Use of Biodesign® Otologic Graft in Tympanoplasty

August 10, 2022 updated by: Ascension South East Michigan

Use of Biodesign® Otologic Graft in Tympanoplasty: A Prospective, Randomized Trial

This is a prospective, randomized trial to evaluate tympanoplasty outcomes using Biodesign SIS graft compared to autologous temporalis fascia, the most commonly used graft for repair of tympanic membrane.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Patients 18 years or older will undergo primary tympanoplasty without mastoidectomy. The patients will be randomized into groups receiving Biodesign versus autograft temporalis fascia for repair.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Novi, Michigan, United States, 48374
        • Ascension Providence Hospital, Novi Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing primary tympanoplasty without mastoidectomy.

Exclusion Criteria:

  • Patients with a known biologic sensitivity or a cultural objection to use of porcine materials.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Biodesign graft tympanic membrane repair
Patient's perforated tympanic membrane will be repaired with an acellular matrix derived from porcine small intestine submucosa, Biodesign Otologic graft
Biological: Biodesign Otologic graft
Acellular matrix derived from porcine small intestine submucosa
Active Comparator: Autograft tympanic membrane repair
Patient's perforated tympanic membrane will be repaired with autologous temporalis fascia.
Other: Autologous temporalis fascia
An autologous graft for tympanic membrane repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of graft take after tympanoplasty
Time Frame: 1 month postoperatively by the surgeon
Microscopically evaluate tympanic membrane for perforation closure
1 month postoperatively by the surgeon
Assessment of graft take after tympanoplasty
Time Frame: 2 months postoperatively by the surgeon
Microscopically evaluate tympanic membrane for perforation closure
2 months postoperatively by the surgeon
Assessment of graft take after tympanoplasty
Time Frame: 3 months postoperatively by the surgeon
Microscopically evaluate tympanic membrane for perforation closure
3 months postoperatively by the surgeon
Assessment of graft take after tympanoplasty
Time Frame: 6 months postoperatively by the surgeon
Microscopically evaluate tympanic membrane for perforation closure
6 months postoperatively by the surgeon

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of Hearing Parameters
Time Frame: Measure hearing parameters preoperatively
Test the pure tone conduction (average of 500, 1000 and 2000 Hz).
Measure hearing parameters preoperatively
Measurement of Hearing Parameters
Time Frame: Measure hearing parameters preoperatively.
Test the Air Bone Gap starting at 1000 Hz then 2000, 4000, 8000, 250 and 500 for air-conduction thresholds. Then test non-masked bone-conduction thresholds at the same frequencies.
Measure hearing parameters preoperatively.
Measurement of Hearing Parameters
Time Frame: Measure hearing parameters preoperatively
Test Word Recognition for 50-2 syllables words
Measure hearing parameters preoperatively
Measurement of Hearing Parameters
Time Frame: Measure hearing parameters 3 months postoperatively
Test the pure tone conduction (average of 500, 1000 and 2000 Hz).
Measure hearing parameters 3 months postoperatively
Measurement of Hearing Parameters
Time Frame: Measure hearing parameters 3 months postoperatively
Determine the air bond gap by measuring the difference between the air conduction and gone conduction testing. The air bone gap is the difference between the 2 readings and must be present at 3 consecutive frequencies.
Measure hearing parameters 3 months postoperatively
Measurement of Hearing Parameters
Time Frame: Measure hearing parameters 3 months postoperatively
The word recognition testing evaluates the patient's ability to repeat phonetically balanced words appropriate for his/her hearing level.
Measure hearing parameters 3 months postoperatively
Measurement of Hearing Parameters
Time Frame: Measure hearing parameters 6 months postoperatively
Test the pure tone conduction (average of 500, 1000 and 2000 Hz).
Measure hearing parameters 6 months postoperatively
Measurement of Hearing Parameters
Time Frame: Measure hearing parameters 6 months postoperatively
Determine the air bond gap by measuring the difference between the air conduction and gone conduction testing. The air bone gap is the difference between the 2 readings and must be present at 3 consecutive frequencies.
Measure hearing parameters 6 months postoperatively
Measurement of Hearing Parameters
Time Frame: Measure hearing parameters 6 months postoperatively
The word recognition testing evaluates the patient's ability to repeat phonetically balanced words appropriate for his/her hearing level.
Measure hearing parameters 6 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ascension South East Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2018

Primary Completion (Actual)

July 1, 2022

Study Completion (Actual)

July 1, 2022

Study Registration Dates

First Submitted

March 18, 2019

First Submitted That Met QC Criteria

April 3, 2019

First Posted (Actual)

April 5, 2019

Study Record Updates

Last Update Posted (Actual)

August 12, 2022

Last Update Submitted That Met QC Criteria

August 10, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1322227

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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