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

Part of paid clinical trials in Waltham, Massachusetts.

Sponsor
Boston Children's Hospital
Study ID
NCT03655665
Phase
PHASE4
Status
Recruiting
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Conditions

  • Otitis Media

Eligibility Criteria

Sex
ALL
Age
6 Months - 10 Years
Healthy Volunteers
Not accepted

Interventions

  • Ofloxacin otic solution — DRUG
    Three drops of ofloxacin otic 0.3%. intra and post-operatively for 3 days post-surgery on one ear.

Study Details

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 Dates

Start date
May 16, 2019
Status verified
Jul 2024
Primary completion
Sep 30, 2024
Completion
Sep 30, 2026

Study Design

Enrollment
125 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • 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.

Primary Outcome Measure

Percentage of patients with tympanostomy tube occlusion [ Time Frame: 0-35 days post-op ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Children's Hospital at WalthamWalthamMassachusetts02453
Jenna Dargie, MS
[email protected]
781-216-2797

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Boston Children's Hospital at Waltham· Waltham, MA

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