.Whittemore@childrens.harvard.edu
(617)-355-2880
Backup
Brian Boudreau, PA-C
Brian.Boudreau@childrens.harvard.edu
(617)-355-2880
Time Frame
Start Date: 2019-05-16
Estimated Completion Date: 2026-09
Participants
Target number of participants: 125
Treatments
Experimental: Treatment Ear
Participants will serve their own control. Participants will receive 3 drops of ofloxacin otic solution intra- and post-operatively 3 times per day for 3 days in ONE ear. Ear sidedness will be randomized by participant.
No_intervention: No Intervention
Participants will serve their own control. Participants will receive no intervention in the ear contralateral to the treated ear. Ear sidedness will be randomized by participant.
Sponsors
Leads: Boston Children's Hospital

This content was sourced from clinicaltrials.gov