Use of Biodesign® Otologic Graft in Tympanoplasty

Phase 4

Withdrawn

• Conditions: Tympanic Membrane Perforation
• Interventions: Biological: Biodesign Otologic graft; Other: Autologous temporalis fascia

• Registration Number: NCT03904316
• Lead Sponsor: Ascension South East Michigan

Brief Summary

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

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 Timeline

• Study Start: 2018-10-03
• Study First Submitted: 2019-03-18
• Study First Submitted QC: 2019-04-03
• Study First Posted: 2019-04-05
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-10
• Last Update Posted: 2022-08-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biodesign graft tympanic membrane repair	Biodesign Otologic graft	Patient's perforated tympanic membrane will be repaired with an acellular matrix derived from porcine small intestine submucosa, Biodesign Otologic graft
Autograft tympanic membrane repair	Autologous temporalis fascia	Patient's perforated tympanic membrane will be repaired with autologous temporalis fascia.

Primary Outcome Measures

Name	Time	Method
Assessment of graft take after tympanoplasty	6 months postoperatively by the surgeon	Microscopically evaluate tympanic membrane for perforation closure

Secondary Outcome Measures

Name	Time	Method
Measurement of Hearing Parameters	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.

Trial Locations

Locations (1)

Ascension Providence Hospital, Novi Campus; 🇺🇸 Novi, Michigan, United States