NCT04783233

Chitogel CSK-4 Gel as Packing in Tympanoplasty Surgery

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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: All
• Age: 19 Years – 100 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Tympanoplasty Surgery

Interventions

Type	Name	Description
BIOLOGICAL	Chitosan succinamide	Chitogel will be tested for suitability as a packing material in tympanoplasty surgery.
BIOLOGICAL	Gelfoam	Gelfoam is the current packing material for tympanoplasty surgery.

Timeline

• Start date: 2021-01-14
• Primary completion: 2021-11-03
• Completion: 2021-11-03
• First posted: 2021-03-05
• Last updated: 2025-12-19

Locations

1 site across 1 country: United States