Chitogel CSK-4 Gel as Packing in Tympanoplasty Surgery

The Use of Chitosan Succinamide (Chitogel CSK-4) Gel as Packing in Tympanoplasty Surgery

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.

Study Overview

• Status: Withdrawn
• Conditions: Tympanoplasty Surgery
• Intervention / Treatment: Biological: Gelfoam; Biological: Chitosan succinamide

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 Type: Observational

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Novi, Michigan, United States, 48374
      • Ascension Providence Hospital Novi Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients eligible for primary tympanoplasty surgery.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Henry Ford Health System
• Investigators: Principal Investigator: Brent Wilkerson, MD, Physician of record

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2021
• Primary Completion (Actual): November 3, 2021
• Study Completion (Actual): November 3, 2021

Study Registration Dates

• First Submitted: January 26, 2021
• First Submitted That Met QC Criteria: March 3, 2021
• First Posted (Actual): March 5, 2021

Study Record Updates

• Last Update Posted (Estimated): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Tympanoplasty; Chitogel; Support material
• Additional Relevant MeSH Terms: Surgical Equipment; Equipment and Supplies; Surgical Sponges; Gelatin Sponge, Absorbable
• Other Study ID Numbers: 1685638

Drug and device information, study documents

• 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