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Tympanic Membrane PerforationPhase 4NCT03904316

Use of Biodesign® Otologic Graft in Tympanoplasty

A Phase 4 study testing Biodesign Otologic graft and Autologous temporalis fascia in people with Tympanic Membrane Perforation, run by Henry Ford Health System at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tympanic Membrane Perforation
What is being tested?
Biodesign Otologic graft and Autologous temporalis fascia
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
3 Oct 2018to 1 Jul 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients undergoing primary tympanoplasty without mastoidectomy.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Ascension Providence Hospital, Novi Campus

    Novi, Michigan, 48374

Other trials in United States

About this study

Official title: 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.

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.

Being tested
Biodesign Otologic graft, Autologous temporalis fascia
Medical subject headings
Tympanic Membrane Perforation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biodesign Otologic graftBiological

    Acellular matrix derived from porcine small intestine submucosa

  • Autologous temporalis fasciaOther

    An autologous graft for tympanic membrane repair

Study groups in NCT03904316
Study groupRoleWhat they receive
Biodesign graft tympanic membrane repairExperimentalPatient's perforated tympanic membrane will be repaired with an acellular matrix derived from porcine small intestine submucosa, Biodesign Otologic graft
Receives: Biological: Biodesign Otologic graft
Autograft tympanic membrane repairActive comparatorPatient's perforated tympanic membrane will be repaired with autologous temporalis fascia.
Receives: Other: Autologous temporalis fascia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of graft take after tympanoplasty

    Microscopically evaluate tympanic membrane for perforation closure

    Measured: 1 month postoperatively by the surgeon

  2. Assessment of graft take after tympanoplasty

    Microscopically evaluate tympanic membrane for perforation closure

    Measured: 2 months postoperatively by the surgeon

  3. Assessment of graft take after tympanoplasty

    Microscopically evaluate tympanic membrane for perforation closure

    Measured: 3 months postoperatively by the surgeon

  4. Assessment of graft take after tympanoplasty

    Microscopically evaluate tympanic membrane for perforation closure

    Measured: 6 months postoperatively by the surgeon

Secondary outcomes (9)

  1. Measurement of Hearing Parameters

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

    Measured: 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.

    Measured: Measure hearing parameters preoperatively.

  3. Measurement of Hearing Parameters

    Test Word Recognition for 50-2 syllables words

    Measured: Measure hearing parameters preoperatively

  4. Measurement of Hearing Parameters

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

    Measured: 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.

    Measured: 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.

    Measured: Measure hearing parameters 3 months postoperatively

  7. Measurement of Hearing Parameters

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

    Measured: 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.

    Measured: 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.

    Measured: Measure hearing parameters 6 months postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2019
  2. Study start3 Oct 2018
  3. Primary completion1 Jul 2022
  4. Study completion1 Jul 2022

Why it stopped: The trial was stopped as the benefit was challenging to determine in preliminary usage.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03904316
Sponsor's protocol ID
1322227
Status last verified
Aug 2022
First submitted
18 Mar 2019
Last updated
19 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Biodesign Otologic graft and Autologous temporalis fascia in people with Tympanic Membrane Perforation, run by Henry Ford Health System at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of graft take after tympanoplasty (time frame: 1 month postoperatively by the surgeon). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03904316, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.

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