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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2020-12-31

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.

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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.

Conditions

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Tympanic Membrane Perforation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Participant will be blinded to the type of barrier received.

Study Groups

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Fascia

Autologous donor substrate

Group Type ACTIVE_COMPARATOR

Fascia

Intervention Type OTHER

Autologous donor substrate. Examples include tragal cartilage, perichondrium, temporalis fascia, and temporoparietal fascia

Skye Barrier

Amniotic membrane allograft

Group Type EXPERIMENTAL

Skye Barrier

Intervention Type OTHER

Substrate derived from amniotic tissue that is FDA-approved for human implantation

Interventions

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Skye Barrier

Substrate derived from amniotic tissue that is FDA-approved for human implantation

Intervention Type OTHER

Fascia

Autologous donor substrate. Examples include tragal cartilage, perichondrium, temporalis fascia, and temporoparietal fascia

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Presence of a tympanic membrane perforation
2. Patient at PI's clinic

Exclusion Criteria

1. Presence of cholesteatoma
2. Prior surgery on the same-sided TM or middle ear
3. Ossicular chain abnormalities
4. Congenital deformities involving the middle ear or eustachian tube
5. Refusal to undergo surgery

Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No