Overview
The purpose of the study is to assess the effectiveness of Perf-Fix as a gel patch to aid in the natural healing process to close chronic, >25% tympanic membrane perforation.
Eligibility
Inclusion Criteria:
- Willing and able to provide informed consent, legally authorized representative (LAR) consent, or LAR consent and assent when age appropriate
- Females and males at least 5 years old
- Perforation involves >25% of the tympanic membrane
- Perforation has not spontaneously closed after 4 weeks of watchful waiting
- Perforation is not actively healing
- Perforation can be visualized by an endoscope or microscope
- Ear wax does not occlude the perforation
Exclusion Criteria:
- Perforation is marginal (a perforation that has an area with no tympanic membrane between the perforation and the bony canal)
- Active otitis media, with or without effusion
- Otorrhea from the middle ear for more than 3 months
- History of cleft palate
- Receiving radiation therapy or taking corticosteroids, immunosuppressive agents, or chemotherapy
- Currently taking systemic antibiotics, antibiotic ear drops, and/or steroid ear drops
- Current bacterial or viral infection
- Fever (Temperature >100°F) at time of index procedure
- Diagnosed with cholesteatoma mass in the tympanic cavity
- Known history of malignant ear canal tumors within 3 years of screening for eligibility
- Abrasions/lacerations to the external auditory canal
- Significant medical condition that could prevent full participation in the procedures required for the study
- Investigator feels the subject will be unable to cooperate with the application procedure
- Parent/LAR feels the subject will be unable to cooperate with the application procedure
- Allergy to shellfish
- Known to be or could be pregnant
- Adults lacking capacity to consent