Use of Biodesign® Otologic Graft in Tympanoplasty

Tympanic Membrane Perforation Clinical Trial

Official title:

Use of Biodesign® Otologic Graft in Tympanoplasty: A Prospective, Randomized Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03904316
• Other study ID #: 1322227
• Status: Withdrawn
• Phase: Phase 4
• Start date: October 3, 2018
• Est. completion date: July 1, 2022

Study information

• Verified date: August 2022
• Source: Ascension South East Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing primary tympanoplasty without mastoidectomy.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Tympanic Membrane Perforation

Intervention

Biological:
• Biodesign Otologic graft
Acellular matrix derived from porcine small intestine submucosa

Other:
• Autologous temporalis fascia
An autologous graft for tympanic membrane repair

Locations

Country	Name	City	State
United States	Ascension Providence Hospital, Novi Campus	Novi	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Ascension South East Michigan

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

JANSEN C. CARTILAGE--TYMPANOPLASTY. Laryngoscope. 1963 Oct;73:1288-301. — View Citation

Knoll LD. Use of porcine small intestinal submucosal graft in the surgical management of Peyronie's disease. Urology. 2001 Apr;57(4):753-7. — View Citation

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. Review. — View Citation

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. — View Citation

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. Epub 2007 Feb 8. — View Citation

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. — View Citation

ORTEGREN U. MYRINGOPLASTY. A 4-YEAR SERIES REVIEWED 2 YEARS AFTER OPERATION. Acta Otolaryngol Suppl. 1964;188:SUPPL 188:234+. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

SHEA JJ Jr. Vein graft closure of eardrum perforations. J Laryngol Otol. 1960 Jun;74:358-62. — View Citation

Spiegel JH, Kessler JL. Tympanic membrane perforation repair with acellular porcine submucosa. Otol Neurotol. 2005 Jul;26(4):563-6. — View Citation

Storrs L. Myringoplasty. Laryngoscope. 1966 Feb;76(2):185-95. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of graft take after tympanoplasty	Microscopically evaluate tympanic membrane for perforation closure	1 month postoperatively by the surgeon
Primary	Assessment of graft take after tympanoplasty	Microscopically evaluate tympanic membrane for perforation closure	2 months postoperatively by the surgeon
Primary	Assessment of graft take after tympanoplasty	Microscopically evaluate tympanic membrane for perforation closure	3 months postoperatively by the surgeon
Primary	Assessment of graft take after tympanoplasty	Microscopically evaluate tympanic membrane for perforation closure	6 months postoperatively by the surgeon
Secondary	Measurement of Hearing Parameters	Test the pure tone conduction (average of 500, 1000 and 2000 Hz).	Measure hearing parameters preoperatively
Secondary	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.	Measure hearing parameters preoperatively.
Secondary	Measurement of Hearing Parameters	Test Word Recognition for 50-2 syllables words	Measure hearing parameters preoperatively
Secondary	Measurement of Hearing Parameters	Test the pure tone conduction (average of 500, 1000 and 2000 Hz).	Measure hearing parameters 3 months postoperatively
Secondary	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
Secondary	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
Secondary	Measurement of Hearing Parameters	Test the pure tone conduction (average of 500, 1000 and 2000 Hz).	Measure hearing parameters 6 months postoperatively
Secondary	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
Secondary	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