Overview

This trial is active, not recruiting.

Conditions recurrent acute otitis media, otitis media with effusion with hearing impairment
Treatment insertion of a specific type of ventilation tube through the tympanic membrane
Sponsor Danderyd Hospital
Collaborator Centre for clinical research Vastmanland
Start date May 2008
End date September 2014
Trial size 400 participants
Trial identifier NCT00809601, 2008/69-31/3

Summary

There are different kinds of ear tubes that may be inserted into the tympanic membrane to relieve recurrent acute otitis and hearing impairment due to otitis media with effusion. The tubes differ in size, shape and material.

No-one knows if there are differences between the different kinds of tubes regarding complications.

The investigators' hypothesis is that there is differences between the different kinds of tubes regarding complications.

To test the investigators' hypothesis, the investigators are about to conduct a randomized controlled study of four kinds of tubes having two different material and two different shapes.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
insertion of a specific type of ventilation tube through the tympanic membrane
The ventilation tubes are tested using one type in one ear and another type as an active comparator in the other ear. The investigators will test in total 4 different kinds of tubes. Four different combinations of tubes will be tested. The first combination will test: "Shepard tube" (double flanged, Fluoroplastic) vs "Donaldson tube" (double flanged, silicone) The second combination will test: "Straight tube" (single flanged, Fluoroplastic) vs "Armstrong" (single flanged, silicone) The third combination will test: "Armstrong" (single flanged, silicone) vs "Donaldson tube" (double flanged, silicone) The fourth combination will test: "Straight tube" (single flanged, Fluoroplastic) vs "Shepard tube" (double flanged, Fluoroplastic)

Primary Outcomes

Measure
Time to complete expulsion of the ventilation tube from the tympanic membrane
time frame: 45 months

Secondary Outcomes

Measure
Persistent tympanic membrane perforation
time frame: 45 months
Need for tube extraction (pain or infection)
time frame: 45 months
Pain leading to health care contact
time frame: 45 months
Tube related ear infection
time frame: 45 months
Obstruction of the tube
time frame: 45 months
Presence of myringosclerosis
time frame: 45 months

Eligibility Criteria

Male or female participants from 1 year up to 10 years old.

Inclusion Criteria: - Children aged 1-10 planned for bilateral ventilation tubes Exclusion Criteria: - Ongoing ear infection - Previous insertion of ventilation tube

Additional Information

Official title Randomized Controlled Study of Transmyringeal Tubes
Principal investigator Magnus von Unge, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in March 2013.
Information provided to ClinicalTrials.gov by Danderyd Hospital.