Clinical trial NCT03904316: Use of Biodesign® Otologic Graft in Tympanoplasty
Official title: Use of Biodesign® Otologic Graft in Tympanoplasty: A Prospective, Randomized Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Tympanic Membrane Perforation
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2019-04-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Assessment of graft take after tympanoplasty
timeFrame: 1 month postoperatively by the surgeon
measure: Assessment of graft take after tympanoplasty
timeFrame: 2 months postoperatively by the surgeon
measure: Assessment of graft take after tympanoplasty
timeFrame: 3 months postoperatively by the surgeon
measure: Assessment of graft take after tympanoplasty
timeFrame: 6 months postoperatively by the surgeon
Secondary outcomes:
measure: Measurement of Hearing Parameters
timeFrame: Measure hearing parameters preoperatively
measure: Measurement of Hearing Parameters
timeFrame: Measure hearing parameters preoperatively.
measure: Measurement of Hearing Parameters
timeFrame: Measure hearing parameters preoperatively
measure: Measurement of Hearing Parameters
timeFrame: Measure hearing parameters 3 months postoperatively
measure: Measurement of Hearing Parameters
timeFrame: Measure hearing parameters 3 months postoperatively
measure: Measurement of Hearing Parameters
timeFrame: Measure hearing parameters 3 months postoperatively
measure: Measurement of Hearing Parameters
timeFrame: Measure hearing parameters 6 months postoperatively
measure: Measurement of Hearing Parameters
timeFrame: Measure hearing parameters 6 months postoperatively
measure: Measurement of Hearing Parameters
timeFrame: Measure hearing parameters 6 months postoperatively
Other outcomes:
Locations:
city: Novi
country: United States
facility: Ascension Providence Hospital, Novi Campus
state: Michigan
Study officials:
affiliation: Michigan Ear Institute
name: Seilesh Babu, MD
role: PRINCIPAL_INVESTIGATOR
References:
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