Chitogel CSK-4 Gel as Packing in Tympanoplasty Surgery

Ascension South East Michigan

Status: Withdrawn

Conditions: Tympanoplasty Surgery

Treatments: Biological: Chitosan succinamide; Biological: Gelfoam

Study type: Observational

Funder types: Other

Identifiers

NCT04783233

1685638

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 19 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 2 patient groups

Packing with Gelfoam

Description:

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.

Treatment:

Biological: Gelfoam

Packing with Chitosan succinamide

Description:

The surgical intervention and tympanoplasty will be performed as normal. The middle ear and external canal will be packed Chitosan succinamide.

Treatment:

Biological: Chitosan succinamide