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

NCT03655665 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2024-07-09

No results posted yet for this study

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.

Conditions

  • Otitis Media

Interventions

DRUG

Ofloxacin otic solution

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

Sponsors & Collaborators

Principal Investigators

  • Kenneth R. Whittemore, MD, MS · Boston Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-16
Primary Completion
2024-09-30
Completion
2026-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03655665 on ClinicalTrials.gov