CClinicalTrials.gg
Sign In
WithdrawnNCT03904316Updated Dec 19, 2025

Use of Biodesign® Otologic Graft in Tympanoplasty

A Phase 4 interventional study of Biodesign Otologic graft and Autologous temporalis fascia in Tympanic Membrane Perforation, sponsored by Henry Ford Health System. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-19.

Sponsored by Henry Ford Health System · Phase 4, Interventional, and Treatment

Why this study was withdrawn
The trial was stopped as the benefit was challenging to determine in preliminary usage.

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Oct 2018, registered Mar 2019).
Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Tympanic Membrane Perforation
03

In context

Tympanic Membrane Perforation

45 studies on the registry are indexed under Tympanic Membrane Perforation; 10 are open to participants now.

Browse Tympanic Membrane Perforation studies →

Lead sponsor

Henry Ford Health System is the lead sponsor of 293 studies on the registry; 50 are open to participants now.

Of its 35 completed or terminated interventional studies of FDA-regulated products, 23 (66%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients undergoing primary tympanoplasty without mastoidectomy.

Exclusion criteria

Exclusion Criteria:

  • Patients with a known biologic sensitivity or a cultural objection to use of porcine materials.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • 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

    Biological: Biodesign Otologic graft

  • Active comparator
    Autograft tympanic membrane repair

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

    Other: Autologous temporalis fascia

Interventions

  • BiologicalBiodesign Otologic graft

    Acellular matrix derived from porcine small intestine submucosa

  • OtherAutologous temporalis fascia

    An autologous graft for tympanic membrane repair

06

What researchers measure

Primary outcomes

  1. Assessment of graft take after tympanoplasty

    Microscopically evaluate tympanic membrane for perforation closure

    Time frame: 1 month postoperatively by the surgeon

  2. Assessment of graft take after tympanoplasty

    Microscopically evaluate tympanic membrane for perforation closure

    Time frame: 2 months postoperatively by the surgeon

  3. Assessment of graft take after tympanoplasty

    Microscopically evaluate tympanic membrane for perforation closure

    Time frame: 3 months postoperatively by the surgeon

  4. Assessment of graft take after tympanoplasty

    Microscopically evaluate tympanic membrane for perforation closure

    Time frame: 6 months postoperatively by the surgeon

Secondary outcomes

  1. Measurement of Hearing Parameters

    Test the pure tone conduction (average of 500, 1000 and 2000 Hz).

    Time frame: Measure hearing parameters preoperatively

  2. Measurement of Hearing Parameters

    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.

    Time frame: Measure hearing parameters preoperatively.

  3. Measurement of Hearing Parameters

    Test Word Recognition for 50-2 syllables words

    Time frame: Measure hearing parameters preoperatively

  4. Measurement of Hearing Parameters

    Test the pure tone conduction (average of 500, 1000 and 2000 Hz).

    Time frame: Measure hearing parameters 3 months postoperatively

  5. Measurement of Hearing Parameters

    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.

    Time frame: Measure hearing parameters 3 months postoperatively

  6. Measurement of Hearing Parameters

    The word recognition testing evaluates the patient's ability to repeat phonetically balanced words appropriate for his/her hearing level.

    Time frame: Measure hearing parameters 3 months postoperatively

  7. Measurement of Hearing Parameters

    Test the pure tone conduction (average of 500, 1000 and 2000 Hz).

    Time frame: Measure hearing parameters 6 months postoperatively

  8. Measurement of Hearing Parameters

    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.

    Time frame: Measure hearing parameters 6 months postoperatively

  9. Measurement of Hearing Parameters

    The word recognition testing evaluates the patient's ability to repeat phonetically balanced words appropriate for his/her hearing level.

    Time frame: Measure hearing parameters 6 months postoperatively

07

Study locations

1 site
  • Ascension Providence Hospital, Novi Campus
    Novi, Michigan 48374, United States
08

References and documents

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. PubMed 14623693 ↗
  • 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. PubMed 17710604 ↗
  • 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. PubMed 17564175 ↗
  • 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. PubMed 23956139 ↗
  • JANSEN C. CARTILAGE--TYMPANOPLASTY. Laryngoscope. 1963 Oct;73:1288-301. doi: 10.1288/00005537-196310000-00006. No abstract available. PubMed 14073760 ↗
  • 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. PubMed 11306396 ↗
  • 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. PubMed 23777420 ↗
  • 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. PubMed 29290312 ↗
  • 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. PubMed 17287942 ↗
  • 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. PubMed 20723784 ↗
  • ORTEGREN U. MYRINGOPLASTY. A 4-YEAR SERIES REVIEWED 2 YEARS AFTER OPERATION. Acta Otolaryngol Suppl. 1964;188:SUPPL 188:234+. No abstract available. PubMed 14146678 ↗
  • 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. PubMed 24214917 ↗
  • 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. PubMed 23032665 ↗
  • 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. PubMed 14624898 ↗
  • 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. PubMed 18209120 ↗
  • SHEA JJ Jr. Vein graft closure of eardrum perforations. J Laryngol Otol. 1960 Jun;74:358-62. doi: 10.1017/s002221510005670x. No abstract available. PubMed 13854782 ↗
  • 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. PubMed 16015147 ↗
  • Storrs L. Myringoplasty. Laryngoscope. 1966 Feb;76(2):185-95. doi: 10.1288/00005537-196602000-00001. No abstract available. PubMed 5324120 ↗
  • 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. PubMed 27273405 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03904316
Lead sponsor
Henry Ford Health System
Responsible party
Sponsor
First posted
Apr 5, 2019
Start date
Oct 3, 2018
Primary completion
Jul 1, 2022
Completion
Jul 1, 2022
Last update
Dec 19, 2025

Study contacts

Seilesh Babu, MD
principal investigator · Michigan Ear Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Tympanic Membrane Perforation→

Other studies from this sponsor

Henry Ford Health System

Start the discussion