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Otologic DiseasePhase 4NCT03902938

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

A Phase 4 study testing Biodesign Otologic graft and Autograft temporalis fascia in people with Otologic Disease, 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Withdrawn

Withdrawn.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 canal wall down mastoidectomy (CWDM) healing outcomes using Biodesign® small intestine submucosa graft compared to autologous temporalis fascia graft. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Otologic Disease
What is being tested?
Biodesign Otologic graft and Autograft temporalis fascia
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
2 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 canal wall mastoidectomy

Who cannot join

  • Patients with a known biologic sensitivity or a cultural aversion to the 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

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.

Read the 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.

Being tested
Biodesign Otologic graft, Autograft temporalis fascia
Medical subject headings
Ear Diseases

What participants receive

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

  • Biodesign Otologic graftBiological

    Also called Porcine small intestine submucosa

    Patient's mastoid cavity will be covered with porcine small intestine submucosa, Biodesign.

  • Autograft temporalis fasciaOther

    Patient's mastoid cavity will be covered with covered with autograft.

Study groups in NCT03902938
Study groupRoleWhat they receive
Biodesign Otologic GraftExperimentalGraft following canal wall down mastoidectomy.
Receives: Biological: Biodesign Otologic graft
Autograft temporalis fasciaActive comparatorGraft following canal wall down mastoidectomy.
Receives: Other: Autograft temporalis fascia

What is being measured

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

  1. Epithelialization of the canal wall down mastoid cavity

    Direct observation by surgeon

    Measured: Evaluation at 1 month post-operatively.

  2. Epithelialization of the canal wall down mastoid cavity

    Direct observation by surgeon

    Measured: Evaluation at 2 months post-operatively.

  3. Epithelialization of the canal wall down mastoid cavity

    Direct observation by surgeon

    Measured: Evaluation at 3 months post-operatively.

  4. Epithelialization of the canal wall down mastoid cavity

    Direct observation by surgeon

    Measured: Evaluation at 6 months post-operatively.

Secondary outcomes (10)

  1. Determination of dry cavity

    Direct observation by surgeon

    Measured: Evaluation at 1 month post-operatively

  2. Determination of dry cavity

    Direct observation by surgeon

    Measured: Evaluation at 2 months post-operatively

  3. Determination of dry cavity

    Direct observation by surgeon

    Measured: Evaluation at 3 months post-operatively

  4. Determination of dry cavity

    Direct observation by surgeon

    Measured: Evaluation at 6 months post-operatively

  5. Audio-metric outcome

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

    Measured: Evaluation at 3 months post-operatively

  6. Audio-metric outcome

    Determine the Air Bone Gap by measuring the difference between the air conduction and bone conduction testing. The air bone gap is the difference between the 2 readings and must be present at 3 consecutive frequencies.

    Measured: Evaluation at 3 months post-operatively

  7. Audio-metric outcome

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

    Measured: Evaluation at 3 months post-operatively

  8. Audio-metric outcome

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

    Measured: Evaluation at 6 months post-operatively

  9. Audio-metric outcome

    Determine the Air Bone Gap by measuring the difference between the air conduction and bone conduction testing. The air bone gap is the difference between the 2 readings and must be present at 3 consecutive frequencies.

    Measured: Evaluation at 6 months post-operatively

  10. Audio-metric outcome

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

    Measured: Evaluation at 6 months post-operatively

Timeline

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

  1. First posted4 Apr 2019
  2. Study start2 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 the 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
NCT03902938
Sponsor's protocol ID
1322212
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

  • Chhapola S, Matta I. Mastoid obliteration versus open cavity: a comparative study. Indian J Otolaryngol Head Neck Surg. 2014 Jan;66(Suppl 1):207-13. doi: 10.1007/s12070-011-0429-x. Epub 2012 Jan 1.

    PubMed 24533385

  • Gantz BJ, Wilkinson EP, Hansen MR. Canal wall reconstruction tympanomastoidectomy with mastoid obliteration. Laryngoscope. 2005 Oct;115(10):1734-40. doi: 10.1097/01.MLG.0000187572.99335.cc.

    PubMed 16222186

  • 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

  • Kanazawa Y, Shojaku H, Okabe M, Fujisaka M, Takakura H, Tachino H, Tsubota M, Watanabe Y, Nikaido T. Application of hyperdry amniotic membrane patches without fibrin glue over the bony surface of mastoid cavities in canal wall down tympanoplasty. Acta Otolaryngol. 2012 Dec;132(12):1282-7. doi: 10.3109/00016489.2012.701329. Epub 2012 Nov 6.

    PubMed 23126613

  • 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

  • Kobayashi T, Gyo K, Komori M, Hyodo M. Polyglycolic acid sheet attached with fibrin glue can facilitate faster epithelialization of the mastoid cavity after canal wall-down tympanoplasty. Auris Nasus Larynx. 2017 Dec;44(6):685-689. doi: 10.1016/j.anl.2017.01.013. Epub 2017 Feb 20.

    PubMed 28215637

  • 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

  • Martini A, Morra B, Aimoni C, Radice M. Use of a hyaluronan-based biomembrane in the treatment of chronic cholesteatomatous otitis media. Am J Otol. 2000 Jul;21(4):468-73.

    PubMed 10912689

  • 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

  • Palva T. Surgical treatment of chronic middle ear disease. II. Canal wall up and canal wall down procedures. Acta Otolaryngol. 1987 Nov-Dec;104(5-6):487-94. doi: 10.3109/00016488709128279.

    PubMed 3434271

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Biodesign Otologic graft and Autograft temporalis fascia in people with Otologic Disease, 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?

Epithelialization of the canal wall down mastoid cavity (time frame: Evaluation at 1 month post-operatively.). 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 NCT03902938, 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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