Use of Biodesign® Otologic Graft in Tympanoplasty

Henry Ford Health

Status and phase: Withdrawn; Phase 4

Conditions: Tympanic Membrane Perforation

Treatments: Other: Autologous temporalis fascia; Biological: Biodesign Otologic graft

Study type: Interventional

Funder types: Other

Identifiers

NCT03904316

1322227

Details and patient eligibility

About

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 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Biodesign graft tympanic membrane repair

Experimental group

Description:

Patient's perforated tympanic membrane will be repaired with an acellular matrix derived from porcine small intestine submucosa, Biodesign Otologic graft

Treatment:

Biological: Biodesign Otologic graft

Autograft tympanic membrane repair

Active Comparator group

Description:

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

Treatment:

Other: Autologous temporalis fascia