Trials / Withdrawn
WithdrawnNCT03904316
Use of Biodesign® Otologic Graft in Tympanoplasty
Use of Biodesign® Otologic Graft in Tympanoplasty: A Prospective, Randomized Trial
- Status
- Withdrawn
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Henry Ford Health System · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Biodesign Otologic graft | Acellular matrix derived from porcine small intestine submucosa |
| OTHER | Autologous temporalis fascia | An autologous graft for tympanic membrane repair |
Timeline
- Start date
- 2018-10-03
- Primary completion
- 2022-07-01
- Completion
- 2022-07-01
- First posted
- 2019-04-05
- Last updated
- 2025-12-19
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03904316. Inclusion in this directory is not an endorsement.