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

Tympanic Membrane Perforation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03028272
• Other study ID #: 2006074
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2021
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tympanic Membrane Perforation

Intervention

Other:
• Skye Barrier
Substrate derived from amniotic tissue that is FDA-approved for human implantation
• Fascia
Autologous donor substrate. Examples include tragal cartilage, perichondrium, temporalis fascia, and temporoparietal fascia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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