Use of Biodesign® Otologic Graft in Canal Wall Down Mastoidectomy: A Prospective, Randomized Trial
NCT ID: NCT03902938
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2018-10-02
2022-07-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Biodesign Otologic Graft
Graft following canal wall down mastoidectomy.
Biodesign Otologic graft
Patient's mastoid cavity will be covered with porcine small intestine submucosa, Biodesign.
Autograft temporalis fascia
Graft following canal wall down mastoidectomy.
Autograft temporalis fascia
Patient's mastoid cavity will be covered with covered with autograft.
Interventions
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Biodesign Otologic graft
Patient's mastoid cavity will be covered with porcine small intestine submucosa, Biodesign.
Autograft temporalis fascia
Patient's mastoid cavity will be covered with covered with autograft.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Henry Ford Health System
OTHER
Responsible Party
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Principal Investigators
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Seilesh Babu, MD
Role: PRINCIPAL_INVESTIGATOR
Physician of record
Locations
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Ascension Providence Hospital, Novi Campus
Novi, Michigan, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Sheehy JL. Cholesteatoma surgery: canal wall down procedures. Ann Otol Rhinol Laryngol. 1988 Jan-Feb;97(1):30-5. doi: 10.1177/000348948809700106.
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.
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.
Other Identifiers
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1322212
Identifier Type: -
Identifier Source: org_study_id