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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Acellular matrix derived from porcine small intestine submucosa
An autologous graft for tympanic membrane repair
Ascension Providence Hospital, Novi Campus
Novi, Michigan, United States
Assessment of graft take after tympanoplasty
Microscopically evaluate tympanic membrane for perforation closure
Time frame: 1 month postoperatively by the surgeon
Assessment of graft take after tympanoplasty
Microscopically evaluate tympanic membrane for perforation closure
Time frame: 2 months postoperatively by the surgeon
Assessment of graft take after tympanoplasty
Microscopically evaluate tympanic membrane for perforation closure
Time frame: 3 months postoperatively by the surgeon
Assessment of graft take after tympanoplasty
Microscopically evaluate tympanic membrane for perforation closure
Time frame: 6 months postoperatively by the surgeon
Measurement of Hearing Parameters
Test the pure tone conduction (average of 500, 1000 and 2000 Hz).
Time frame: 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.
Time frame: Measure hearing parameters preoperatively.
Measurement of Hearing Parameters
Test Word Recognition for 50-2 syllables words
Time frame: Measure hearing parameters preoperatively
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Measurement of Hearing Parameters
Test the pure tone conduction (average of 500, 1000 and 2000 Hz).
Time frame: 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.
Time frame: 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.
Time frame: Measure hearing parameters 3 months postoperatively
Measurement of Hearing Parameters
Test the pure tone conduction (average of 500, 1000 and 2000 Hz).
Time frame: 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.
Time frame: 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.
Time frame: Measure hearing parameters 6 months postoperatively