Chitogel CSK-4 Gel as Packing in Tympanoplasty Surgery

• ClinicalTrials.gov Identifier: NCT04783233
• Recruitment Status: Withdrawn
• First Posted: March 5, 2021
• Last Update Posted: January 20, 2022
• Sponsor: Ascension South East Michigan
• Information provided by (Responsible Party): Ascension South East Michigan

Study Description

Brief Summary:

Little innovation in the material used for middle ear packing has occurred over the past decade, despite the fact that animal models have shown increased acute inflammation and increased fibrosis in the long term histologically. Although Chitosan Succinamide has shown improved wound healing and hemostasis in the nasal cavity mucosa, it has yet to be used as a support material, hemostatic agent, and healing agent in the middle ear. This study will utilize Chitosan Succinamide as an alternative to purified gelatin foam as a support material in primary tympanoplasty surgery.

Condition or disease	Intervention/treatment
Tympanoplasty Surgery	Biological: Chitosan succinamide; Biological: Gelfoam

Detailed Description:

A prospective cohort study will be performed. Healthy adults (age > 18) with single tympanic membrane perforations who have been offered and agreed to undergo tympanoplasty surgery with fascia graft (either transcanal or post-auricular) will be recruited. The surgical intervention and procedure of tympanoplasty will be performed as normal, however, the packing material will be randomly chosen using a random number generator. The middle ear and external canal will then be packed with either Chitosan Succinamide or Gelfoam. The patients in both groups will be placed on ciprodex post-operatively for 4 weeks. The patients will be seen post-operatively at 1 week for photo documentation and removal of the lateral aspect of CS/CD or Gelfoam. The patients will be seen at 4 weeks for photo documentation and the remainder of packing removal. At 3 months and 1 year the patients will have photo documentation and an audiogram.

Study Design

• Study Type: Observational
• Actual Enrollment: 0 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: The Use of Chitosan Succinamide (Chitogel CSK-4) Gel as Packing in Tympanoplasty Surgery
• Actual Study Start Date: January 14, 2021
• Actual Primary Completion Date: November 3, 2021
• Actual Study Completion Date: November 3, 2021

Groups and Cohorts

Group/Cohort	Intervention/treatment
Packing with Gelfoam; Tympanoplasty surgery with fascia graft (either transcanal or post-auricular) will be preformed. The middle ear and external canal will then be packed with Gelfoam.	Biological: Gelfoam; Gelfoam is the current packing material for tympanoplasty surgery.
Packing with Chitosan succinamide; The surgical intervention and tympanoplasty will be performed as normal. The middle ear and external canal will be packed Chitosan succinamide.	Biological: Chitosan succinamide; Chitogel will be tested for suitability as a packing material in tympanoplasty surgery.; Other Names: Chitogel; CSK-4

Outcome Measures

Primary Outcome Measures :

1. External auditory canal healing [ Time Frame: Assess healing of auditory canal starting 1 week up to one year following surgery. ]
   Physician determines exposed bone and inflammatory response
2. Tympanic membrane healing [ Time Frame: Assess healing of auditory canal starting 1 week up to one year following surgery. ]
   Physician determines failed tympanic membrane healing and inflammatory response.

Eligibility Criteria

• Ages Eligible for Study: 19 Years to 100 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients eligible for primary tympanoplasty surgery.

Criteria

Inclusion Criteria:

• Healthy adults
• Single tympanic membrane perforation

Exclusion Criteria:

• Chronic recurrent infection or otorrhea
• Previous ear surgery for the study ear
• Shellfish allergy
• Cerebral Spinal Fluid (CSF) leak concern

Contacts and Locations

Locations

United States, Michigan

Ascension Providence Hospital Novi Campus

Novi, Michigan, United States, 48374

Sponsors and Collaborators

Ascension South East Michigan

Investigators

• Principal Investigator: Brent Wilkerson, MD; Physician of Record

More Information

Publications:

Valentine R, Athanasiadis T, Moratti S, Hanton L, Robinson S, Wormald PJ. The efficacy of a novel chitosan gel on hemostasis and wound healing after endoscopic sinus surgery. Am J Rhinol Allergy. 2010 Jan-Feb;24(1):70-5. doi: 10.2500/ajra.2010.24.3422.

Ngoc Ha T, Valentine R, Moratti S, Robinson S, Hanton L, Wormald PJ. A blinded randomized controlled trial evaluating the efficacy of chitosan gel on ostial stenosis following endoscopic sinus surgery. Int Forum Allergy Rhinol. 2013 Jul;3(7):573-80. doi: 10.1002/alr.21136. Epub 2013 Jan 16.

Dogru S, Haholu A, Gungor A, Kucukodaci Z, Cincik H, Ozdemir T, Sen H. Histologic analysis of the effects of three different support materials within rat middle ear. Otolaryngol Head Neck Surg. 2009 Feb;140(2):177-82. doi: 10.1016/j.otohns.2008.10.023.

• Responsible Party: Ascension South East Michigan
• ClinicalTrials.gov Identifier: NCT04783233
• Other Study ID Numbers: 1685638
• First Posted: March 5, 2021
• Last Update Posted: January 20, 2022
• Last Verified: January 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Ascension South East Michigan:

Chitogel; Tympanoplasty; Support material

Additional relevant MeSH terms:

Chitosan; Gelatin Sponge, Absorbable; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Chelating Agents; Sequestering Agents; Hemostatics; Coagulants