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Use of Biodesign® Otologic Graft in Tympanoplasty

NCT03904316 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2025-12-19

No results posted yet for this study

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.

Conditions

  • Tympanic Membrane Perforation

Interventions

BIOLOGICAL

Biodesign Otologic graft

Acellular matrix derived from porcine small intestine submucosa

OTHER

Autologous temporalis fascia

An autologous graft for tympanic membrane repair

Sponsors & Collaborators

  • Henry Ford Health System

    lead OTHER

Principal Investigators

  • Seilesh Babu, MD · Michigan Ear Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-03
Primary Completion
2022-07-01
Completion
2022-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03904316 on ClinicalTrials.gov