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

Primary Purpose

Tympanic Membrane Perforation

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Skye Barrier

Fascia

About this trial

This is an interventional treatment trial for Tympanic Membrane Perforation focused on measuring tympanic membrane perforation

Eligibility Criteria

3 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Fascia

Skye Barrier

Arm Description

Autologous donor substrate

Amniotic membrane allograft

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03028272

First Posted

January 18, 2017

Last Updated

April 12, 2021

Sponsor

University of Missouri-Columbia

1. Study Identification

Unique Protocol Identification Number

NCT03028272

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Withdrawn

Why Stopped

Lack of qualified participants

Study Start Date

January 1, 2017 (Actual)

Primary Completion Date

December 31, 2020 (Actual)

Study Completion Date

December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Missouri-Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tympanic Membrane Perforation

Keywords

tympanic membrane perforation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Masking Description

Participant will be blinded to the type of barrier received.

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fascia

Arm Type

Active Comparator

Arm Description

Autologous donor substrate

Arm Title

Skye Barrier

Arm Type

Experimental

Arm Description

Amniotic membrane allograft

Intervention Type

Other

Intervention Name(s)

Skye Barrier

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Fascia

Intervention Description

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

Primary Outcome Measure Information:

Title

Comparable or improved performance of Skye ActiveBarrier

Description

Time Frame

12-18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Arnaldo Rivera, M.D.

Organizational Affiliation

University of Missouri-Columbia

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

The investigators do not intend to share individual participant data to other researchers. Analyzed data will be published in peer-review journal.

Learn more about this trial

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

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