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

NCT03902938 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 1322212
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Otologic Disease

Outcome Measures

Primary Outcomes (4)

• Epithelialization of the canal wall down mastoid cavity

  Direct observation by surgeon

  Evaluation at 1 month post-operatively.

• Epithelialization of the canal wall down mastoid cavity

  Direct observation by surgeon

  Evaluation at 2 months post-operatively.

• Epithelialization of the canal wall down mastoid cavity

  Direct observation by surgeon

  Evaluation at 3 months post-operatively.

• Epithelialization of the canal wall down mastoid cavity

  Direct observation by surgeon

  Evaluation at 6 months post-operatively.

Secondary Outcomes (10)

• Determination of dry cavity

  Evaluation at 1 month post-operatively

• Determination of dry cavity

  Evaluation at 2 months post-operatively

• Determination of dry cavity

  Evaluation at 3 months post-operatively

• Determination of dry cavity

  Evaluation at 6 months post-operatively

• Audio-metric outcome

  Evaluation at 3 months post-operatively

Study Arms (2)

Biodesign Otologic Graft

EXPERIMENTAL

Graft following canal wall down mastoidectomy.

Biological: Biodesign Otologic graft

Autograft temporalis fascia

ACTIVE COMPARATOR

Graft following canal wall down mastoidectomy.

Other: Autograft temporalis fascia

Interventions

Biodesign Otologic graft BIOLOGICAL

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

Also known as: Porcine small intestine submucosa

Biodesign Otologic Graft

Autograft temporalis fascia OTHER

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

Autograft temporalis fascia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing primary canal wall mastoidectomy

You may not qualify if:

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

Sponsors & Collaborators

• Henry Ford Health System: lead

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: 14623693 BACKGROUND

• 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: 17710604 BACKGROUND

• 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: 17564175 BACKGROUND

• 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.

  PMID: 24533385 BACKGROUND

• 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.

  PMID: 16222186 BACKGROUND

• 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: 23956139 BACKGROUND

• 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.

  PMID: 23126613 BACKGROUND

• 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: 11306396 BACKGROUND

• 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.

  PMID: 28215637 BACKGROUND

• 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: 23777420 BACKGROUND

• 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.

  PMID: 10912689 BACKGROUND

• 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: 17287942 BACKGROUND

• 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: 20723784 BACKGROUND

• 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.

  PMID: 3434271 BACKGROUND

• 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: 14624898 BACKGROUND

• 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: 18209120 BACKGROUND

• Sheehy JL. Cholesteatoma surgery: canal wall down procedures. Ann Otol Rhinol Laryngol. 1988 Jan-Feb;97(1):30-5. doi: 10.1177/000348948809700106.

  PMID: 3277524 BACKGROUND

• 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: 16015147 BACKGROUND

• Wetmore SJ, Bueller HA, Cost JL. Split thickness skin grafting in canal wall down tympanomastoidectomy. Otol Neurotol. 2014 Jan;35(1):97-100. doi: 10.1097/MAO.0b013e3182a4445d.

  PMID: 24136321 BACKGROUND

MeSH Terms

Conditions

Ear Diseases

Condition Hierarchy (Ancestors)

Otorhinolaryngologic Diseases

Study Officials

• Seilesh Babu, MD

  Physician of record

  PRINCIPAL INVESTIGATOR

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 4, 2019
• Study Start: October 2, 2018
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: December 19, 2025

Record last verified: 2022-08

Locations

US (1)