Trial | NCT03904316  Report issue

Title

Use of Biodesign® Otologic Graft in Tympanoplasty
Use of Biodesign® Otologic Graft in Tympanoplasty: A Prospective, Randomized Trial

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Withdrawn

  • Study Participants

    0
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 Started
Oct 03
2018
Primary Completion
Jul 01
2022
Study Completion
Jul 01
2022
Last Update
Aug 12
2022

Biological Biodesign Otologic graft

Acellular matrix derived from porcine small intestine submucosa

Other Autologous temporalis fascia

An autologous graft for tympanic membrane repair

Biodesign graft tympanic membrane repair Experimental

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 Active Comparator

Patient's perforated tympanic membrane will be repaired with autologous temporalis fascia.

Criteria 

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.
No Results Posted