WithdrawnPhase 4

Use of Biodesign® Otologic Graft in Tympanoplasty

Stopped: The trial was stopped as the benefit was challenging to determine in preliminary usage.

United States0Started 2018-10-03

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Assessment of graft take after tympanoplasty

Timeframe: 1 month postoperatively by the surgeon

Assessment of graft take after tympanoplasty

Timeframe: 2 months postoperatively by the surgeon

Assessment of graft take after tympanoplasty

Timeframe: 3 months postoperatively by the surgeon

Assessment of graft take after tympanoplasty

Timeframe: 6 months postoperatively by the surgeon

Trial details

NCT IDNCT03904316

SponsorHenry Ford Health System

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-01

View on ClinicalTrials.gov More Tympanic Membrane Perforation trials