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Chitogel CSK-4 Gel as Packing in Tympanoplasty Surgery
N/A
Waitlist Available
Led By Brent Wilkerson, MD
Research Sponsored by Ascension South East Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assess healing of auditory canal starting 1 week up to one year following surgery.
Awards & highlights
No Placebo-Only Group
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assess healing of auditory canal starting 1 week up to one year following surgery.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assess healing of auditory canal starting 1 week up to one year following surgery.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
External auditory canal healing
Tympanic membrane healing
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Packing with GelfoamExperimental Treatment1 Intervention
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.
Group II: Packing with Chitosan succinamideExperimental Treatment1 Intervention
The surgical intervention and tympanoplasty will be performed as normal. The middle ear and external canal will be packed Chitosan succinamide.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gelfoam
2022
N/A
~370
Find a Location
Who is running the clinical trial?
Ascension South East MichiganLead Sponsor
18 Previous Clinical Trials
32,423 Total Patients Enrolled
Brent Wilkerson, MDPrincipal InvestigatorPhysician of Record