Use of Biodesign® Otologic Graft in Tympanoplasty
December 15, 2025 updated by: Henry Ford Health System
Use of Biodesign® Otologic Graft in Tympanoplasty: A Prospective, Randomized Trial
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Novi, Michigan, United States, 48374
- Ascension Providence Hospital, Novi Campus
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Biodesign graft tympanic membrane repair
Patient's perforated tympanic membrane will be repaired with an acellular matrix derived from porcine small intestine submucosa, Biodesign Otologic graft
|
Acellular matrix derived from porcine small intestine submucosa
|
|
Active Comparator: Autograft tympanic membrane repair
Patient's perforated tympanic membrane will be repaired with autologous temporalis fascia.
|
An autologous graft for tympanic membrane repair
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of graft take after tympanoplasty
Time Frame: 1 month postoperatively by the surgeon
|
Microscopically evaluate tympanic membrane for perforation closure
|
1 month postoperatively by the surgeon
|
|
Assessment of graft take after tympanoplasty
Time Frame: 2 months postoperatively by the surgeon
|
Microscopically evaluate tympanic membrane for perforation closure
|
2 months postoperatively by the surgeon
|
|
Assessment of graft take after tympanoplasty
Time Frame: 3 months postoperatively by the surgeon
|
Microscopically evaluate tympanic membrane for perforation closure
|
3 months postoperatively by the surgeon
|
|
Assessment of graft take after tympanoplasty
Time Frame: 6 months postoperatively by the surgeon
|
Microscopically evaluate tympanic membrane for perforation closure
|
6 months postoperatively by the surgeon
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measurement of Hearing Parameters
Time Frame: Measure hearing parameters preoperatively
|
Test the pure tone conduction (average of 500, 1000 and 2000 Hz).
|
Measure hearing parameters preoperatively
|
|
Measurement of Hearing Parameters
Time Frame: Measure hearing parameters preoperatively.
|
Test the Air Bone Gap starting at 1000 Hz then 2000, 4000, 8000, 250 and 500 for air-conduction thresholds.
Then test non-masked bone-conduction thresholds at the same frequencies.
|
Measure hearing parameters preoperatively.
|
|
Measurement of Hearing Parameters
Time Frame: Measure hearing parameters preoperatively
|
Test Word Recognition for 50-2 syllables words
|
Measure hearing parameters preoperatively
|
|
Measurement of Hearing Parameters
Time Frame: Measure hearing parameters 3 months postoperatively
|
Test the pure tone conduction (average of 500, 1000 and 2000 Hz).
|
Measure hearing parameters 3 months postoperatively
|
|
Measurement of Hearing Parameters
Time Frame: Measure hearing parameters 3 months postoperatively
|
Determine the air bond gap by measuring the difference between the air conduction and gone conduction testing.
The air bone gap is the difference between the 2 readings and must be present at 3 consecutive frequencies.
|
Measure hearing parameters 3 months postoperatively
|
|
Measurement of Hearing Parameters
Time Frame: Measure hearing parameters 3 months postoperatively
|
The word recognition testing evaluates the patient's ability to repeat phonetically balanced words appropriate for his/her hearing level.
|
Measure hearing parameters 3 months postoperatively
|
|
Measurement of Hearing Parameters
Time Frame: Measure hearing parameters 6 months postoperatively
|
Test the pure tone conduction (average of 500, 1000 and 2000 Hz).
|
Measure hearing parameters 6 months postoperatively
|
|
Measurement of Hearing Parameters
Time Frame: Measure hearing parameters 6 months postoperatively
|
Determine the air bond gap by measuring the difference between the air conduction and gone conduction testing.
The air bone gap is the difference between the 2 readings and must be present at 3 consecutive frequencies.
|
Measure hearing parameters 6 months postoperatively
|
|
Measurement of Hearing Parameters
Time Frame: Measure hearing parameters 6 months postoperatively
|
The word recognition testing evaluates the patient's ability to repeat phonetically balanced words appropriate for his/her hearing level.
|
Measure hearing parameters 6 months postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Seilesh Babu, MD, Michigan Ear Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ambro BT, Zimmerman J, Rosenthal M, Pribitkin EA. Nasal septal perforation repair with porcine small intestinal submucosa. Arch Facial Plast Surg. 2003 Nov-Dec;5(6):528-9. doi: 10.1001/archfaci.5.6.528.
- Ansaloni L, Cambrini P, Catena F, Di Saverio S, Gagliardi S, Gazzotti F, Hodde JP, Metzger DW, D'Alessandro L, Pinna AD. Immune response to small intestinal submucosa (surgisis) implant in humans: preliminary observations. J Invest Surg. 2007 Jul-Aug;20(4):237-41. doi: 10.1080/08941930701481296.
- Bejjani GK, Zabramski J; Durasis Study Group. Safety and efficacy of the porcine small intestinal submucosa dural substitute: results of a prospective multicenter study and literature review. J Neurosurg. 2007 Jun;106(6):1028-33. doi: 10.3171/jns.2007.106.6.1028.
- Illing E, Chaaban MR, Riley KO, Woodworth BA. Porcine small intestine submucosal graft for endoscopic skull base reconstruction. Int Forum Allergy Rhinol. 2013 Nov;3(11):928-32. doi: 10.1002/alr.21206. Epub 2013 Aug 16.
- Knoll LD. Use of porcine small intestinal submucosal graft in the surgical management of Peyronie's disease. Urology. 2001 Apr;57(4):753-7. doi: 10.1016/s0090-4295(00)01079-7.
- Lin HK, Godiwalla SY, Palmer B, Frimberger D, Yang Q, Madihally SV, Fung KM, Kropp BP. Understanding roles of porcine small intestinal submucosa in urinary bladder regeneration: identification of variable regenerative characteristics of small intestinal submucosa. Tissue Eng Part B Rev. 2014 Feb;20(1):73-83. doi: 10.1089/ten.TEB.2013.0126. Epub 2013 Jul 25.
- Murphy F, Corbally MT. The novel use of small intestinal submucosal matrix for chest wall reconstruction following Ewing's tumour resection. Pediatr Surg Int. 2007 Apr;23(4):353-6. doi: 10.1007/s00383-007-1882-1. Epub 2007 Feb 8.
- Ort SA, Ehrlich HP, Isaacson JE. Acellular porcine intestinal submucosa as fascial graft in an animal model: applications for revision tympanoplasty. Otolaryngol Head Neck Surg. 2010 Sep;143(3):435-40. doi: 10.1016/j.otohns.2010.04.268.
- Rutner AB, Levine SR, Schmaelzle JF. Processed porcine small intestine submucosa as a graft material for pubovaginal slings: durability and results. Urology. 2003 Nov;62(5):805-9. doi: 10.1016/s0090-4295(03)00664-2.
- Seymour PE, Leventhal DD, Pribitkin EA. Lip augmentation with porcine small intestinal submucosa. Arch Facial Plast Surg. 2008 Jan-Feb;10(1):30-3. doi: 10.1001/archfacial.2007.17.
- Spiegel JH, Kessler JL. Tympanic membrane perforation repair with acellular porcine submucosa. Otol Neurotol. 2005 Jul;26(4):563-6. doi: 10.1097/01.mao.0000169636.63440.4e.
- JANSEN C. CARTILAGE--TYMPANOPLASTY. Laryngoscope. 1963 Oct;73:1288-301. doi: 10.1288/00005537-196310000-00006. No abstract available.
- Min J, Kim SH. Comparison of transcanal endoscopic tympanoplasty with sterile acellular dermal allograft to conventional endaural microscopic tympanoplasty with tragal perichondrium. Am J Otolaryngol. 2018 Mar-Apr;39(2):167-170. doi: 10.1016/j.amjoto.2017.11.014. Epub 2017 Dec 7.
- ORTEGREN U. MYRINGOPLASTY. A 4-YEAR SERIES REVIEWED 2 YEARS AFTER OPERATION. Acta Otolaryngol Suppl. 1964;188:SUPPL 188:234+. No abstract available.
- Phillips J, Riley KO, Woodworth BA. Porcine small intestine submucosal grafts for post-tumor resection orbital reconstruction. Laryngoscope. 2014 Jun;124(6):E219-23. doi: 10.1002/lary.24515. Epub 2013 Dec 18.
- Van Rompaey V, Farr MR, Hamans E, Mudry A, Van de Heyning PH. Allograft tympanoplasty: a historical perspective. Otol Neurotol. 2013 Jan;34(1):180-8. doi: 10.1097/MAO.0b013e31826bf16d.
- SHEA JJ Jr. Vein graft closure of eardrum perforations. J Laryngol Otol. 1960 Jun;74:358-62. doi: 10.1017/s002221510005670x. No abstract available.
- Storrs L. Myringoplasty. Laryngoscope. 1966 Feb;76(2):185-95. doi: 10.1288/00005537-196602000-00001. No abstract available.
- Tan HE, Santa Maria PL, Eikelboom RH, Anandacoomaraswamy KS, Atlas MD. Type I Tympanoplasty Meta-Analysis: A Single Variable Analysis. Otol Neurotol. 2016 Aug;37(7):838-46. doi: 10.1097/MAO.0000000000001099.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 3, 2018
Primary Completion (Actual)
July 1, 2022
Study Completion (Actual)
July 1, 2022
Study Registration Dates
First Submitted
March 18, 2019
First Submitted That Met QC Criteria
April 3, 2019
First Posted (Actual)
April 5, 2019
Study Record Updates
Last Update Posted (Estimated)
December 19, 2025
Last Update Submitted That Met QC Criteria
December 15, 2025
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1322227
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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