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Chitogel CSK-4 Gel as Packing in Tympanoplasty Surgery

NCT04783233 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2025-12-19

No results posted yet for this study

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.

Conditions

  • Tympanoplasty Surgery

Interventions

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.

Sponsors & Collaborators

  • Henry Ford Health System

    lead OTHER

Principal Investigators

  • Brent Wilkerson, MD · Physician of Record

Eligibility

Min Age
19 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-14
Primary Completion
2021-11-03
Completion
2021-11-03

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04783233 on ClinicalTrials.gov