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Chitogel CSK-4 Gel as Packing in Tympanoplasty Surgery

NCT ID: NCT04783233

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-14

Study Completion Date

2021-11-03

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Tympanoplasty Surgery

Keywords

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Chitogel Tympanoplasty Support material

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Gelfoam

Intervention Type BIOLOGICAL

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.

Chitosan succinamide

Intervention Type BIOLOGICAL

Chitogel will be tested for suitability as a packing material in tympanoplasty surgery.

Interventions

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Chitosan succinamide

Chitogel will be tested for suitability as a packing material in tympanoplasty surgery.

Intervention Type BIOLOGICAL

Gelfoam

Gelfoam is the current packing material for tympanoplasty surgery.

Intervention Type BIOLOGICAL

Other Intervention Names

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Chitogel CSK-4

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henry Ford Health System

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brent Wilkerson, MD

Role: PRINCIPAL_INVESTIGATOR

Physician of Record

Locations

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Ascension Providence Hospital Novi Campus

Novi, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 20109331 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23322408 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19201284 (View on PubMed)

Other Identifiers

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1685638

Identifier Type: -

Identifier Source: org_study_id