Hearing Results and Post Surgical Outcomes Using Amniotic Membrane Allograft vs. Fascia for Tympanoplasty

Study Overview
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Brief Summary
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The trial seeks to provide evidence that the Skye ActiveBarrier provides similar surgical and functional outcomes as fascia when used for tympanoplasties while offering benefits including reduced operative time, better patient satisfaction, and fewer complications.

Detailed Description
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A prospective randomized controlled trial will be conducted. Eligible patients will be identified, recruited and randomized to receive either repair using the standard fascia graft or repair using the Skye ActiveBarrier. Subjects will undergo a preoperative evaluation followed by TM repair and subsequent regular office visits to assess functional outcomes, complications, and satisfaction. Patients will be blinded to the substrate used for their repair. As there are two different approaches for a tympanoplasty (through the ear canal or incision behind the ear) based on the subject's ear anatomy and location of the perforation, a sham surgery will not be necessary to disguise which graft is received. At follow up visits, photos may be taken of patients' TMs and these photos will be evaluated for healing by an otologist who did not conduct the surgery in a blinded fashion. At the 1 year follow up appointment, subjects will be told which substrate they received and at the study's conclusion subjects will notified about the study's findings.

Official Title
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Hearing Results and Post Surgical Outcomes Using Amniotic Membrane Allograft Versus Fascia for Tympanoplasty: A Randomized Prospective Trial

Conditions
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Tympanic Membrane Perforation

Intervention / Treatment
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* Other: Skye Barrier
* Other: Fascia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of a tympanic membrane perforation Patient at PI's clinic Exclusion Criteria: Presence of cholesteatoma Prior surgery on the same-sided TM or middle ear Ossicular chain abnormalities Congenital deformities involving the middle ear or eustachian tube Refusal to undergo surgery

Ages Eligible for Study
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Minimum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fascia<br>Autologous donor substrate | Other: Fascia<br>* Autologous donor substrate. Examples include tragal cartilage, perichondrium, temporalis fascia, and temporoparietal fascia<br>|
| Experimental: Skye Barrier<br>Amniotic membrane allograft | Other: Skye Barrier<br>* Substrate derived from amniotic tissue that is FDA-approved for human implantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparable or improved performance of Skye ActiveBarrier | Comparable or improved performance will be assessed by combining data from 6 specific measurements: air and bone gap audiogram, word recognition score via audiogram, number of surgical/post-surgical complications, operating time and healing time. | 12-18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tympanic membrane perforation