Fibroblast Growth Factor Regeneration of Tympanic Membrane Perforations
Condition: Tympanic Membrane Perforation
MeSH terms: Tympanic Membrane Perforation
Intervention: FGF-2; Placebo
Intervention description: The FGF-2 method of use comprises a pledget of gelatin foam with human fibroblast growth factor-2 (FGF-2) added to the pledget just before topical application to the tympanic membrane, and the use of Tisseel, a fibrin glue used for applications in ear surgery.; Placebo comparator using a sterile saline solution.
Intervention MeSH terms: Mitogens
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 57.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: tympanic membrane perforation; ear drum; hole

Summary:

      A Phase II randomized trial will be initiated to evaluate closure of the perforated tympanic
      membrane as the primary measureable outcome. The goal is to determine the safety and efficacy
      of Fibroblast Growth Factor-2 (FGF-2) in the closure of chronic tympanic membrane
      perforations (TMP). If FGF-2 is topically applied for the treatment of chronic TMP in humans,
      it is hypothesized it will be safe, tolerable and effective for use as treatment for tympanic
      membrane perforation. A total of 60 subjects will be recruited.
    

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