Clinical trial NCT03902938: Use of Biodesign® Otologic Graft in Canal Wall Down Mastoidectomy: A Prospective, Randomized Trial
Official title: Use of Biodesign® Otologic Graft in Canal Wall Down Mastoidectomy: A Prospective, Randomized Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Otologic Disease
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2019-04-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Epithelialization of the canal wall down mastoid cavity
timeFrame: Evaluation at 1 month post-operatively.
measure: Epithelialization of the canal wall down mastoid cavity
timeFrame: Evaluation at 2 months post-operatively.
measure: Epithelialization of the canal wall down mastoid cavity
timeFrame: Evaluation at 3 months post-operatively.
measure: Epithelialization of the canal wall down mastoid cavity
timeFrame: Evaluation at 6 months post-operatively.
Secondary outcomes:
measure: Determination of dry cavity
timeFrame: Evaluation at 1 month post-operatively
measure: Determination of dry cavity
timeFrame: Evaluation at 2 months post-operatively
measure: Determination of dry cavity
timeFrame: Evaluation at 3 months post-operatively
measure: Determination of dry cavity
timeFrame: Evaluation at 6 months post-operatively
measure: Audio-metric outcome
timeFrame: Evaluation at 3 months post-operatively
measure: Audio-metric outcome
timeFrame: Evaluation at 3 months post-operatively
measure: Audio-metric outcome
timeFrame: Evaluation at 3 months post-operatively
measure: Audio-metric outcome
timeFrame: Evaluation at 6 months post-operatively
measure: Audio-metric outcome
timeFrame: Evaluation at 6 months post-operatively
measure: Audio-metric outcome
timeFrame: Evaluation at 6 months post-operatively
Other outcomes:
Locations:
city: Novi
country: United States
facility: Ascension Providence Hospital, Novi Campus
state: Michigan
Study officials:
affiliation: Physician of record
name: Seilesh Babu, MD
role: PRINCIPAL_INVESTIGATOR
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