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

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ClinicalTrials.gov Identifier: NCT03902938
Recruitment Status : Recruiting
First Posted : April 4, 2019
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Ascension South East Michigan

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.

Condition or disease Intervention/treatment Phase
Otologic Disease Biological: Biodesign Otologic graft Other: Autograft temporalis fascia Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Biodesign® Otologic Graft in Canal Wall Down Mastoidectomy: A Prospective, Randomized Trial
Actual Study Start Date : October 2, 2018
Estimated Primary Completion Date : October 2, 2019
Estimated Study Completion Date : October 2, 2019

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 Name: 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.




Primary Outcome Measures :
  1. Epithelialization of the canal wall down mastoid cavity [ Time Frame: Evaluation at 1 month post-operatively. ]
    Direct observation by surgeon

  2. Epithelialization of the canal wall down mastoid cavity [ Time Frame: Evaluation at 2 months post-operatively. ]
    Direct observation by surgeon

  3. Epithelialization of the canal wall down mastoid cavity [ Time Frame: Evaluation at 3 months post-operatively. ]
    Direct observation by surgeon

  4. Epithelialization of the canal wall down mastoid cavity [ Time Frame: Evaluation at 6 months post-operatively. ]
    Direct observation by surgeon


Secondary Outcome Measures :
  1. Determination of dry cavity [ Time Frame: Evaluation at 1 month post-operatively ]
    Direct observation by surgeon

  2. Determination of dry cavity [ Time Frame: Evaluation at 2 months post-operatively ]
    Direct observation by surgeon

  3. Determination of dry cavity [ Time Frame: Evaluation at 3 months post-operatively ]
    Direct observation by surgeon

  4. Determination of dry cavity [ Time Frame: Evaluation at 6 months post-operatively ]
    Direct observation by surgeon

  5. Audio-metric outcome [ Time Frame: Evaluation at 3 months post-operatively ]
    Test the pure tone air conduction (average of 500, 1000 and 2000 Hz)

  6. 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.

  7. 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.

  8. Audio-metric outcome [ Time Frame: Evaluation at 6 months post-operatively ]
    Test the pure tone air conduction (average of 500, 1000 and 2000 Hz)

  9. 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.

  10. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03902938


Contacts
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Contact: Seilesh Babu, MD (248) 865-4444 sbabu@gmail.com
Contact: Marianne Lahey, BSN (248) 465-4828

Locations
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United States, Michigan
Ascension Providence Hospital, Novi Campus Recruiting
Novi, Michigan, United States, 48374
Principal Investigator: Seilish Babu, MD         
Sponsors and Collaborators
Ascension South East Michigan
Investigators
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Principal Investigator: Seilesh Babu, MD Physician of record

Publications:

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Responsible Party: Ascension South East Michigan
ClinicalTrials.gov Identifier: NCT03902938     History of Changes
Other Study ID Numbers: 1322212
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019

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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
Additional relevant MeSH terms:
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Ear Diseases
Otorhinolaryngologic Diseases