Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Use of Biodesign® Otologic Graft in Tympanoplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03904316
Recruitment Status : Recruiting
First Posted : April 5, 2019
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Ascension South East Michigan

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.

Condition or disease Intervention/treatment Phase
Tympanic Membrane Perforation Biological: Biodesign Otologic graft Other: Autologous temporalis fascia Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Biodesign® Otologic Graft in Tympanoplasty: A Prospective, Randomized Trial
Actual Study Start Date : October 3, 2018
Estimated Primary Completion Date : October 3, 2019
Estimated Study Completion Date : October 3, 2019

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




Primary Outcome Measures :
  1. Assessment of graft take after tympanoplasty [ Time Frame: 1 month postoperatively by the surgeon ]
    Microscopically evaluate tympanic membrane for perforation closure

  2. Assessment of graft take after tympanoplasty [ Time Frame: 2 months postoperatively by the surgeon ]
    Microscopically evaluate tympanic membrane for perforation closure

  3. Assessment of graft take after tympanoplasty [ Time Frame: 3 months postoperatively by the surgeon ]
    Microscopically evaluate tympanic membrane for perforation closure

  4. Assessment of graft take after tympanoplasty [ Time Frame: 6 months postoperatively by the surgeon ]
    Microscopically evaluate tympanic membrane for perforation closure


Secondary Outcome Measures :
  1. Measurement of Hearing Parameters [ Time Frame: Measure hearing parameters preoperatively ]
    Test the pure tone conduction (average of 500, 1000 and 2000 Hz).

  2. 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.

  3. Measurement of Hearing Parameters [ Time Frame: Measure hearing parameters preoperatively ]
    Test Word Recognition for 50-2 syllables words

  4. Measurement of Hearing Parameters [ Time Frame: Measure hearing parameters 3 months postoperatively ]
    Test the pure tone conduction (average of 500, 1000 and 2000 Hz).

  5. 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.

  6. 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.

  7. Measurement of Hearing Parameters [ Time Frame: Measure hearing parameters 6 months postoperatively ]
    Test the pure tone conduction (average of 500, 1000 and 2000 Hz).

  8. 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.

  9. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 tympanoplasty without mastoidectomy.

Exclusion Criteria:

  • Patients with a known biologic sensitivity or a cultural objection to 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): NCT03904316


Contacts
Layout table for location contacts
Contact: Seilesh Babu, MD (248) 865-4444 sbabu@gmail.com
Contact: Marianne Lahey, BSN (248)4654828 Marianne.Lahey@ascension.org

Locations
Layout table for location information
United States, Michigan
Ascension Providence Hospital, Novi Campus Recruiting
Novi, Michigan, United States, 48374
Contact: Seilish Babu, MD    248-865-4444    sbabu@gmail.com   
Contact: Marianne Lahey, BSN    (248) 465-4828    Marianne.Lahey@ascension.org   
Sponsors and Collaborators
Ascension South East Michigan
Investigators
Layout table for investigator information
Principal Investigator: Seilesh Babu, MD Michigan Ear Institute

Publications:

Layout table for additonal information
Responsible Party: Ascension South East Michigan
ClinicalTrials.gov Identifier: NCT03904316     History of Changes
Other Study ID Numbers: 1322227
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019

Layout table for additional information
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:
Layout table for MeSH terms
Tympanic Membrane Perforation
Ear Diseases
Otorhinolaryngologic Diseases
Wounds and Injuries