A Phase 4 interventional study of Biodesign Otologic graft and Autograft temporalis fascia in Otologic Disease, sponsored by Henry Ford Health System. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-19.
Sponsored by Henry Ford Health System · Phase 4, Interventional, and Treatment
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.
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.
48 studies on the registry are indexed under Ear Diseases; 10 are open to participants now.
Browse Ear Diseases studies →Henry Ford Health System is the lead sponsor of 303 studies on the registry; 50 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 26 (70%) have results posted.
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Exclusion Criteria:
Graft following canal wall down mastoidectomy.
Biological: Biodesign Otologic graft
Graft following canal wall down mastoidectomy.
Other: Autograft temporalis fascia
Patient's mastoid cavity will be covered with porcine small intestine submucosa, Biodesign.
Also known as: Porcine small intestine submucosa
Patient's mastoid cavity will be covered with covered with autograft.
Epithelialization of the canal wall down mastoid cavity
Direct observation by surgeon
Time frame: Evaluation at 1 month post-operatively.
Epithelialization of the canal wall down mastoid cavity
Direct observation by surgeon
Time frame: Evaluation at 2 months post-operatively.
Epithelialization of the canal wall down mastoid cavity
Direct observation by surgeon
Time frame: Evaluation at 3 months post-operatively.
Epithelialization of the canal wall down mastoid cavity
Direct observation by surgeon
Time frame: Evaluation at 6 months post-operatively.
Determination of dry cavity
Direct observation by surgeon
Time frame: Evaluation at 1 month post-operatively
Determination of dry cavity
Direct observation by surgeon
Time frame: Evaluation at 2 months post-operatively
Determination of dry cavity
Direct observation by surgeon
Time frame: Evaluation at 3 months post-operatively
Determination of dry cavity
Direct observation by surgeon
Time frame: Evaluation at 6 months post-operatively
Audio-metric outcome
Test the pure tone air conduction (average of 500, 1000 and 2000 Hz)
Time frame: 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.
Time frame: 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.
Time frame: Evaluation at 3 months post-operatively
Audio-metric outcome
Test the pure tone air conduction (average of 500, 1000 and 2000 Hz)
Time frame: 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.
Time frame: 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.
Time frame: Evaluation at 6 months post-operatively
Ran from Oct 2018 to primary completion in Jul 2022, 44 months.
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This study is withdrawn, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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