Clinical trial: Fibroblast Growth Factor Regeneration of Tympanic Membrane Perforations (NCT02307916)

Eligibility criteria:
Inclusion Criteria:

          1. Dry tympanic membrane perforation of greater than 3 months duration

          2. If female, post-menopausal or sterile, or if she is of child-bearing potential, must
             have a negative beta-human chorionic gonadotropin (HCG) test and must be using an
             adequate form of birth control such as birth control pills, birth control implants,
             intrauterine devices (IUDs), diaphragms or condoms.

        Exclusion Criteria:

        The presence of any of the following excludes a subject from study enrollment:

          -  Active otitis media or chronic otorrhea from the middle ear

          -  Subjects receiving radiation therapy, corticosteroids, immunosuppressive agents or
             chemotherapy

          -  Subjects who, at study entry, are taking systemic antibiotics

          -  Subjects who are immunosuppressed

          -  Subjects experiencing bacterial or viral infection or who may otherwise be febrile

          -  Life expectancy of less than 1 year

          -  Active alcohol or drug abuse within 6 months prior to study entry

          -  Significant medical condition that could prevent full participation in the procedures
             required for the study (See body of protocol for full list of exclusions)

          -  Known or suspected allergies to any components used in the study

          -  Subjects who have cholesteatoma mass in the tympanic cavity

          -  Subjects whose total perforation cannot be seen by an endoscope

          -  Subjects with inadequately controlled diabetes mellitus (NGSP: HbA1c 6.9% or higher)

          -  Subjects with a history of malignant ear canal tumors within 3 years of screening for
             eligibility
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear.  Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus.  Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane.  Conduction hearing loss is noted in the left ear.  The remainder of the ear, nose, and throat examination is normal.

Patient description (patient's own words): I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal.

Does the patient match the trial criteria? Contradiction