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The trial was stopped as the benefit was challenging to determine in preliminary usage.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Autograft tympanic membrane repair | Active Comparator | Patient's perforated tympanic membrane will be repaired with autologous temporalis fascia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biodesign Otologic graft | Biological | Acellular matrix derived from porcine small intestine submucosa |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of Hearing Parameters | Test the pure tone conduction (average of 500, 1000 and 2000 Hz). | Measure hearing parameters preoperatively |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seilesh Babu, MD | Michigan Ear Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ascension Providence Hospital, Novi Campus | Novi | Michigan | 48374 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14623693 | Background | 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. | |
| 17710604 | 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. |
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| ID | Term |
|---|---|
| D018058 | Tympanic Membrane Perforation |
| ID | Term |
|---|---|
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D014947 | Wounds and Injuries |
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| Autologous temporalis fascia | Other | An autologous graft for tympanic membrane repair |
|
| Measure hearing parameters preoperatively. |
| Measurement of Hearing Parameters | Test Word Recognition for 50-2 syllables words | Measure hearing parameters preoperatively |
| Measurement of Hearing Parameters | Test the pure tone conduction (average of 500, 1000 and 2000 Hz). | Measure hearing parameters 3 months postoperatively |
| 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. | Measure hearing parameters 3 months postoperatively |
| Measurement of Hearing Parameters | The word recognition testing evaluates the patient's ability to repeat phonetically balanced words appropriate for his/her hearing level. | Measure hearing parameters 3 months postoperatively |
| Measurement of Hearing Parameters | Test the pure tone conduction (average of 500, 1000 and 2000 Hz). | Measure hearing parameters 6 months postoperatively |
| 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. | Measure hearing parameters 6 months postoperatively |
| Measurement of Hearing Parameters | The word recognition testing evaluates the patient's ability to repeat phonetically balanced words appropriate for his/her hearing level. | Measure hearing parameters 6 months postoperatively |
| 17564175 | 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. |
| 23956139 | 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. |
| 14073760 | Background | JANSEN C. CARTILAGE--TYMPANOPLASTY. Laryngoscope. 1963 Oct;73:1288-301. doi: 10.1288/00005537-196310000-00006. No abstract available. |
| 11306396 | 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. |
| 23777420 | 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. |
| 29290312 | Background | 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. |
| 17287942 | 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. |
| 20723784 | 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. |
| 14146678 | Background | ORTEGREN U. MYRINGOPLASTY. A 4-YEAR SERIES REVIEWED 2 YEARS AFTER OPERATION. Acta Otolaryngol Suppl. 1964;188:SUPPL 188:234+. No abstract available. |
| 24214917 | Background | 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. |
| 23032665 | Background | 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. |
| 14624898 | 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. |
| 18209120 | 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. |
| 13854782 | Background | SHEA JJ Jr. Vein graft closure of eardrum perforations. J Laryngol Otol. 1960 Jun;74:358-62. doi: 10.1017/s002221510005670x. No abstract available. |
| 16015147 | 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. |
| 5324120 | Background | Storrs L. Myringoplasty. Laryngoscope. 1966 Feb;76(2):185-95. doi: 10.1288/00005537-196602000-00001. No abstract available. |
| 27273405 | Background | 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. |