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

Otitis Media Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03655665
• Other study ID #: P00026372
• Status: Recruiting
• Phase: Phase 4
• Start date: May 16, 2019
• Est. completion date: September 2025

Study information

• Verified date: May 2023
• Source: Boston Children's Hospital
• Contact: Kenneth R. Whittemore, MD, MS
• Phone: (617)-355-2880
• Email: Kenneth.Whittemore[@]childrens.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 125
• Est. completion date: September 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Otitis Media
• Otitis Media with Effusion

Intervention

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

Locations

Country	Name	City	State
United States	Boston Children's Hospital at Waltham	Waltham	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of patients with otorrhea (drainage from the ear)	Any drainage of liquid from the ear. Can be clear, bloody, or purulent	0-35 days post-op