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Prevalence of early post-Ventilation tube otorrhea

Prevalence of early post-ventilation tube otorrhea

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013112315496N1
Enrollment
530
Registered
2014-01-13
Start date
2006-03-21
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

post-tympanostomy otorrhea.

Interventions

Intervention 1: In the second intervention group, the patients receive oral antibiotic (amoxicillin, 50 mg/kg), three times a day for 7 days after operation. Intervention 2: In the first intervention
Treatment - Drugs
Treatment - Other
In the second intervention group, the patients receive oral antibiotic (amoxicillin, 50 mg/kg), three times a day for 7 days after operation.
In the first intervention group, the middle ear cavity of the patient is irrigates with isotonic saline until the sticky fluid cleared.
In the third intervention group, the patient recieves topical ciprofloxacin drop (ciplex, Sinadarou company ), 4 drops three times a day, for 3 days after operation.
The control group, receives no treatment.

Sponsors

Vice chancellor for research, shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 15 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: any child undergoing TT placement for COME with and without undergoing concurrent adenoidectomy based on the guide line of American Academy of Otolaryngology-Head & Neck Surgery (AAO-HNS) on diagnosis and management of OME( May 2004) that included children with OME lasting 4 months or longer with persistent hearing loss or other signs and symptoms. Exclusion criteria: allergy to penicillin; chronic sinusitis; children who had previously undergone myringotomy and/or tube insertion; cleft palate; sensory neural hearing loss; complications of otitis media; craniofacial dysmorphism; mucociliary clearance disorders; immunodeficiency and age more than 15 years old.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Post-tympanostomy otorrhea. Timepoint: 3 day, one week, 2 weeks after operation. Method of measurement: Microscopic otoscopy.

Secondary

MeasureTime frame
The middle ear status: normal, congested mucosa, or secretory(mucoid, serous, or pussy). Timepoint: Intra-operative. Method of measurement: Microscopic otoscopiy.

Countries

Iran (Islamic Republic of)

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026