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

Otologic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03902938
• Other study ID #: 1322212
• Status: Withdrawn
• Phase: Phase 4
• Start date: October 2, 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 canal wall down mastoidectomy (CWDM) healing outcomes using Biodesign® small intestine submucosa graft compared to autologous temporalis fascia graft.

Description:

Patients 18 or older will undergo primary canal wall down mastoidectomy. Patients with known biologic sensitivity or cultural objection to use of porcine materials will be excluded. 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.

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• Status: Withdrawn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 canal wall mastoidectomy

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Ear Diseases
• Otologic Disease

Intervention

Biological:
• Biodesign Otologic graft
Patient's mastoid cavity will be covered with porcine small intestine submucosa, Biodesign.

Other:
• Autograft temporalis fascia
Patient's mastoid cavity will be covered with covered with autograft.

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

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. — View Citation

Gantz BJ, Wilkinson EP, Hansen MR. Canal wall reconstruction tympanomastoidectomy with mastoid obliteration. Laryngoscope. 2005 Oct;115(10):1734-40. — 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

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. — 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

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. — 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

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. — 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

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. — 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

Sheehy JL. Cholesteatoma surgery: canal wall down procedures. Ann Otol Rhinol Laryngol. 1988 Jan-Feb;97(1):30-5. Review. — View Citation

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

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epithelialization of the canal wall down mastoid cavity	Direct observation by surgeon	Evaluation at 1 month post-operatively.
Primary	Epithelialization of the canal wall down mastoid cavity	Direct observation by surgeon	Evaluation at 2 months post-operatively.
Primary	Epithelialization of the canal wall down mastoid cavity	Direct observation by surgeon	Evaluation at 3 months post-operatively.
Primary	Epithelialization of the canal wall down mastoid cavity	Direct observation by surgeon	Evaluation at 6 months post-operatively.
Secondary	Determination of dry cavity	Direct observation by surgeon	Evaluation at 1 month post-operatively
Secondary	Determination of dry cavity	Direct observation by surgeon	Evaluation at 2 months post-operatively
Secondary	Determination of dry cavity	Direct observation by surgeon	Evaluation at 3 months post-operatively
Secondary	Determination of dry cavity	Direct observation by surgeon	Evaluation at 6 months post-operatively
Secondary	Audio-metric outcome	Test the pure tone air conduction (average of 500, 1000 and 2000 Hz)	Evaluation at 3 months post-operatively
Secondary	Audio-metric outcome	Determine the Air Bone Gap by measuring the difference between the air conduction and bone conduction testing. The air bone gap is the difference between the 2 readings and must be present at 3 consecutive frequencies.	Evaluation at 3 months post-operatively
Secondary	Audio-metric outcome	The word recognition testing evaluates the patient's ability to repeat phonetically balanced words appropriate for their hearing level.	Evaluation at 3 months post-operatively
Secondary	Audio-metric outcome	Test the pure tone air conduction (average of 500, 1000 and 2000 Hz)	Evaluation at 6 months post-operatively
Secondary	Audio-metric outcome	Determine the Air Bone Gap by measuring the difference between the air conduction and bone conduction testing. The air bone gap is the difference between the 2 readings and must be present at 3 consecutive frequencies.	Evaluation at 6 months post-operatively
Secondary	Audio-metric outcome	The word recognition testing evaluates the patient's ability to repeat phonetically balanced words appropriate for their hearing level.	Evaluation at 6 months post-operatively