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

August 10, 2022 updated by: Ascension South East Michigan
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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 Otologic Graft
Graft following canal wall down mastoidectomy.
Biological: Biodesign Otologic graft
Patient's mastoid cavity will be covered with porcine small intestine submucosa, Biodesign.
Other Names:
  • Porcine small intestine submucosa
Active Comparator: Autograft temporalis fascia
Graft following canal wall down mastoidectomy.
Other: Autograft temporalis fascia
Patient's mastoid cavity will be covered with covered with autograft.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epithelialization of the canal wall down mastoid cavity
Time Frame: Evaluation at 1 month post-operatively.
Direct observation by surgeon
Evaluation at 1 month post-operatively.
Epithelialization of the canal wall down mastoid cavity
Time Frame: Evaluation at 2 months post-operatively.
Direct observation by surgeon
Evaluation at 2 months post-operatively.
Epithelialization of the canal wall down mastoid cavity
Time Frame: Evaluation at 3 months post-operatively.
Direct observation by surgeon
Evaluation at 3 months post-operatively.
Epithelialization of the canal wall down mastoid cavity
Time Frame: Evaluation at 6 months post-operatively.
Direct observation by surgeon
Evaluation at 6 months post-operatively.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determination of dry cavity
Time Frame: Evaluation at 1 month post-operatively
Direct observation by surgeon
Evaluation at 1 month post-operatively
Determination of dry cavity
Time Frame: Evaluation at 2 months post-operatively
Direct observation by surgeon
Evaluation at 2 months post-operatively
Determination of dry cavity
Time Frame: Evaluation at 3 months post-operatively
Direct observation by surgeon
Evaluation at 3 months post-operatively
Determination of dry cavity
Time Frame: Evaluation at 6 months post-operatively
Direct observation by surgeon
Evaluation at 6 months post-operatively
Audio-metric outcome
Time Frame: Evaluation at 3 months post-operatively
Test the pure tone air conduction (average of 500, 1000 and 2000 Hz)
Evaluation at 3 months post-operatively
Audio-metric outcome
Time Frame: Evaluation at 3 months post-operatively
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.
Evaluation at 3 months post-operatively
Audio-metric outcome
Time Frame: Evaluation at 3 months post-operatively
The word recognition testing evaluates the patient's ability to repeat phonetically balanced words appropriate for their hearing level.
Evaluation at 3 months post-operatively
Audio-metric outcome
Time Frame: Evaluation at 6 months post-operatively
Test the pure tone air conduction (average of 500, 1000 and 2000 Hz)
Evaluation at 6 months post-operatively
Audio-metric outcome
Time Frame: Evaluation at 6 months post-operatively
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.
Evaluation at 6 months post-operatively
Audio-metric outcome
Time Frame: Evaluation at 6 months post-operatively
The word recognition testing evaluates the patient's ability to repeat phonetically balanced words appropriate for their hearing level.
Evaluation at 6 months post-operatively

Collaborators and Investigators

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

Sponsor

Ascension South East Michigan

Investigators

  • Principal Investigator: Seilesh Babu, MD, Physician of Record

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 2, 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 2, 2019

First Posted (Actual)

April 4, 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

  • 1322212

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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