RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2019-05-16
Study Completion:2026-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03655665

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Months to 10 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Participant has a history of Eustachian tube dysfunction (ETD) or recurrent acute otitis media (AOM) requiring surgery for bilateral TT placement
  2. * Participant's caregiver understands the protocol and is willing to comply with the protocol
  3. * Children ages 6 months to 10 years undergoing surgery for bilateral tympanostomy tube placement without middle ear fluid on the day of their surgery
  1. * Participant is having concomitant procedures performed at the time of their tympanostomy tube surgery (i.ei.e. adenoidectomy, airway endoscopy, nasal cautery).
  2. * Historyof conductive hearing loss, as determined from their last audiogram prior to tympanostomy tube procedure
  3. * Middle ear effusion present in either their left or right ear on the day of tympanostomy tube surgery
  4. * Current diagnosis of craniofacial abnormalities, Trisomy 21, primary ciliary dyskinesia, cystic fibrosis
  5. * History of a known immunodeficiency disease

Contacts and Locations

Study Contact

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

Principal Investigator

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

Study Locations (Sites)

Boston Children's Hospital at Waltham
Waltham, Massachusetts, 02453
United States

Collaborators and Investigators

Sponsor: Boston Children's Hospital

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-05-16
Study Completion Date2026-09

Study Record Updates

Study Start Date2019-05-16
Study Completion Date2026-09

Terms related to this study

Additional Relevant MeSH Terms

  • Otitis Media