Use of Biodesign® Otologic Graft in Canal Wall Down Mastoidectomy: A Prospective, Randomized Trial

Study Overview
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Brief Summary
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This is a prospective, randomized trial to evaluate canal wall down mastoidectomy (CWDM) healing outcomes using Biodesign® small intestine submucosa graft compared to autologous temporalis fascia graft.

Detailed Description
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Patients 18 or older will undergo primary canal wall down mastoidectomy. Patients with known biologic sensitivity or cultural objection to use of porcine materials will be excluded. Data will be derived from the medical record and surgeon reports as detailed on pre-op and follow-up forms. Variables collected include age, gender, medical co-morbidities, body mass index, pre-operative audiometric values (including word recognition score, pure tone average, and air bone gap), side of surgery, size of operative cavity, infectious state (draining versus dry), exact surgical procedure, presence of cholesteatoma, time to dry cavity, time to complete epithelialization (as observed directly by the surgeon), and post-operative complications (such as persistent perforation, drainage, granulation tissue formation, and facial nerve outcomes). Dates and patient number will be recorded. Patients will be randomly assigned using randomization software, whereby patients will be assigned a sequential research number that is pre-randomized to one research arm. The study cannot be blinded, as the surgeon will be able to identify which graft will be used. De-identified photographs of the post-operative outcomes at each time point will be recorded photographically. Three physicians will review these photographs without prior knowledge of the treatment arm.

Official Title
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Use of Biodesign® Otologic Graft in Canal Wall Down Mastoidectomy: A Prospective, Randomized Trial

Conditions
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Otologic Disease

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing primary canal wall mastoidectomy Exclusion Criteria: Patients with a known biologic sensitivity or a cultural aversion to the 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 Otologic Graft<br>Graft following canal wall down mastoidectomy. | Biological: Biodesign Otologic graft<br>* Patient's mastoid cavity will be covered with porcine small intestine submucosa, Biodesign.<br>* Other names: Porcine small intestine submucosa;|
| Active Comparator: Autograft temporalis fascia<br>Graft following canal wall down mastoidectomy. | Other: Autograft temporalis fascia<br>* Patient's mastoid cavity will be covered with covered with autograft.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epithelialization of the canal wall down mastoid cavity | Direct observation by surgeon | Evaluation at 1 month post-operatively. | 
| Epithelialization of the canal wall down mastoid cavity | Direct observation by surgeon | Evaluation at 2 months post-operatively. | 
| Epithelialization of the canal wall down mastoid cavity | Direct observation by surgeon | Evaluation at 3 months post-operatively. | 
| Epithelialization of the canal wall down mastoid cavity | Direct observation by surgeon | Evaluation at 6 months post-operatively. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of dry cavity | Direct observation by surgeon | Evaluation at 1 month post-operatively | 
| Determination of dry cavity | Direct observation by surgeon | Evaluation at 2 months post-operatively | 
| Determination of dry cavity | Direct observation by surgeon | Evaluation at 3 months post-operatively | 
| Determination of dry cavity | Direct observation by surgeon | Evaluation at 6 months post-operatively | 
| Audio-metric outcome | Test the pure tone air conduction (average of 500, 1000 and 2000 Hz) | Evaluation at 3 months post-operatively | 
| Audio-metric outcome | Determine the Air Bone Gap by measuring the difference between the air conduction and bone conduction testing. The air bone gap is the difference between the 2 readings and must be present at 3 consecutive frequencies. | Evaluation at 3 months post-operatively | 
| Audio-metric outcome | The word recognition testing evaluates the patient's ability to repeat phonetically balanced words appropriate for their hearing level. | Evaluation at 3 months post-operatively | 
| Audio-metric outcome | Test the pure tone air conduction (average of 500, 1000 and 2000 Hz) | Evaluation at 6 months post-operatively | 
| Audio-metric outcome | Determine the Air Bone Gap by measuring the difference between the air conduction and bone conduction testing. The air bone gap is the difference between the 2 readings and must be present at 3 consecutive frequencies. | Evaluation at 6 months post-operatively | 
| Audio-metric outcome | The word recognition testing evaluates the patient's ability to repeat phonetically balanced words appropriate for their hearing level. | Evaluation at 6 months post-operatively |