Use of Biodesign® Otologic Graft in Tympanoplasty
Phase 4
Withdrawn
- Conditions
- Tympanic Membrane Perforation
- Registration Number
- NCT03904316
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Assessment of graft take after tympanoplasty 6 months postoperatively by the surgeon Microscopically evaluate tympanic membrane for perforation closure
- Secondary Outcome Measures
Name Time Method Measurement of Hearing Parameters 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.
Trial Locations
- Locations (1)
Ascension Providence Hospital, Novi Campus
🇺🇸Novi, Michigan, United States
Ascension Providence Hospital, Novi Campus🇺🇸Novi, Michigan, United States