Evaluation of a New Biocompatible Pressure Equalizing Tube
| Status: | Withdrawn |
|---|---|
| Conditions: | Other Indications, Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | July 2012 |
| End Date: | September 2014 |
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).
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).
The researcher at Beckman Laser Institute, University of California, Irvine, develops new
medical tool device call biocompatible Pressure Equalizing tube which can stop air passage
and pressure equalization instantly, and can prevents water into the middle ear cavity.
evaluate and compare the efficacy of a biocompatible Pressure Equalizing tube that enables
air passage and pressure equalization almost instantly, while prevents the entrance of
fluids, specially water, into the middle ear cavity.
The biocompatible Pressure Equalizing tube can reduce the rate of postoperative otorrhea,air
passage between outside and middle ear cavity,prevents formation of retraction pockets in TM
and swimming with lower risk of otorrhea.
medical tool device call biocompatible Pressure Equalizing tube which can stop air passage
and pressure equalization instantly, and can prevents water into the middle ear cavity.
evaluate and compare the efficacy of a biocompatible Pressure Equalizing tube that enables
air passage and pressure equalization almost instantly, while prevents the entrance of
fluids, specially water, into the middle ear cavity.
The biocompatible Pressure Equalizing tube can reduce the rate of postoperative otorrhea,air
passage between outside and middle ear cavity,prevents formation of retraction pockets in TM
and swimming with lower risk of otorrhea.
Inclusion Criteria:
1. Male/ female at all age- newborn to adult.
2. Non- pregnant woman.
3. Diagnose of middle ear infection and plan for surgery procedure
Exclusion Criteria:
1. Pregnant woman
2. Incompetent adults (i.e. individuals with cognitive impairment)
3. Presence of immunodeficiency; cystic fibrosis; sickle cell disease;
4. Another major systemic disease
5. Congenital malformation of the external, middle, or inner ear
6. Sensorineural hearing loss; otoneurologic disease
7. History of prior ear surgery such as tympanoplasty, tympanomastoidectomy, or
mastoidectomy; cholesteatoma; chronic mastoiditis; intratemporal or intracranial
suppurative complications of otitis media
8. Use of ototoxic medication (except topical use)
We found this trial at
1
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