NCT03904316

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2018

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 3, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 5, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

December 19, 2025

Status Verified

August 1, 2022

Enrollment Period

3.7 years

First QC Date

March 18, 2019

Last Update Submit

December 15, 2025

Conditions

Tympanic Membrane Perforation

Outcome Measures

Primary Outcomes (4)

  • Assessment of graft take after tympanoplasty

    Microscopically evaluate tympanic membrane for perforation closure

    1 month postoperatively by the surgeon

  • Assessment of graft take after tympanoplasty

    Microscopically evaluate tympanic membrane for perforation closure

    2 months postoperatively by the surgeon

  • Assessment of graft take after tympanoplasty

    Microscopically evaluate tympanic membrane for perforation closure

    3 months postoperatively by the surgeon

  • Assessment of graft take after tympanoplasty

    Microscopically evaluate tympanic membrane for perforation closure

    6 months postoperatively by the surgeon

Secondary Outcomes (9)

  • Measurement of Hearing Parameters

    Measure hearing parameters preoperatively

  • Measurement of Hearing Parameters

    Measure hearing parameters preoperatively.

  • Measurement of Hearing Parameters

    Measure hearing parameters preoperatively

  • Measurement of Hearing Parameters

    Measure hearing parameters 3 months postoperatively

  • Measurement of Hearing Parameters

    Measure hearing parameters 3 months postoperatively

  • +4 more secondary outcomes

Study Arms (2)

Biodesign graft tympanic membrane repair

EXPERIMENTAL

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

Autograft tympanic membrane repair

ACTIVE COMPARATOR

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

Other: Autologous temporalis fascia

Interventions

Autologous temporalis fasciaOTHER

An autologous graft for tympanic membrane repair

Autograft tympanic membrane repair
Biodesign Otologic graftBIOLOGICAL

Acellular matrix derived from porcine small intestine submucosa

Biodesign graft tympanic membrane repair

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing primary tympanoplasty without mastoidectomy.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ascension Providence Hospital, Novi Campus

Novi, Michigan, 48374, United States

Location

Related Publications (19)

  • 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.

    PMID: 14623693BACKGROUND

  • 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.

    PMID: 17710604BACKGROUND

  • 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.

    PMID: 17564175BACKGROUND

  • 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.

    PMID: 23956139BACKGROUND

  • JANSEN C. CARTILAGE--TYMPANOPLASTY. Laryngoscope. 1963 Oct;73:1288-301. doi: 10.1288/00005537-196310000-00006. No abstract available.

    PMID: 14073760BACKGROUND

  • 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.

    PMID: 11306396BACKGROUND

  • 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.

    PMID: 23777420BACKGROUND

  • 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.

    PMID: 29290312BACKGROUND

  • 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.

    PMID: 17287942BACKGROUND

  • 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.

    PMID: 20723784BACKGROUND

  • ORTEGREN U. MYRINGOPLASTY. A 4-YEAR SERIES REVIEWED 2 YEARS AFTER OPERATION. Acta Otolaryngol Suppl. 1964;188:SUPPL 188:234+. No abstract available.

    PMID: 14146678BACKGROUND

  • 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.

    PMID: 24214917BACKGROUND

  • 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.

    PMID: 23032665BACKGROUND

  • 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.

    PMID: 14624898BACKGROUND

  • 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.

    PMID: 18209120BACKGROUND

  • SHEA JJ Jr. Vein graft closure of eardrum perforations. J Laryngol Otol. 1960 Jun;74:358-62. doi: 10.1017/s002221510005670x. No abstract available.

    PMID: 13854782BACKGROUND

  • 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.

    PMID: 16015147BACKGROUND

  • Storrs L. Myringoplasty. Laryngoscope. 1966 Feb;76(2):185-95. doi: 10.1288/00005537-196602000-00001. No abstract available.

    PMID: 5324120BACKGROUND

  • 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.

    PMID: 27273405BACKGROUND

MeSH Terms

Conditions

Tympanic Membrane Perforation

Condition Hierarchy (Ancestors)

Ear DiseasesOtorhinolaryngologic DiseasesWounds and Injuries

Study Officials

  • Seilesh Babu, MD

    Michigan Ear Institute

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2019

First Posted

April 5, 2019

Study Start

October 3, 2018

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

December 19, 2025

Record last verified: 2022-08

Locations

US(1)