Use of Biodesign® Otologic Graft in Tympanoplasty

Overview

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.

Full Title of Study: “Use of Biodesign® Otologic Graft in Tympanoplasty: A Prospective, Randomized Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 3, 2019

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

  • Biological: Biodesign Otologic graft
    • Acellular matrix derived from porcine small intestine submucosa
  • Other: Autologous temporalis fascia
    • An autologous graft for tympanic membrane repair

Arms, Groups and Cohorts

  • Experimental: Biodesign graft tympanic membrane repair
    • Patient’s perforated tympanic membrane will be repaired with an acellular matrix derived from porcine small intestine submucosa, Biodesign Otologic graft
  • Active Comparator: Autograft tympanic membrane repair
    • Patient’s perforated tympanic membrane will be repaired with autologous temporalis fascia.

Clinical Trial Outcome Measures

Primary Measures

  • Assessment of graft take after tympanoplasty
    • Time Frame: 1 month postoperatively by the surgeon
    • Microscopically evaluate tympanic membrane for perforation closure
  • Assessment of graft take after tympanoplasty
    • Time Frame: 2 months postoperatively by the surgeon
    • Microscopically evaluate tympanic membrane for perforation closure
  • Assessment of graft take after tympanoplasty
    • Time Frame: 3 months postoperatively by the surgeon
    • Microscopically evaluate tympanic membrane for perforation closure
  • Assessment of graft take after tympanoplasty
    • Time Frame: 6 months postoperatively by the surgeon
    • Microscopically evaluate tympanic membrane for perforation closure

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ascension South East Michigan
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Seilesh Babu, MD, Principal Investigator, Michigan Ear Institute
  • Overall Contact(s)
    • Seilesh Babu, MD, (248) 865-4444, sbabu@gmail.com

References

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Seymour PE, Leventhal DD, Pribitkin EA. Lip augmentation with porcine small intestinal submucosa. Arch Facial Plast Surg. 2008 Jan-Feb;10(1):30-3. doi: 10.1001/archfacial.2007.17.

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Tan HE, Santa Maria PL, Eikelboom RH, Anandacoomaraswamy KS, Atlas MD. Type I Tympanoplasty Meta-Analysis: A Single Variable Analysis. Otol Neurotol. 2016 Aug;37(7):838-46. doi: 10.1097/MAO.0000000000001099.

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