Use of Biodesign® Otologic Graft in Canal Wall Down Mastoidectomy: A Prospective, Randomized Trial

Henry Ford Health

Status and phase: Withdrawn; Phase 4

Conditions: Otologic Disease

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03902938

1322212

Details and patient eligibility

About

This is a prospective, randomized trial to evaluate canal wall down mastoidectomy (CWDM) healing outcomes using Biodesign® small intestine submucosa graft compared to autologous temporalis fascia graft.

Full description

Patients 18 or older will undergo primary canal wall down mastoidectomy. Patients with known biologic sensitivity or cultural objection to use of porcine materials will be excluded.

Data will be derived from the medical record and surgeon reports as detailed on pre-op and follow-up forms. Variables collected include age, gender, medical co-morbidities, body mass index, pre-operative audiometric values (including word recognition score, pure tone average, and air bone gap), side of surgery, size of operative cavity, infectious state (draining versus dry), exact surgical procedure, presence of cholesteatoma, time to dry cavity, time to complete epithelialization (as observed directly by the surgeon), and post-operative complications (such as persistent perforation, drainage, granulation tissue formation, and facial nerve outcomes). Dates and patient number will be recorded. Patients will be randomly assigned using randomization software, whereby patients will be assigned a sequential research number that is pre-randomized to one research arm. The study cannot be blinded, as the surgeon will be able to identify which graft will be used. De-identified photographs of the post-operative outcomes at each time point will be recorded photographically. Three physicians will review these photographs without prior knowledge of the treatment arm.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing primary canal wall mastoidectomy

Exclusion criteria

• Patients with a known biologic sensitivity or a cultural aversion to the 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 Otologic Graft

Experimental group

Description:

Graft following canal wall down mastoidectomy.

Treatment:

Biological: Biodesign Otologic graft

Autograft temporalis fascia

Active Comparator group

Description:

Graft following canal wall down mastoidectomy.

Treatment:

Other: Autograft temporalis fascia