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Use of Biodesign® Otologic Graft in Tympanoplasty

Primary Purpose

Tympanic Membrane Perforation

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Biodesign Otologic graft
Autologous temporalis fascia
Sponsored by
Ascension South East Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tympanic Membrane Perforation

Eligibility Criteria

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

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.

Sites / Locations

  • Ascension Providence Hospital, Novi Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Biodesign graft tympanic membrane repair

Autograft tympanic membrane repair

Arm Description

Patient's perforated tympanic membrane will be repaired with an acellular matrix derived from porcine small intestine submucosa, Biodesign Otologic graft

Patient's perforated tympanic membrane will be repaired with autologous temporalis fascia.

Outcomes

Primary Outcome Measures

Assessment of graft take after tympanoplasty
Microscopically evaluate tympanic membrane for perforation closure
Assessment of graft take after tympanoplasty
Microscopically evaluate tympanic membrane for perforation closure
Assessment of graft take after tympanoplasty
Microscopically evaluate tympanic membrane for perforation closure
Assessment of graft take after tympanoplasty
Microscopically evaluate tympanic membrane for perforation closure

Secondary Outcome Measures

Measurement of Hearing Parameters
Test the pure tone conduction (average of 500, 1000 and 2000 Hz).
Measurement of Hearing Parameters
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.
Measurement of Hearing Parameters
Test Word Recognition for 50-2 syllables words
Measurement of Hearing Parameters
Test the pure tone conduction (average of 500, 1000 and 2000 Hz).
Measurement of Hearing Parameters
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.
Measurement of Hearing Parameters
The word recognition testing evaluates the patient's ability to repeat phonetically balanced words appropriate for his/her hearing level.
Measurement of Hearing Parameters
Test the pure tone conduction (average of 500, 1000 and 2000 Hz).
Measurement of Hearing Parameters
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.
Measurement of Hearing Parameters
The word recognition testing evaluates the patient's ability to repeat phonetically balanced words appropriate for his/her hearing level.

Full Information

First Posted
March 18, 2019
Last Updated
August 10, 2022
Sponsor
Ascension South East Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT03904316
Brief Title
Use of Biodesign® Otologic Graft in Tympanoplasty
Official Title
Use of Biodesign® Otologic Graft in Tympanoplasty: A Prospective, Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Withdrawn
Why Stopped
The trial was stopped as the benefit was challenging to determine in preliminary usage.
Study Start Date
October 3, 2018 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ascension South East Michigan

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biodesign graft tympanic membrane repair
Arm Type
Experimental
Arm Description
Patient's perforated tympanic membrane will be repaired with an acellular matrix derived from porcine small intestine submucosa, Biodesign Otologic graft
Arm Title
Autograft tympanic membrane repair
Arm Type
Active Comparator
Arm Description
Patient's perforated tympanic membrane will be repaired with autologous temporalis fascia.
Intervention Type
Biological
Intervention Name(s)
Biodesign Otologic graft
Intervention Description
Acellular matrix derived from porcine small intestine submucosa
Intervention Type
Other
Intervention Name(s)
Autologous temporalis fascia
Intervention Description
An autologous graft for tympanic membrane repair
Primary Outcome Measure Information:
Title
Assessment of graft take after tympanoplasty
Description
Microscopically evaluate tympanic membrane for perforation closure
Time Frame
1 month postoperatively by the surgeon
Title
Assessment of graft take after tympanoplasty
Description
Microscopically evaluate tympanic membrane for perforation closure
Time Frame
2 months postoperatively by the surgeon
Title
Assessment of graft take after tympanoplasty
Description
Microscopically evaluate tympanic membrane for perforation closure
Time Frame
3 months postoperatively by the surgeon
Title
Assessment of graft take after tympanoplasty
Description
Microscopically evaluate tympanic membrane for perforation closure
Time Frame
6 months postoperatively by the surgeon
Secondary Outcome Measure Information:
Title
Measurement of Hearing Parameters
Description
Test the pure tone conduction (average of 500, 1000 and 2000 Hz).
Time Frame
Measure hearing parameters preoperatively
Title
Measurement of Hearing Parameters
Description
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.
Time Frame
Measure hearing parameters preoperatively.
Title
Measurement of Hearing Parameters
Description
Test Word Recognition for 50-2 syllables words
Time Frame
Measure hearing parameters preoperatively
Title
Measurement of Hearing Parameters
Description
Test the pure tone conduction (average of 500, 1000 and 2000 Hz).
Time Frame
Measure hearing parameters 3 months postoperatively
Title
Measurement of Hearing Parameters
Description
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.
Time Frame
Measure hearing parameters 3 months postoperatively
Title
Measurement of Hearing Parameters
Description
The word recognition testing evaluates the patient's ability to repeat phonetically balanced words appropriate for his/her hearing level.
Time Frame
Measure hearing parameters 3 months postoperatively
Title
Measurement of Hearing Parameters
Description
Test the pure tone conduction (average of 500, 1000 and 2000 Hz).
Time Frame
Measure hearing parameters 6 months postoperatively
Title
Measurement of Hearing Parameters
Description
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.
Time Frame
Measure hearing parameters 6 months postoperatively
Title
Measurement of Hearing Parameters
Description
The word recognition testing evaluates the patient's ability to repeat phonetically balanced words appropriate for his/her hearing level.
Time Frame
Measure hearing parameters 6 months postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seilesh Babu, MD
Organizational Affiliation
Michigan Ear Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ascension Providence Hospital, Novi Campus
City
Novi
State/Province
Michigan
ZIP/Postal Code
48374
Country
United States

12. IPD Sharing Statement

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14623693
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Use of Biodesign® Otologic Graft in Tympanoplasty

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