Fibroblast Growth Factor Regeneration of Tympanic Membrane Perforations
NCT ID: NCT02307916
Last Updated: 2020-12-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
57 participants
INTERVENTIONAL
2016-10-31
2020-03-31
Brief Summary
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Detailed Description
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Application of the study treatment may occur at the initial Screening Visit (pending all eligibility requirements can be confirmed) or at Visit 1 and may be repeated at each follow up visit as needed for a maximum of three treatments per treatment arm. These follow up visits will occur three weeks (+/- 7 days) from the last treatment application. During these visits, the subject's tympanic membrane will be examined, photographed, and additional otologic tests will be performed. If the perforation is found to be closed during these visits, then the subject will report in 2 months (+/-7 days) for a final study visit.
If the subject's TMP has not closed after the third and final application of their assigned treatment group, then the subject will be crossed over to the other treatment group. Again, the subject may be given up to three additional treatments in this new group. The follow up visits will follow the same schedule, occurring three weeks (+/- 7 days) from the last treatment. The same otologic procedures will be performed as in the previous visits.
All subjects will report for a final study visit 2 months (+/- 7 days) after their last follow up visit when the perforation is determined to be closed or when the subject has completed the maximum number of study visits without perforation closure. The study will be completed for reporting purposes after all subjects have completed the 2 month (+/- 7 days) follow up final visit.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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FGF-2
FGF-2 given a minimum of 1 and maximum of 3 times within, approximately, 60 days.
FGF-2
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
Equal concentration of saline is given a minimum of 1 and maximum of 3 times within, approximately, 60 days.
Placebo
Placebo comparator using a sterile saline solution.
Interventions
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FGF-2
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
Placebo comparator using a sterile saline solution.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
* 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
18 Years
ALL
No
Sponsors
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United States Department of Defense
FED
Dr. Bradley Welling
OTHER
Responsible Party
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Dr. Bradley Welling
Principal Investigator, M.D., Ph.D.
Principal Investigators
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D. B. Welling, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
Massachusetts Eye and Ear
Locations
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Massachusetts Eye and Ear
Boston, Massachusetts, United States
Wilford Hall, Lackland Airforce Base
Lackland Air Force Base, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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16-043
Identifier Type: -
Identifier Source: org_study_id