What is the Tympanic Membrane Healing Time After Insertion of a Gelfoam PE Tube?

Study Overview
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Brief Summary
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Pilot study done to evaluate the breakdown and and potential utility of a bioabsorbable ventilation ear tube made with gelatin.

Detailed Description
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Institutional Review Board- Park Nicollet Institute approval was granted 3/2011 for 15 patients to be enrolled in pilot study of use of a bioabsorbable ventilation ear (PE) tube. IRB stated compliance with FDA as defined in 21 CFR, Part 56 and with regulations of DHHS. Federal assurance number FWA00000914. Prior to commencing this study, IRB approval was obtained and each participating clinician completed the NIH training for Protecting Human Research Participants. 14 patients (15 ears) were enrolled in this study and were examined by 2 independent examiners at approximately 3, 6 and 12 week follow-ups. Lumen patency and time to complete resorption were documented by each examiner. There were no adverse reactions. This pilot study suggests that there is utility for a bioabsorbable ear tube made from gelatin material, as the device was found to break down over the expected time frame and remained functional long enough to have clinical utility.

Official Title
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What is the Tympanic Membrane Healing Time After Insertion of a Gelfoam PE Tube?

Conditions
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Eustachian Tube Dysfunction, Sudden Hearing Loss, Meniere Disease

Intervention / Treatment
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* Device: PE tube


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: meeting indications for placement of a short or intermediate-duration ventilation ear tube (PE tube) Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 26 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: 14 patients underwent placement of a novel absorbable ventilation tube to test utility of this prototype device and monitor resorption over a period of weeks. 14 participants were approved for this study of feasibility to allow for patients who did not follow up per the study protocol.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meeting indication for short term ventilation tube placement<br>Adult patients meeting standard criteria for short-term ventilation tube placement were offered placement of a bioabsorbable ear tube in place of a durable ear tube that would later be removed. | Device: PE tube<br>* Gelatin mixed with antibiotic and steroid ear drop to create a rigid device that maintains a lumen, acting as an intermediate-duration bioabsorbable ear tube.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of weeks that ventilation tube lumen is patent. | Primary outcome was presence of a lumen, reflecting a functional device. | 0-3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of weeks until ventilation tube is fully resorbed. | Gelatin has been used in this site as packing material and has been shown to resorb over a period of several weeks. Full resorption of this device is expected. | 0-3 months |