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Use of Biodesign® Otologic Graft in Canal Wall Down Mastoidectomy: A Prospective, Randomized Trial

Primary Purpose

Otologic Disease

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Biodesign Otologic graft
Autograft 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 Otologic Disease

Eligibility Criteria

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

Inclusion Criteria:

  • Patients undergoing primary canal wall mastoidectomy

Exclusion Criteria:

  • Patients with a known biologic sensitivity or a cultural aversion to the 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 Otologic Graft

Autograft temporalis fascia

Arm Description

Graft following canal wall down mastoidectomy.

Graft following canal wall down mastoidectomy.

Outcomes

Primary Outcome Measures

Epithelialization of the canal wall down mastoid cavity
Direct observation by surgeon
Epithelialization of the canal wall down mastoid cavity
Direct observation by surgeon
Epithelialization of the canal wall down mastoid cavity
Direct observation by surgeon
Epithelialization of the canal wall down mastoid cavity
Direct observation by surgeon

Secondary Outcome Measures

Determination of dry cavity
Direct observation by surgeon
Determination of dry cavity
Direct observation by surgeon
Determination of dry cavity
Direct observation by surgeon
Determination of dry cavity
Direct observation by surgeon
Audio-metric outcome
Test the pure tone air conduction (average of 500, 1000 and 2000 Hz)
Audio-metric outcome
Determine the Air Bone Gap by measuring the difference between the air conduction and bone conduction testing. The air bone gap is the difference between the 2 readings and must be present at 3 consecutive frequencies.
Audio-metric outcome
The word recognition testing evaluates the patient's ability to repeat phonetically balanced words appropriate for their hearing level.
Audio-metric outcome
Test the pure tone air conduction (average of 500, 1000 and 2000 Hz)
Audio-metric outcome
Determine the Air Bone Gap by measuring the difference between the air conduction and bone conduction testing. The air bone gap is the difference between the 2 readings and must be present at 3 consecutive frequencies.
Audio-metric outcome
The word recognition testing evaluates the patient's ability to repeat phonetically balanced words appropriate for their 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
NCT03902938
Brief Title
Use of Biodesign® Otologic Graft in Canal Wall Down Mastoidectomy: A Prospective, Randomized Trial
Official Title
Use of Biodesign® Otologic Graft in Canal Wall Down Mastoidectomy: 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 the preliminary usage.
Study Start Date
October 2, 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 canal wall down mastoidectomy (CWDM) healing outcomes using Biodesign® small intestine submucosa graft compared to autologous temporalis fascia graft.
Detailed Description
Patients 18 or older will undergo primary canal wall down mastoidectomy. Patients with known biologic sensitivity or cultural objection to use of porcine materials will be excluded. Data will be derived from the medical record and surgeon reports as detailed on pre-op and follow-up forms. Variables collected include age, gender, medical co-morbidities, body mass index, pre-operative audiometric values (including word recognition score, pure tone average, and air bone gap), side of surgery, size of operative cavity, infectious state (draining versus dry), exact surgical procedure, presence of cholesteatoma, time to dry cavity, time to complete epithelialization (as observed directly by the surgeon), and post-operative complications (such as persistent perforation, drainage, granulation tissue formation, and facial nerve outcomes). Dates and patient number will be recorded. Patients will be randomly assigned using randomization software, whereby patients will be assigned a sequential research number that is pre-randomized to one research arm. The study cannot be blinded, as the surgeon will be able to identify which graft will be used. De-identified photographs of the post-operative outcomes at each time point will be recorded photographically. Three physicians will review these photographs without prior knowledge of the treatment arm.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otologic Disease

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 Otologic Graft
Arm Type
Experimental
Arm Description
Graft following canal wall down mastoidectomy.
Arm Title
Autograft temporalis fascia
Arm Type
Active Comparator
Arm Description
Graft following canal wall down mastoidectomy.
Intervention Type
Biological
Intervention Name(s)
Biodesign Otologic graft
Other Intervention Name(s)
Porcine small intestine submucosa
Intervention Description
Patient's mastoid cavity will be covered with porcine small intestine submucosa, Biodesign.
Intervention Type
Other
Intervention Name(s)
Autograft temporalis fascia
Intervention Description
Patient's mastoid cavity will be covered with covered with autograft.
Primary Outcome Measure Information:
Title
Epithelialization of the canal wall down mastoid cavity
Description
Direct observation by surgeon
Time Frame
Evaluation at 1 month post-operatively.
Title
Epithelialization of the canal wall down mastoid cavity
Description
Direct observation by surgeon
Time Frame
Evaluation at 2 months post-operatively.
Title
Epithelialization of the canal wall down mastoid cavity
Description
Direct observation by surgeon
Time Frame
Evaluation at 3 months post-operatively.
Title
Epithelialization of the canal wall down mastoid cavity
Description
Direct observation by surgeon
Time Frame
Evaluation at 6 months post-operatively.
Secondary Outcome Measure Information:
Title
Determination of dry cavity
Description
Direct observation by surgeon
Time Frame
Evaluation at 1 month post-operatively
Title
Determination of dry cavity
Description
Direct observation by surgeon
Time Frame
Evaluation at 2 months post-operatively
Title
Determination of dry cavity
Description
Direct observation by surgeon
Time Frame
Evaluation at 3 months post-operatively
Title
Determination of dry cavity
Description
Direct observation by surgeon
Time Frame
Evaluation at 6 months post-operatively
Title
Audio-metric outcome
Description
Test the pure tone air conduction (average of 500, 1000 and 2000 Hz)
Time Frame
Evaluation at 3 months post-operatively
Title
Audio-metric outcome
Description
Determine the Air Bone Gap by measuring the difference between the air conduction and bone conduction testing. The air bone gap is the difference between the 2 readings and must be present at 3 consecutive frequencies.
Time Frame
Evaluation at 3 months post-operatively
Title
Audio-metric outcome
Description
The word recognition testing evaluates the patient's ability to repeat phonetically balanced words appropriate for their hearing level.
Time Frame
Evaluation at 3 months post-operatively
Title
Audio-metric outcome
Description
Test the pure tone air conduction (average of 500, 1000 and 2000 Hz)
Time Frame
Evaluation at 6 months post-operatively
Title
Audio-metric outcome
Description
Determine the Air Bone Gap by measuring the difference between the air conduction and bone conduction testing. The air bone gap is the difference between the 2 readings and must be present at 3 consecutive frequencies.
Time Frame
Evaluation at 6 months post-operatively
Title
Audio-metric outcome
Description
The word recognition testing evaluates the patient's ability to repeat phonetically balanced words appropriate for their hearing level.
Time Frame
Evaluation at 6 months post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing primary canal wall mastoidectomy Exclusion Criteria: Patients with a known biologic sensitivity or a cultural aversion to the use of porcine materials.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seilesh Babu, MD
Organizational Affiliation
Physician of record
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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Use of Biodesign® Otologic Graft in Canal Wall Down Mastoidectomy: A Prospective, Randomized Trial

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