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 : Recruiting

First Posted : August 31, 2018

Last Update Posted : January 28, 2021

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Sponsor:

Information provided by (Responsible Party):

Kenneth Whittemore, Boston Children's Hospital

Study Description

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

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Detailed Description:

Background and Significance: Two major factors affecting the delivery of quality patient care today are cost of care and development of antibiotic resistance. If no significant difference is found in the rate of tympanostomy tube occlusion and drainage in subects receiving ear drops after surgery and those not receiving ear drops, may help prevent the development of antibiotic resistance and could possibly reduce the cost of care for families.

Tympanostomy tube(s) (TT) insertion is the most common otolaryngologic procedure for children and adolescents who suffer from chronic otitis media. TT(s) are inserted by a surgeon through the eardrum to regulate pressure in the middle ear and to aid with ear drainage and ventilation. In order for TT(s) to ventilate the middle ear space properly, they must remain unobstructed. Otorrhea is one of the most common complications following TT(s) insertion. Previous research has suggested that various factors may lead to TT(s) occlusion, including blood, debris, purulent otorrhea and tube size. A 2014 study by Conrad et al., found that patients with the presence of middle ear effusion at the time of surgery were more likely to experience tube occlusions than patients without fluid. However, studies demonstrating the most effective treatment for preventing postoperative otorrhea and TT occlusion are limited.

How to reduce the risk of post-operative TT otorrhea and TT occlusion is a common question among otolaryngologists and researchers and the efficacy of ototopical drops has been debated for patients without middle ear fluid. There is conflicting information in the current literature about the utility of these topical otic drops in patients with dry ears on the day of surgery. A 2008 review of seven randomized controlled trials completed by Schmelzle and colleagues concluded that fluoroquinolone based topical otic drops are the most effective treatment for patients with acute otitis media and TTs when compared to systemic antibiotic treatment and placebo. However, this treatment has been long debated. A 1991 study published by Ramadan, Tarazi, and Zaytoun found that there was no statistical difference between treated vs. not treated group in the development of post-operative otorrhea; however, all of these patients had middle ear effusions at the time of TT placement. Concurrently, a 2009 ex vivo study by Burke and colleagues on clotted TT(s) found that the administration of a solution of vinegar and hydrogen peroxide produced patent tubes at a higher rate than antibiotic otic drops.

Additionally, antibiotic resistance is a growing concern when treating with oral antibiotic therapy. While the placement of tympanostomy tubes does reduce the need for oral antibiotic therapy, resistant strains of bacteria such as methicillin-resistance staphylococcus aureus (MRSA) have become more prevalent in children with tympanostomy tubes.

Given the lack of evidence-based research, the decision for usage of topical otic drops when there is no middle ear fluid present is based on the subject's medical history and clinical judgment of the treating physician. Some providers opt to use topical otic drops in the absence of middle ear effusion, and some providers forgo the use of drops intra- and/or post-operatively. When topical otic drops are used as part of standard of care they are placed bilaterally, and patients receive variable amounts of otic solution intra- and post-operatively, also based on clinician preference.

Some providers believe that the use of topical otic drops in the absence of middle ear fluid effectively lessens the potential of a post-operative negative outcome such as TT occlusion. If this is true, not using topical otic drops intra- or post-operatively exposes the patient to a higher risk of a negative surgical outcome. However, there is currently insufficient clinical evidence to support the efficacy of topical drops in that specific clinical scenario. If indeed topical otic drops do not effectively improve post-operative outcomes, then the use of them is exposing the patient to antibiotics and adding to the cost of their care unnecessarily. The goal of this present study is to demonstrate whether the use of topical ofloxacin otic drops in patients with absent middle ear effusion on the day of TT surgery impacts the development of post-operative tube otorrhea or occlusion.

In the proposed study, subjects' ears will be randomized and ofloxacin drops will be administered intra- and post-operatively in either their left or right ear, depending on treatment group. Subjects will be followed-up at their 4-week appointment to determine presence of otorrhea and patency of tubes.

Study Design

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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
Actual Study Start Date :	May 16, 2019
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

Drug Information available for: Ofloxacin Levofloxacin Ofloxacin hydrochloride

U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

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 :

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

Eligibility Criteria

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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

Contacts and Locations

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

Locations

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United States, Massachusetts
Boston Children's Hospital at Waltham	Recruiting
Waltham, Massachusetts, United States, 02453
Contact: Jenna Dargie, MS 781-216-2797 jenna.dargie@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

More Information

Publications:

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.

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

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.

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. Epub 2007 Jul 27.

Jamal TS. Avoidance of postoperative blockage of ventilation tubes. Laryngoscope. 1995 Aug;105(8 Pt 1):833-4.

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

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.

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.

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. Review.

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. Epub 2007 Feb 20.

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Responsible Party:	Kenneth Whittemore, Associate Otolaryngologist/Assistant Professor of Otolaryngology, Boston Children's Hospital
ClinicalTrials.gov Identifier:	NCT03655665
Other Study ID Numbers:	P00026372
First Posted:	August 31, 2018 Key Record Dates
Last Update Posted:	January 28, 2021
Last Verified:	January 2021
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 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

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