Evaluation of a New Biocompatible Pressure Equalizing Tube
Withdrawn before enrolling · Not applicable
Conditions studied: Otitis Media
In brief
Otitis media is the most common illness in children and 5% to 10% of their symptom cause by fluids in their middle ear . The OME can cause hearing loss included poor development of speech and poor communication. The surgical procedure is considered simple and relatively safe, but several complications may occur after Pressure Equalizing tube insertion. The most prevalent complications are otorrhea, biofilm and formation of retraction pockets. Otorrhea occurs in 30% to 83% of children with tube and is mainly due bacterial contamination of the middle ear either from external ear canal or impaired Eustachian tube. Swimming can facilitate the entry of bacteria into the middle ear from the ear canal through the PE tubes, and this assumption is reinforced by the statistically significant association between the rate of otorrhea and the non-utilization of ear plugs in children who swim (from 47% in children who used ear plugs to 56% in those who did not).
Key facts
- Study ID
- NCT01775709
- Run by
- University of California, Irvine
- People needed
- 0
- Starts
- 2012-07-01
- Expected to finish
- 2014-09-01
- Last updated by the study team
- 2022-11-01
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male/ female at all age- newborn to adult.
- Non- pregnant woman.
- Diagnose of middle ear infection and plan for surgery procedure
You may not qualify if…
- Pregnant woman
- Incompetent adults (i.e. individuals with cognitive impairment)
- Presence of immunodeficiency; cystic fibrosis; sickle cell disease;
- Another major systemic disease
- Congenital malformation of the external, middle, or inner ear
- Sensorineural hearing loss; otoneurologic disease
- History of prior ear surgery such as tympanoplasty, tympanomastoidectomy, or mastoidectomy; cholesteatoma; chronic mastoiditis; intratemporal or intracranial suppurative complications of otitis media
- Use of ototoxic medication (except topical use)
Where it is running
- UCIMC — Orange, California, United States
Full record on ClinicalTrials.gov
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