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

NCT03028272 | Withdrawn

• 1 other identifier: 2006074
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tympanic Membrane Perforation

Keywords

tympanic membrane perforation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Fascia

ACTIVE COMPARATOR

Autologous donor substrate

Other: Fascia

Skye Barrier

EXPERIMENTAL

Amniotic membrane allograft

Other: Skye Barrier

Interventions

Skye Barrier OTHER

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

Skye Barrier

Fascia OTHER

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

Fascia

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of a tympanic membrane perforation
• Patient at PI's clinic

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

MeSH Terms

Conditions

Tympanic Membrane Perforation

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Wounds and Injuries

Study Officials

• Arnaldo Rivera, M.D.

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant will be blinded to the type of barrier received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 18, 2017
• First Posted: January 23, 2017
• Study Start: January 1, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: April 15, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share