Tympanic Membrane Perforation
Conditions
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.
Interventions
BIOLOGICALBiodesign Otologic graft
Acellular matrix derived from porcine small intestine submucosa
OTHERAutologous temporalis fascia
An autologous graft for tympanic membrane repair
Sponsors
Henry Ford Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of graft take after tympanoplasty | 1 month postoperatively by the surgeon | Microscopically evaluate tympanic membrane for perforation closure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of Hearing Parameters | Measure hearing parameters preoperatively | Test the pure tone conduction (average of 500, 1000 and 2000 Hz). |
Countries
United States
Outcome results
None listed