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

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ClinicalTrials.gov Identifier: NCT03655665
Recruitment Status : Not yet recruiting
First Posted : August 31, 2018
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
Kenneth Whittemore, Boston Children’s Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Otitis Media Drug: Ofloxacin otic solution Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Clinical effectiveness model. Each subject will serve as their own control. Subject's ears will be randomized.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

Arm Intervention/treatment
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.
Drug: Ofloxacin otic solution
Three drops of ofloxacin otic 0.3%. intra and post-operatively for 3 days post-surgery on one ear.
Other Name: Floxin Otic

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 Measures :
  1. Percentage of patients with tympanostomy tube occlusion [ Time Frame: 0-35 days post-op ]
    Any non-"large volume" ear canal volume (less than 1.00cc volume) measurement at 4 week visit, in conjunction with physical examination notable for occluded TT, would be consistent with tube occlusion.


Secondary Outcome Measures :
  1. Percentage of patients with otorrhea (drainage from the ear) [ Time Frame: 0-35 days post-op ]
    Any drainage of liquid from the ear. Can be clear, bloody, or purulent



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Ages Eligible for Study:   6 Months to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03655665


Contacts
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Contact: Kenneth R. Whittemore, MD, MS (617)-355-2880 Kenneth.Whittemore@childrens.harvard.edu
Contact: Brian Boudreau, PA-C (617)-355-2880 Brian.Boudreau@childrens.harvard.edu

Sponsors and Collaborators
Boston Children’s Hospital
Investigators
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Principal Investigator: Kenneth R. Whittemore, MD, MS Boston Children’s Hospital

Publications:

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Responsible Party: Kenneth Whittemore, Associate Otolaryngologist/Assistant Professor of Otolaryngology, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT03655665     History of Changes
Other Study ID Numbers: P00026372
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Otitis Media
Otitis Media with Effusion
Otitis
Ear Diseases
Otorhinolaryngologic Diseases
Ofloxacin
Levofloxacin
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors