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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03028272
Recruitment Status : Withdrawn (Lack of qualified participants)
First Posted : January 23, 2017
Last Update Posted : April 15, 2021
Information provided by (Responsible Party):
Arnaldo L. Rivera, University of Missouri-Columbia

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.

Condition or disease Intervention/treatment Phase
Tympanic Membrane Perforation Other: Skye Barrier Other: Fascia Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Participant will be blinded to the type of barrier received.
Primary Purpose: Treatment
Official Title: Hearing Results and Post Surgical Outcomes Using Amniotic Membrane Allograft Versus Fascia for Tympanoplasty: A Randomized Prospective Trial
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : December 31, 2020
Actual Study Completion Date : December 31, 2020

Arm Intervention/treatment
Active Comparator: Fascia
Autologous donor substrate
Other: Fascia
Autologous donor substrate. Examples include tragal cartilage, perichondrium, temporalis fascia, and temporoparietal fascia

Experimental: Skye Barrier
Amniotic membrane allograft
Other: Skye Barrier
Substrate derived from amniotic tissue that is FDA-approved for human implantation

Primary Outcome Measures :
  1. Comparable or improved performance of Skye ActiveBarrier [ Time Frame: 12-18 months ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03028272

Sponsors and Collaborators
University of Missouri-Columbia
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Principal Investigator: Arnaldo Rivera, M.D. University of Missouri-Columbia
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Responsible Party: Arnaldo L. Rivera, Associate Professor, University of Missouri-Columbia Identifier: NCT03028272    
Other Study ID Numbers: 2006074
First Posted: January 23, 2017    Key Record Dates
Last Update Posted: April 15, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The investigators do not intend to share individual participant data to other researchers. Analyzed data will be published in peer-review journal.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Arnaldo L. Rivera, University of Missouri-Columbia:
tympanic membrane perforation
Additional relevant MeSH terms:
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Tympanic Membrane Perforation
Ear Diseases
Otorhinolaryngologic Diseases
Wounds and Injuries