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

NCT03655665 | Recruiting Phase 4

• 1 other identifier: P00026372
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Otitis Media

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with tympanostomy tube occlusion

  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.

  0-35 days post-op

Secondary Outcomes (1)

• Percentage of patients with otorrhea (drainage from the ear)

  0-35 days post-op

Study Arms (2)

Treatment Ear

EXPERIMENTAL

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

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.

Interventions

Ofloxacin otic solution DRUG

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

Also known as: Floxin Otic

Treatment Ear

Eligibility Criteria

• Age: 6 Months - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital at Waltham

Waltham, Massachusetts, 02453, United States

RECRUITING

Related Publications (10)

• Rosenfeld RM, Schwartz SR, Pynnonen MA, Tunkel DE, Hussey HM, Fichera JS, Grimes AM, Hackell JM, Harrison MF, Haskell H, Haynes DS, Kim TW, Lafreniere DC, LeBlanc K, Mackey WL, Netterville JL, Pipan ME, Raol NP, Schellhase KG. Clinical practice guideline: Tympanostomy tubes in children. Otolaryngol Head Neck Surg. 2013 Jul;149(1 Suppl):S1-35. doi: 10.1177/0194599813487302.

  PMID: 23818543 BACKGROUND

• Kay DJ, Nelson M, Rosenfeld RM. Meta-analysis of tympanostomy tube sequelae. Otolaryngol Head Neck Surg. 2001 Apr;124(4):374-80. doi: 10.1067/mhn.2001.113941.

  PMID: 11283489 BACKGROUND

• van Dongen TM, van der Heijden GJ, Freling HG, Venekamp RP, Schilder AG. Parent-reported otorrhea in children with tympanostomy tubes: incidence and predictors. PLoS One. 2013 Jul 12;8(7):e69062. doi: 10.1371/journal.pone.0069062. Print 2013.

  PMID: 23874870 BACKGROUND

• Jeon EJ, Park YS, Lee SK, Chang KH, Park SY, Park KH, Lee DH. Factors of the blockage of ventilation tubes in the immediate postoperative period. Eur Arch Otorhinolaryngol. 2007 Dec;264(12):1393-7. doi: 10.1007/s00405-007-0375-0. Epub 2007 Jul 27.

  PMID: 17657506 BACKGROUND

• Jamal TS. Avoidance of postoperative blockage of ventilation tubes. Laryngoscope. 1995 Aug;105(8 Pt 1):833-4. doi: 10.1288/00005537-199508000-00012.

  PMID: 7543180 BACKGROUND

• Schmelzle J, Birtwhistle RV, Tan AK. Acute otitis media in children with tympanostomy tubes. Can Fam Physician. 2008 Aug;54(8):1123-7.

  PMID: 18697973 BACKGROUND

• Conrad DE, Levi JR, Theroux ZA, Inverso Y, Shah UK. Risk factors associated with postoperative tympanostomy tube obstruction. JAMA Otolaryngol Head Neck Surg. 2014 Aug;140(8):727-30. doi: 10.1001/jamaoto.2014.1176.

  PMID: 25009981 BACKGROUND

• Ramadan HH, Tarazi T, Zaytoun GM. Use of prophylactic otic drops after tympanostomy tube insertion. Arch Otolaryngol Head Neck Surg. 1991 May;117(5):537. doi: 10.1001/archotol.1991.01870170083018.

  PMID: 2021473 BACKGROUND

• Burke EL, Walvekar RR, Lin J, Hagan J, Kluka EA. Common agents used to unblock blood clots within tympanostomy tubes: an ex vivo study and review of literature. Int J Pediatr Otorhinolaryngol. 2009 Dec;73(12):1725-8. doi: 10.1016/j.ijporl.2009.09.009. Epub 2009 Sep 30.

  PMID: 19796828 BACKGROUND

• Giles W, Dohar J, Iverson K, Cockrum P, Hill F, Hill N. Ciprofloxacin/dexamethasone drops decrease the incidence of physician and patient outcomes of otorrhea after tube placement. Int J Pediatr Otorhinolaryngol. 2007 May;71(5):747-56. doi: 10.1016/j.ijporl.2007.01.012. Epub 2007 Feb 20.

  PMID: 17316832 BACKGROUND

MeSH Terms

Conditions

Otitis Media

Interventions

Ofloxacin

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Kenneth R. Whittemore, MD, MS

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Otolaryngologist/Assistant Professor of Otolaryngology

Model Details: Clinical effectiveness model. Each subject will serve as their own control. Subject's ears will be randomized.

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: August 31, 2018
• Study Start: May 16, 2019
• Primary Completion: September 1, 2024
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)