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

Skovlund Medical Products, LLC14 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Eustachian Tube Dysfunction Sudden Hearing Loss Meniere Disease

Interventions

PE tubeDEVICE

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.

Eligibility

Sex: ALLMin age: 26 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of weeks that ventilation tube lumen is patent.

Primary outcome was presence of a lumen, reflecting a functional device.

Time frame: 0-3 months

Secondary Outcomes

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.

Time frame: 0-3 months

Data from ClinicalTrials.gov

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