Chitogel CSK-4 Gel as Packing in Tympanoplasty Surgery

Study Overview
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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.

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

Conditions
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Tympanoplasty Surgery

Intervention / Treatment
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* Biological: Chitosan succinamide
* Biological: Gelfoam


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Packing with Gelfoam<br>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<br>* Gelfoam is the current packing material for tympanoplasty surgery.<br>|
| Packing with Chitosan succinamide<br>The surgical intervention and tympanoplasty will be performed as normal. The middle ear and external canal will be packed Chitosan succinamide. | Biological: Chitosan succinamide<br>* Chitogel will be tested for suitability as a packing material in tympanoplasty surgery.<br>* Other names: CSK-4;|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chitogel, Tympanoplasty, Support material