Use of Biodesign® Otologic Graft in Tympanoplasty

Study Overview
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Brief Summary
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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
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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.

Official Title
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Use of Biodesign® Otologic Graft in Tympanoplasty: A Prospective, Randomized Trial

Conditions
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Tympanic Membrane Perforation

Intervention / Treatment
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* Biological: Biodesign Otologic graft
* Other: Autologous temporalis fascia


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biodesign graft tympanic membrane repair<br>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<br>* Acellular matrix derived from porcine small intestine submucosa<br>|
| Active Comparator: Autograft tympanic membrane repair<br>Patient's perforated tympanic membrane will be repaired with autologous temporalis fascia. | Other: Autologous temporalis fascia<br>* An autologous graft for tympanic membrane repair<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of graft take after tympanoplasty | Microscopically evaluate tympanic membrane for perforation closure | 1 month postoperatively by the surgeon | 
| Assessment of graft take after tympanoplasty | Microscopically evaluate tympanic membrane for perforation closure | 2 months postoperatively by the surgeon | 
| Assessment of graft take after tympanoplasty | Microscopically evaluate tympanic membrane for perforation closure | 3 months postoperatively by the surgeon | 
| Assessment of graft take after tympanoplasty | Microscopically evaluate tympanic membrane for perforation closure | 6 months postoperatively by the surgeon | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of Hearing Parameters | Test the pure tone conduction (average of 500, 1000 and 2000 Hz). | Measure hearing parameters preoperatively | 
| Measurement of Hearing Parameters | 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. | Measure hearing parameters preoperatively. | 
| Measurement of Hearing Parameters | Test Word Recognition for 50-2 syllables words | Measure hearing parameters preoperatively | 
| Measurement of Hearing Parameters | Test the pure tone conduction (average of 500, 1000 and 2000 Hz). | Measure hearing parameters 3 months postoperatively | 
| Measurement of Hearing Parameters | 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. | Measure hearing parameters 3 months postoperatively | 
| Measurement of Hearing Parameters | The word recognition testing evaluates the patient's ability to repeat phonetically balanced words appropriate for his/her hearing level. | Measure hearing parameters 3 months postoperatively | 
| Measurement of Hearing Parameters | Test the pure tone conduction (average of 500, 1000 and 2000 Hz). | Measure hearing parameters 6 months postoperatively | 
| Measurement of Hearing Parameters | 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. | Measure hearing parameters 6 months postoperatively | 
| Measurement of Hearing Parameters | The word recognition testing evaluates the patient's ability to repeat phonetically balanced words appropriate for his/her hearing level. | Measure hearing parameters 6 months postoperatively |