Status:

WITHDRAWN

Chitogel CSK-4 Gel as Packing in Tympanoplasty Surgery

Lead Sponsor:

Henry Ford Health System

Conditions:

Tympanoplasty Surgery

Eligibility:

All Genders

19-100 years

Brief 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 t...

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 ...

Eligibility Criteria

Inclusion

  • Healthy adults
  • Single tympanic membrane perforation

Exclusion

  • Chronic recurrent infection or otorrhea
  • Previous ear surgery for the study ear
  • Shellfish allergy
  • Cerebral Spinal Fluid (CSF) leak concern

Key Trial Info

Start Date :

January 14 2021

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

November 3 2021

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT04783233

Start Date

January 14 2021

End Date

November 3 2021

Last Update

December 19 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Ascension Providence Hospital Novi Campus

Novi, Michigan, United States, 48374