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

Phase 4

Withdrawn

• Conditions: Otologic Disease
• Interventions: Other: Autograft temporalis fascia; Biological: Biodesign Otologic graft

• Registration Number: NCT03902938
• Lead Sponsor: Ascension South East Michigan

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.

Study Timeline

• Study Start: 2018-10-02
• Study First Submitted: 2019-03-18
• Study First Submitted QC: 2019-04-02
• Study First Posted: 2019-04-04
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-10
• Last Update Posted: 2022-08-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Autograft temporalis fascia	Autograft temporalis fascia	Graft following canal wall down mastoidectomy.
Biodesign Otologic Graft	Biodesign Otologic graft	Graft following canal wall down mastoidectomy.

Primary Outcome Measures

Name	Time	Method
Epithelialization of the canal wall down mastoid cavity	Evaluation at 6 months post-operatively.	Direct observation by surgeon

Secondary Outcome Measures

Name	Time	Method
Audio-metric outcome	Evaluation at 6 months post-operatively	The word recognition testing evaluates the patient's ability to repeat phonetically balanced words appropriate for their hearing level.
Determination of dry cavity	Evaluation at 6 months post-operatively	Direct observation by surgeon

Trial Locations

Locations (1)

Ascension Providence Hospital, Novi Campus; 🇺🇸 Novi, Michigan, United States